Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
658
Countries
12
Sites
86
Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy
Study 1: To compare the efficacy, as measured by progression-free survival (PFS), of gedatolisib in combination with palbociclib and fulvestrant (Arm A) to fulvestrant (Arm C) in adults with HR+/HER2-/PIK3CA wild type (WT) advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with …
Key facts
- Sponsor
- Celcuity Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 6 Jun 2023 → ongoing
- Decision date (initial)
- 2023-05-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Celcuity, Inc.
External identifiers
- EU CT number
- 2022-502145-10-00
- WHO UTN
- U1111-1284-9702
- ClinicalTrials.gov
- NCT05501886
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacokinetic, Safety, Efficacy
Study 1:
To compare the efficacy, as measured by progression-free survival (PFS), of gedatolisib in combination with palbociclib and fulvestrant (Arm A) to fulvestrant (Arm C) in adults with HR+/HER2-/PIK3CA wild type (WT) advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with non-steroidal aromatase inhibitor (AI) therapy.
To compare efficacy, as measured by PFS, of gedatolisib in combination with fulvestrant (Arm B) to Arm C in adults with HR+/HER2-/PIK3CA WT advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with non-steroidal AI therapy.
Study 2: To compare the efficacy, as measured by PFS, of gedatolisib in combination with palbociclib and fulvestrant (Arm D) to alpelisib with fulvestrant (Arm E) in adults with HR+/HER2-/PIK3CA mutated (MT) advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with non-steroidal AI therapy
Secondary objectives 2
- Key Secondary – Study 1: • To compare the efficacy, as measured by overall survival (OS), of Arm A to Arm C, Arm B to Arm C, and Arm A to Arm B • To compare safety and tolerability between the treatment arms Key Secondary – Study 2: • To compare the efficacy, as measured by PFS, of Arm D to gedatolisib in combination with fulvestrant (Arm F) in adults with HR+/HER2- /PIK3CA MT advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with non-steroidal AI therapy • To compare the efficacy, as measured by OS, of Arm D to Arm E in adults with HR+/HER2- /PIK3CA MT advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with non-steroidal AI therapy • To compare the efficacy, as measured by OS, of Arm D to Arm F in adults with HR+/HER2- /PIK3CA MT advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with non-steroidal AI therapy • To compare safety and tolerability between the treatment arms
- Additional Secondary – Study 1: • To compare the efficacy, as measured by PFS, of Arm A to Arm B in adults with HR+/HER2-/PIK3CA WT advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with non steroidal AI therapy • Evaluate the contributory treatment effect of gedatolisib, palbociclib, and the combined treatment effect of gedatolisib and palbociclib in the stratified Cox proportional hazard model • To estimate and compare the efficacy, as measured by PFS and OS, among subjects with HER2-low status, defined as an IHC score of 1+ or IHC 2+ with a negative ISH score, and among subjects with HER-negative status, defined as an IHC score of 0 • To compare the efficacy, as measured by objective overall response rate (ORR); duration of response (DOR); time to response (TTR); and clinical benefit rate (CBR), of Arm A to Arm C, Arm B to Arm C, and Arm A to Arm B • To compare change in health status/quality of life (QOL) of Arm A to Arm C, Arm B to Arm C, and Arm A to Arm B. • Pharmacokinetics of gedatolisib Additional Secondary – Study 2: • To compare the efficacy, as measured by PFS, of Arm E to Arm F in adults with HR+/HER2- /PIK3CA MT advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with non-steroidal AI therapy • To estimate and compare the efficacy, as measured by PFS and OS, among subjects with HER2-low status, defined as an IHC score of 1+ or IHC 2+ with a negative ISH score, and among subjects with HER-negative status, defined as an IHC score of 0 • To compare the efficacy, as measured by ORR, DOR, TTR, and CBR, of Arm D to Arm E • To compare change in health status/QOL of Arm D to Arm E • Pharmacokinetics (PK) of gedatolisib
Conditions and MedDRA coding
Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10072737 | Advanced breast cancer | 10029104 |
| 28.0 | PT | 10085481 | Hormone receptor positive HER2 negative breast cancer | 100000004864 |
| 23.0 | PT | 10083234 | Hormone receptor positive breast cancer | 100000004864 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Manual assignment to Study 1 or Study 2 based upon PIK3CA mutational status during screening. Randomization within each study to treatment Arms A-F.
|
Randomised Controlled | None | Arm A: Gedatolisib 180 mg IV Weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off; Palbociclib 125 mg PO Daily for 3 weeks (21 days), followed by 1 week off; Fulvestrant 500 mg IM (2 × 5 mL injections) Every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1 Arm B: Gedatolisib 180 mg IV Weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off; Fulvestrant 500 mg IM (2 × 5 mL injections) Every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1 Arm C: Fulvestrant 500 mg IM (2 × 5 mL injections) Every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1 Arm D: Gedatolisib 180 mg IV Weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off; Palbociclib 125 mg PO Daily for 3 weeks (21 days), followed by 1 week off Fulvestrant 500 mg IM (2 × 5 mL injections) Every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1 Arm E: Alpelisib 300 mg PO (2 × 150 mg tablets) Daily for 4 weeks (28 days); Fulvestrant 500 mg IM (2 × 5 mL injections) Every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day Arm F: Gedatolisib 180 mg IV Weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off; Fulvestrant 500 mg IM (2 × 5 mL injections) Every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1 |
|
| 2 | Treatment Subjects may receive treatment until objective progressive disease, unacceptable toxicity, death, or withdrawal of consent, or any other discontinuation or withdrawal criterion is met, whichever occurs first.
|
Randomised Controlled | None | Arm A: Gedatolisib 180 mg IV Weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off; Palbociclib 125 mg PO Daily for 3 weeks (21 days), followed by 1 week off; Fulvestrant 500 mg IM (2 × 5 mL injections) Every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1 Arm B: Gedatolisib 180 mg IV Weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off; Fulvestrant 500 mg IM (2 × 5 mL injections) Every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1 Arm C: Fulvestrant 500 mg IM (2 × 5 mL injections) Every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1 Arm D: Gedatolisib 180 mg IV Weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off; Palbociclib 125 mg PO Daily for 3 weeks (21 days), followed by 1 week off Fulvestrant 500 mg IM (2 × 5 mL injections) Every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1 Arm E: Alpelisib 300 mg PO (2 × 150 mg tablets) Daily for 4 weeks (28 days); Fulvestrant 500 mg IM (2 × 5 mL injections) Every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day Arm F: Gedatolisib 180 mg IV Weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off; Fulvestrant 500 mg IM (2 × 5 mL injections) Every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1 |
|
| 3 | Follow-up All subjects will be followed every 12 weeks until the end of the study or for up to 48 months in Study 1 and Study 2 from the date of first subject randomized in the study for survival status and subsequent cancer treatment information, unless subject discontinues from the study earlier due to death, lost to follow‑up, withdrawal of consent (as OS is a major secondary efficacy endpoint, all subjects will be followed for survival), or study closure.
|
Not Applicable | None |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 16
- Adults ≥18 years of age and meet one of the following criteria: a. Women who are postmenopausal, defined as one of the following: i. Women 18–59 years of age (at the time of consent) with cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause, and serum estradiol and follicle-stimulating hormone (FSH) level within the laboratory’s reference range for postmenopausal females ii. Women ≥60 years of age (at the time of consent) with cessation of menses for at least 12 consecutive months iii. Documented bilateral oophorectomy iv. Medically confirmed ovarian failure b. Pre/perimenopausal women with medically-induced menopause by treatment with the luteinizing hormone-releasing hormone (LHRH) agonist goserelin, the gonadotropin releasing hormone (GnRH) agonist leuprolide (Lupron Depot), or equivalent agents to induce chemical menopause c. Male subjects must use an effective and/or acceptable contraceptive method from screening until 1 year after the last dose of study treatment
- Negative pregnancy test for women of childbearing potential. Female subjects of childbearing potential must use an effective and/or acceptable contraceptive method from screening until 1 year (2 years for fulvestrant) after the last dose of study treatment
- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced breast cancer
- Confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive, as per American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines (2020), based on most recent tumor biopsy utilizing an assay consistent with local standards
- Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance (Wolff 2018); if result by IHC is +2 (equivocal), an in situ hybridization test must be performed.
- Adequate tumor tissue for the analysis of PIK3CA mutational status by Therascreen®PIK3CA RGQ PCR test and identified PIK3CA status (mutant or nonmutant) b. Patients with confirmed PIK3CA MT are eligible for treatment with alpelisib in combination with fulvestrant (per PIQRAY® USPI, SmPC) and will be assigned to Study 2 c. All other patients who do not have confirmed PIK3CA MT will be assigned to Study 1 (unless Study 1 enrollment has been completed)
- Subjects must have documentation of radiological disease progression on or after the last prior treatment and also have (measurable disease according to RECIST v1.1, per local assessment a. In case of bone only disease i. Subjects must have at least one lytic bone lesion or mixed lytic/blastic bone lesion with identifiable soft tissue components that can be evaluated for changes in size ii. Subjects with only blastic bone lesions with no soft tissue component are not eligible for enrollment b. If radiotherapy was used during ≤3 months prior to randomization, the lesions selected for response assessment must be outside of the field of prior radiotherapy or have documented progression following radiation therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0–1
- Life expectancy of at least 3 months
- Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal aromatase inhibitor (AI)
- Resolution of all toxicities related to prior therapies or surgical procedures to NCI CTCAE v.5.0 Grade ≤1 (except alopecia)
- Left ventricular ejection fraction ≥50% at baseline
- At least 2 weeks beyond treatment with a targeted therapy, hormonal therapy, or major surgery and at least 3 weeks beyond immunotherapy and/or radiation therapy and recovered from all acute toxicities prior to randomization (adverse events [AEs] from prior anticancer agents recovered to Grade ≤1 or lower; except alopecia)
- Adequate bone marrow, hepatic, renal and coagulation function as defined by the following: a. Absolute neutrophil count ≥1.5 × 109/L (maintained without growth factor support within 7 days of C1D1) b. Hemoglobin ≥9.0 g/dL (90 g/L) (maintained without transfusion support within 7 days of C1D1) c. Platelets ≥100 × 109/L e. Potassium within normal limits, or corrected with supplements f. Calcium (corrected for serum albumin) and magnesium within normal limits or Grade ≤1 if judged clinically not significant by the Investigator g. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) (if no hepatic metastases); if hepatic tumor involvement, AST and ALT ≤5 × ULN h. Total bilirubin ≤1.5 × ULN (total bilirubin≤3.0 × ULN and direct bilirubin ≤1.5 × ULN in patients with Gilbert’s Syndrome) i. Serum amylase ≤1.5 × ULN (subjects with values >1.5 × ULN may be allowed if there are no clinical and radiological signs of pancreatitis) j. Serum lipase ≤1.5 × ULN (subjects with values >1.5 × ULN may be allowed if there are no clinical and radiological signs of pancreatitis) k. Prothrombin time (PT)/International Normalized Ratio (INR) ≤1.5 × ULN if not on anticoagulants l. Calculated creatinine clearance (CrCL) >50 mL/min using the Cockcroft and Gault equation i. Subjects with CrCL 40-50 mL/min who, in the opinion of the Investigator, are able to safely undertake study therapy may be eligible after discussion with Sponsor’s medical monitor
- Must be willing and able to comply with protocol-specified schedules of assessments, treatment plans, laboratory tests, and other study procedures
- Ability to understand the investigational nature of the study and sign the informed consent
Exclusion criteria 22
- History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥3 years
- Known and untreated, or active, brain or leptomeningeal metastases a. Subjects with previously treated central nervous system (CNS) metastases may be enrolled in the study if they meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment within at least 4 weeks prior to enrollment
- Patients with advanced, symptomatic, visceral spread that are at risk of life-threatening complication in the short-term
- History of clinically significant cardiovascular abnormalities such as: a. Congestive heart failure (New York Heart Association (NYHA) classification ≥ II [NYHA 1994]) within 6 months of study entry b. Myocardial infarction within 12 months of study entry c. History of any uncontrolled (or untreated) clinically significant cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle branch block, high grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block), supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months d. Uncontrolled hypertension defined by systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg, with or without antihypertensive medication (initiation or adjustment of antihypertensive medication[s] is allowed prior to screening) e. Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: i. Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, or history of clinically significant/symptomatic bradycardia ii. On screening, inability to determine the corrected QT interval using Fridericia’s formula (QTcF) on the ECG (i.e., unreadable or not interpretable) or QTcF >480 msec (determined by mean of triplicate ECGs at screening)
- Gastrointestinal tract disease resulting in an inability to absorb oral medication
- History of acute pancreatitis within 12 months of screening or past medical history of chronic pancreatitis
- Unable to swallow oral medication tablets/capsules
- Known hypersensitivity to the study drugs or their components
- History of pulmonary embolus or deep vein thrombosis diagnosed and/or treated within the previous 6 months
- History of drug induced pneumonitis or interstitial lung disease
- Subjects that, in the opinion of the Investigator, are unable to undertake study therapy or comply with study requirements a. Current uncontrolled medical, psychological, or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results b. Where applicable per country regulation, the subject must not currently be committed to an institution by virtue of an order issued either by judicial or administrative authorities
- Prior treatment with a phosphoinositide 3 kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor
- Pregnant or breast-feeding women
- Concurrent participation in another interventional clinical trial a. Subjects must agree not to participate in another clinical trial (other than observational trials) during participation in VIKTORIA-1 and until discontinuation of study treatment
- Prior treatment with chemotherapy and antibody drug conjugates (e.g., Enhertu®) for advanced disease is not permitted (prior adjuvant or neoadjuvant chemotherapy is permitted). Subjects whose disease progressed to metastatic or advanced within less than 6 months of completing adjuvant or neoadjuvant therapy will be considered as having received chemotherapy for advanced disease.
- More than 2 lines of prior endocrine therapy treatment for metastatic or locally advanced breast cancer
- Bone only disease that is only blastic with no soft tissue component
- Subjects with type 1 diabetes or uncontrolled type 2 diabetes
- Active human immunodeficiency virus (HIV) infection. a. Subjects with well controlled HIV infection may be allowed if CD4+ T-cell (CD4+) counts >350 cells/μL b. Subjects without a history of AIDS-defining opportunistic infections may be eligible for enrollment
- Known seropositive for or active viral infection with hepatitis B virus a. Hepatitis B surface antigen (HBsAg) positive b. HBsAg negative, hepatitis B surface antibody (anti-HBs) positive and/or hepatitis B core antibody (anti-HBc) positive and detectable viral DNA by PCR [Note: Subjects who are HBsAg negative and viral DNA PCR negative are eligible.]
- Known seropositive for, or active infection with hepatitis C virus a. Subjects with positive hepatitis C virus (HCV) antibodies are eligible with negative PCR test for HCV
- Medical history or concurrent conditions that are contraindicated for investigational treatments in this study (alpelisib) a. Active osteonecrosis of the jaw from previous or concurrent treatment with bisphosphonates/denosumab b. History of severe cutaneous reactions (e.g., Stevens-Johnson syndrome)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Study 1 & Study 2: Overall progression-free survival (PFS) curves using the Kaplan-Meier (KM) method, where PFS is defined as the time from randomization to death or the first documented radiological disease progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR)
Secondary endpoints 11
- Secondary (Study 2): Overall progression-free survival (PFS) curves using the Kaplan-Meier (KM) method, where PFS is defined as the time from randomization to death or the first documented radiological disease progression, whichever occurs first, confirmed by RECIST v1.1 criteria, as determined based on blinded independent central review (BICR)
- Secondary (Study 1 & Study 2): Overall survival (OS) curves and median time to death due to any cause, and landmark survival rates at 12, 24, 36, and 48 months using the Kaplan-Meier (KM) method Type, incidence, severity (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0), seriousness, and relationship to study medications of adverse events (AEs) and any laboratory abnormalities
- Additional secondary (study 1): Overall PFS curves using the KM method, where PFS is defined as the time from randomization to death or the first documented radiological disease progression, whichever occurs first, confirmed by RECIST v1.1 criteria, as determined based on BICR Coefficients for each independent factor in the model and the hazard ratios (HRs) with 95% confidence intervals (CIs)
- Additional secondary (study 1): Progression-free survival (PFS) and overall survival (OS) Kaplan-Meier (KM) curves by randomized arm, and the hazard ratio (HR) to measure Arms A vs C, B vs C, and A vs BOverall response rate (ORR): percentage of subjects who achieved an objective response according to RECIST v1.1 criteria (complete response [CR] or partial response [PR]) as assessed by blinded independent central review (BICR)
- Additional secondary (study 1): Duration of response (DOR): time from the assessment of initial response (PR or better) to death or first documented radiological disease progression as assessed by BICR, whichever occurs first; Time to response (TTR): time from randomization to the first assessment of PR or better as assessed by BICR; Clinical benefit rate (CBR): percentage of subjects with CR, PR, or stable disease (SD) >24 weeks as assessed by BICR
- Additional secondary (study 1): Functional Assessment of Cancer Therapy – 24 Breast (FACT-B) Trial Outcome Index (FACT-B TOI) questions + 4 FBSI questions to enable scoring as the NCCN/FACT Breast Symptom Index (NFBSI) – 28 questions total; Patient-Reported Outcomes Measurement Information System (PROMIS®) Short Form v2.0 – Physical Function 8c – 8 questions
- Additional secondary (study 1): EuroQol 5 Dimension 5 Level (EQ-5D-5L) – 5 questions, visual analog scale (VAS); Gedatolisib exposure estimated by population PK methods
- Additional secondary (study 2): Overall PFS curves using the KM method, where PFS is defined as the time from randomization to death or the first documented radiological disease progression, whichever occurs first, confirmed by RECIST v1.1, as determined by BICR; PFS and OS KM curves by arm, and the hazard ratio to measure Arms D vs E and D vs F; ORR % of subjects who achieved an objective response according to RECIST v1.1 (CR or PR) as assessed by BICR
- Additional secondary (study 2): DOR: time from the assessment of initial response (PR or better) to death or first documented radiological disease progression as assessed by BICR, whichever occurs first; TTR: time from randomization to the first assessment of PR or better as assessed by BICR; CBR: percentage of subjects with CR, PR, or SD >24 weeks as assessed by BICR
- Additional secondary (study 2): Functional Assessment of Cancer Therapy – 24 Breast (FACT-B) Trial Outcome Index (FACT-B TOI) questions + 4 FBSI questions to enable scoring as the NCCN/FACT Breast Symptom Index (NFBSI) – 28 questions total
- Additional secondary (study 2): Patient-Reported Outcomes Measurement Information System (PROMIS®) Short Form v2.0 – Physical Function 8c – 8 questions; EuroQol 5 Dimension 5 Level (EQ-5D-5L) – 5 questions, visual analog scale (VAS); Gedatolisib exposure estimated by population pharmacokinetic (PK) method
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9979206 · Product
- Active substance
- Gedatolisib
- Pharmaceutical form
- POWDER FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 180 mg milligram(s)
- Max total dose
- 7614 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- CELCUITY INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 7
Fulvestrant EVER Pharma 250 mg Injektionslösung in einer Fertigspritze
PRD6824954 · Product
- Active substance
- Fulvestrant
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 6000 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BA03 — FULVESTRANT
- Marketing authorisation
- 2201034.00.00
- MA holder
- EVER NEURO PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- labelling; packaging
Piqray 200 mg film-coated tablets
PRD8234907 · Product
- Active substance
- Alpelisib
- Substance synonyms
- (2S)-N1-(4-METHYL-5-(1-(1,1,1-TRIFLUORO-2-METHYLPROPAN-2-YL)PYRIDIN-4-YL)-1,3-THIAZOL-2-YL)PYRROLIDINE-1,2-DICARBOXAMIDE, BYL719
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 66360 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EM03 — -
- Marketing authorisation
- EU/1/20/1455/008
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- labeling and packaging
Piqray 50 mg and 200 mg film-coated tablets
PRD8235739 · Product
- Active substance
- Alpelisib
- Substance synonyms
- (2S)-N1-(4-METHYL-5-(1-(1,1,1-TRIFLUORO-2-METHYLPROPAN-2-YL)PYRIDIN-4-YL)-1,3-THIAZOL-2-YL)PYRROLIDINE-1,2-DICARBOXAMIDE, BYL719
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 66360 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EM03 — -
- Marketing authorisation
- EU/1/20/1455/005
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labeling and packaging
Piqray 150 mg film-coated tablets
PRD8234895 · Product
- Active substance
- Alpelisib
- Substance synonyms
- (2S)-N1-(4-METHYL-5-(1-(1,1,1-TRIFLUORO-2-METHYLPROPAN-2-YL)PYRIDIN-4-YL)-1,3-THIAZOL-2-YL)PYRROLIDINE-1,2-DICARBOXAMIDE, BYL719
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 66360 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EM03 — -
- Marketing authorisation
- EU/1/20/1455/002
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- labeling and packaging
IBRANCE 125 mg film-coated tablets
PRD8173525 · Product
- Active substance
- Palbociclib
- Substance synonyms
- PD-332,991, PD-0332991
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 37012.5 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/018
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- labeling and packaging
IBRANCE 100 mg film-coated tablets
PRD8173498 · Product
- Active substance
- Palbociclib
- Substance synonyms
- PD-332,991, PD-0332991
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 37012.5 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/017
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labelling; packaging
IBRANCE 75 mg film-coated tablets
PRD8173497 · Product
- Active substance
- Palbociclib
- Substance synonyms
- PD-332,991, PD-0332991
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 37012.5 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/016
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- labeling and packaging
Auxiliary 1
PRD10101671 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- MOUTHWASH
- Route of administration
- OROMUCOSAL USE
- Max daily dose
- 40.00 ml millilitre(s)
- Max total dose
- 246.4 ml millilitre(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- CELCUITY, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celcuity Inc.
- Sponsor organisation
- Celcuity Inc.
- Address
- 2800 Campus Drive Suite 140
- City
- Minneapolis
- Postcode
- 55441-2630
- Country
- United States
Scientific contact point
- Organisation
- Celcuity Inc.
- Contact name
- Celcuity Inc.
Public contact point
- Organisation
- Celcuity Inc.
- Contact name
- Celcuity Inc.
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| ClinDART, Inc. ORL-000000121
|
San Diego, United States | Other |
| Q-Square Business Intelligence, Corp. ORL-000000108
|
Boxborough, United States | Code 10 |
| Psi Cro AG ORG-100034251
|
Zug, Switzerland | On site monitoring, Code 11, Code 12, Code 2, Code 5 |
| Longboat Clinical Limited ORG-100045828
|
Limerick, Ireland | Other |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Psi CRO Greece Sole Individual LLC ORG-100047165
|
Athens, Greece | On site monitoring, Code 12, Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| Neogenomics Laboratories Inc. ORG-100041804
|
Aliso Viejo, United States | Other, Laboratory analysis |
| PPD International Holdings LLC ORG-100007655
|
Zaventem, Belgium | Other |
| OpAns, LLC. ORL-000000109
|
Durham, United States | Other |
Sponsor responsibilities
- Article 77 compliance
- Celcuity Inc.
- Contact point sponsor
- Celcuity Inc.
- Article 77 implementation
- Celcuity Inc.
Locations
12 EU/EEA countries · 86 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 16 | 8 |
| Belgium | Ongoing, recruitment ended | 22 | 9 |
| Bulgaria | Ongoing, recruitment ended | 14 | 5 |
| Czechia | Ongoing, recruitment ended | 14 | 3 |
| France | Ongoing, recruitment ended | 18 | 7 |
| Germany | Ongoing, recruitment ended | 25 | 7 |
| Greece | Ongoing, recruitment ended | 35 | 10 |
| Hungary | Ongoing, recruitment ended | 11 | 2 |
| Italy | Ongoing, recruitment ended | 22 | 9 |
| Poland | Ongoing, recruitment ended | 17 | 10 |
| Romania | Ongoing, recruitment ended | 17 | 6 |
| Spain | Ongoing, recruitment ended | 22 | 10 |
| Rest of world
Canada, Korea, Republic of, India, Brazil, United States, Mexico, Argentina, Singapore, United Kingdom, Taiwan, Australia
|
— | 425 | — |
Investigational sites
Klinik Hietzing
Department of Gynecology and Obstetrics, Wolkersbergenstraße 1, Hietzing, Vienna
Gemeinnutzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department of Internal Medicine III at the Paracelsus Medical University, Müllner Hauptstraße 48, 5020, Salzburg
Ordensklinikum Linz GmbH
Department of Internal Medicine I, Seilerstaette 4, 4020, Linz
Medical University Of Vienna
Department of Obstetrics and Gynecology, Waehringer Guertel 18-20, Alsergrund, Vienna
Universitatsklinikum St. Polten
Department of Internal Medicine I, Dunant-Platz 1, 3100, St. Poelten
Klinikum Wels-Grieskirchen GmbH
Department of Internal Medicine IV, Grieskirchner Strasse 42, 4600, Wels
Medizinische Universitaet Innsbruck
Department of Gynecology and Obstetrics, Anichstraße 35, 6020, Innsbruck
Medical University Of Graz
Department of Gynecology and Obstetrics, Neue Stiftingtalstrasse 6, 8010, Graz
CHR Verviers
Oncology & Hematology, Rue Du Parc 29, 4800, Verviers
Centre Hospitalier Regional De La Citadelle
Medial Oncology, Bld Du Douzieme-De-Ligne 1, 4000, Liege
UCL Mont-Godinne
Oncology Department, Avenue Dr-Gaston-Therasse 1, 5530, Yvoir
Verenigde Ziekenhuizen van Waas en Durme
Medical Oncology, Moerlandstraat 1, 9100, Sint-Niklaas
Cliniques Universitaires Saint-Luc
Medical Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
UZ Leuven
Gynaecologic Oncology, Herestraat 49, 3000, Leuven
Antwerp University Hospital
Gynaecologic Oncology, Drie Eikenstraat 655, 2650, Edegem
Algemeen Ziekenhuis Groeninge
Department of Oncology, President Kennedylaan 4, 8500, Kortrijk
Grand Hopital De Charleroi
Oncology & Hematology, Rue Du Campus Des Viviers 1, 6060, Charleroi
University Hospital St Marina Varna
Medical Oncology Clinic, Hristo Smirnenski St 1, 9010, Varna
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Department of Medical Oncology, Georgi Benkovski Street 100, 4500, Panagyurishte
University Specialized Hospital For Active Treatment In Oncology EAD
Medical Oncology Clinic, Ulitsa Plovdivsko Pole 6, 1756, Sofiya
Mbal Za Zhensko Zdrave Nadezhda OOD
Medical Oncology Clinic, Blaga Vest Street 3, 1330, Sofia
MBAL Serdika Ltd.
Second Department of Medical Oncology, Bulevard Prezident Linkiln 128, 1632, Sofia
Fakultni Nemocnice Motol A Homolka
Onkologická klinika 2. LF UK a FN Motol, V Uvalu 84/1, Motol, Prague
University Hospital Olomouc
Onkologická klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Thomayerova nemocnice
Onkologická klinika 1. LF UK a FTN, Videnska 800, Krc, Prague 4
Institut Bergonie
Service d'Oncologie Médicale, 229 Cours De L Argonne, 33000, Bordeaux
Centre Francois Baclesse
Service de pathologie mammaire, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Hospitalier Universitaire De Poitiers
Service d'Oncologie, 2 Rue De La Miletrie, 86000, Poitiers
Departmental Hospital Vendee
Service d'Onco-hématologie, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Assistance Publique Hopitaux De Marseille
CHU La Timone, Service d'Oncologie Médicale, 264 Rue Saint Pierre, 13005, Marseille
Institut Gustave Roussy
Service Cancer du Sein, 114 Rue Edouard Vaillant, 94800, Villejuif
Groupe Hospitalier Saint Vincent
Clinique Sainte Anne, Service d'Oncologie, 182 Route De La Wantzenau, 67000, Strasbourg
Universitatsklinikum Munster AöR
Clinic for Gynecology and Obstetrics – Section Senology, Gebaeude A1, Albert-Schweitzer-Campus 1, Muenster
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz KöR
Clinic and Polyclinic for Obstetrics and Womens’s Health, Langenbeckstraße 1, Oberstadt, Mainz
Klinikum Suedstadt Rostock
University Women's Hospital and Policlinic, Südring 81, Südstadt, Rostock
Helios Universitaetsklinikum Wuppertal
Breast Center and Department of Senology, Heusnerstrasse 40, Barmen, Wuppertal
Caritas Traegergesellschaft Saarbruecken mbH (CTS)
Women's Clinic, Rheinstrasse 2, Malstatt, Saarbruecken
Vivantes - Netzwerk fuer Gesundheit GmbH
Hematology and Oncology, Dieffenbachstrasse 1/1, Kreuzberg, Berlin
Klinikum Bayreuth GmbH
Clinic for Gynecology and Obstetrics, Preuschwitzer Straße 101, Roter Hügel, Bayreuth
Alexandra Hospital
Oncology Hematology Department, Vassilissas Sofias Avenue 80, 115 28, Athens
Bioclinic S.A.
Oncology Department, Mitropoleos 86, 546 22, Thessaloniki
General University Hospital Of Larissa
Department of Medical Oncology, P. O. Box 1425, 411 10, Larissa
Athens Medical Center S.A.
3rd Department of Oncology, Pylea, Asklipiou 10, Thessaloniki
Iaso Thessalia General Clinic Private Obstetrics S.A.
Department of Medical Oncology, 8th Km Old National Road Larissa-Athens, 410 00, Larissa
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
Oncology Department, Leoforos Mesogeion 264, 155 62, Cholargos
Euromedica General Clinic Of Thessaloniki
Oncology Unit, Kallas Marias 11, Gravias 2, Thessaloniki
University General Hospital Of Ioannina
Oncology Department, Niarchou Stavrou Avenue, 455 00, Ioannina
Metropolitan Hospital
4th Oncology Department, Ethnarchi Makariou 11, 185 47, Pireas
Theageneio Cancer Hospital
Β Chemotherapy Oncology Department, Papanastassiou Alexandrou 11, 546 39, Thessaloniki
University Of Debrecen
Klinikai Kozpont, Onkologiai Klinika, Nagyerdei Korut 98, 4032, Debrecen
Bacs-Kiskun Varmegyei Oktatokorhaz
Onkoradiologiai Kozpont, Nyiri Ut 38, 6000, Kecskemet
Azienda Socio Sanitaria Territoriale Di Monza
Centro di Ricerca Di Fase 1 / Phase 1 Research Center, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliero Universitaria Di Modena
Oncologia Medica / Medical Oncology, Largo Del Pozzo 71, 41124, Modena
Azienda Ospedaliera Universitaria Integrata Verona
Oncologia / Oncology, Piazzale Aristide Stefani 1, 37126, Verona
Fondazione Policlinico Universitario Campus Bio-Medico
Dipartimento Oncologia Medica / Department of Medical Oncology, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Ospedaliero Universitaria Parma
U.O.C. Oncologia Medica - Breast Unit / Medical Oncology C.O.U – Breast Unit, Viale Antonio Gramsci 14, 43126, Parma
European Institute Of Oncology S.r.l.
Divisione di Senologia Medica / Division of Medical Senology, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Sanitaria Universitaria Friuli Centrale
P.O. Santa Maria della Misericordia di Udine, Dipartimento di Oncologia, Via Pozzuolo 330, 33100, Udine
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Oncologia Medica / Medical Oncology COU, Largo Francesco Vito 1, 00168, Rome
Azienda USL Toscana Centro
SOC Oncologia Medica Santo Stefano / St. Stephen Medical Oncology COS, Via Suor Niccolina Infermiera 20/22, 59100, Prato
Instytut Centrum Zdrowia Matki Polki
Szpital Ginekologiczno-Położniczy i Pediatryczny, Klinika Onkologii, Ul. Rzgowska 281/289, 93-338, Lodz
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
I Przychodnia Lekarska Komed Roman Karaszewski II Osrodek Badan Klinicznych III Restauracja Rogatka Roman Karaszewski
PRZYCHODNIA LEKARSKA „KOMED”, Ul. Wojska Polskiego 6, 62-500, Konin
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Oddział w Krakowie, Klinika Onkologii Klinicznej, Ul. Garncarska 11, 31-115, Cracow
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Zachodniopomorskie Centrum Onkologii
Oddział Onkologii Klinicznej, Ul. Strzalowska 22, 71-730, Szczecin
Wojewodzki Szpital Specjalistyczny We Wroclawiu
Oddzial Chemioterapii z pododdziałem chemioterapii dziennej, Ul. Henryka Michala Kamienskiego 73a, 51-124, Wroclaw
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opolskie Centrum Onkologii Im Prof Tadeusza Koszarowskiego W Opolu
Klinika Onkologii z Odcinkiem Dziennym, Ul. Katowicka 66a, 45-001, Opole
Mazowiecki Szpital Wojewódzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Siedleckie Centrum Onkologii, Ul. Ksiecia Jozefa Poniatowskiego 26, 08-110, Siedlce
Lux Med Onkologia Sp. z o.o.
Szpital Szamocka, Oddzial onkologii klinicznej/chemioterapii, Ul. Szamocka 6, 01-748, Warsaw
Radiotherapy Center Cluj S.R.L.
Medical Oncology, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Centrul De Oncologie Sf Nectarie S.R.L.
Medical Oncology, Strada Caracal Nr. 109, 200746, Craiova
Oncopremium Team S.R.L.
Medical Oncology, Strada Progresului Nr. 36, 430295, Baia Mare
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Medical Oncology, Soseaua Fundeni 252, 022328, Bucharest
Onco Clinic Consult S.A.
Medical Oncology, 28J Sărarilor Street, 200516, Craiova Municipality, Dolj County, Strada Paltinis 120, 200094, Craiova
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Radiotherapy I, Strada Republicii 34-36, 400015, Cluj-Napoca
Hospital Universitario Ramon Y Cajal
Oncología Médica, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Del Mar
Oncología Médica, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Complexo Hospitalario Universitario De Santiago
Oncología Médica, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Fundacion Jimenez Diaz
Oncología Médica, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Catalan Institute Of Oncology
Oncología Médica, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Ruber Internacional
Oncología Médica, Calle La Maso 38, 28035, Madrid
Hospital San Pedro de Alcantara
Oncología Médica, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Universitario Infanta Cristina
Oncología Médica, Avenida Elvas S/n, 06006, Badajoz
Hospital Beata Maria Ana
Medical Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
University Clinical Hospital Virgen De La Arrixaca
Oncología Médica, Carretera De Cartagena S/n, El Palmar, Murcia
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2023-06-06 | 2023-09-27 | 2025-09-09 | ||
| Belgium | 2023-06-27 | 2023-08-11 | 2025-08-19 | ||
| Bulgaria | 2023-06-14 | 2023-09-12 | 2025-08-20 | ||
| Czechia | 2023-06-06 | 2023-06-08 | 2025-06-05 | ||
| France | 2023-07-14 | 2023-08-04 | 2025-07-11 | ||
| Germany | 2023-07-06 | 2023-09-18 | 2025-06-23 | ||
| Greece | 2023-08-02 | 2023-08-08 | 2025-09-12 | ||
| Hungary | 2023-06-12 | 2023-11-14 | 2025-09-03 | ||
| Italy | 2023-08-17 | 2023-08-30 | 2025-07-17 | ||
| Poland | 2023-06-12 | 2023-07-19 | 2025-09-03 | ||
| Romania | 2023-07-11 | 2023-07-25 | 2025-08-21 | ||
| Spain | 2023-07-31 | 2023-08-16 | 2025-09-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 146 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol _Protocol Clarification Letter _1 Protocol Redacted | 1 |
| Protocol (for publication) | D1_Protocol_2022-502145-10-00 redacted | 7.1 |
| Protocol (for publication) | D1_Protocol_GR_2022-502145-10-00 redacted | 7.1 |
| Protocol (for publication) | D1_Protocol_Protocol Clarification Letter_Protocol v7_1_Redacted | 1 |
| Protocol (for publication) | D4_ Patient facing documents EQ-5D-5L Redacted_DE | NA |
| Protocol (for publication) | D4_ Patient facing documents EQ-5D-5L_AT Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents EQ-5D-5L_BE-FR Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents EQ-5D-5L_BE-NL Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents EQ-5D-5L_ES Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents EQ-5D-5L_FR Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents EQ-5D-5L_IT Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents EQ-5D-5L_RO_Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents FACT-B RO_Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents FACT-B_AT Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents FACT-B_BE-FR Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents FACT-B_BE-NL Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents FACT-B_CZ Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents FACT-B_ES Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents FACT-B_FR Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents FACT-B_IT Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents PROMIS_AT Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents PROMIS_BE-FR Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents PROMIS_BE-NL Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents PROMIS_DE Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents PROMIS_ES Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents PROMIS_FR Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents PROMIS_IT Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents PROMIS_RO Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents_EQ-5D-5L_CZ Redacted | NA |
| Protocol (for publication) | D4_ Patient facing documents_PROMIS_CZ Redacted | NA |
| Protocol (for publication) | D4_ Patient faing documents FACT-B_DE redacted | NA |
| Protocol (for publication) | D4_Patient facing documents EQ-5D-5L_GR Redacted | NA |
| Protocol (for publication) | D4_Patient facing documents EQ-5D-5L_HU Redacted | NA |
| Protocol (for publication) | D4_Patient facing documents FACT-B_GR Redacted | NA |
| Protocol (for publication) | D4_Patient facing documents FACT-B_HU_Redacted | NA |
| Protocol (for publication) | D4_Patient facing documents PROMIS_GR Redacted | NA |
| Protocol (for publication) | D4_Patient facing documents PROMIS_HU_Redacted | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Information Flyer | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_public | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Redline | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Material_Flyer | N/A |
| Recruitment arrangements (for publication) | K2 Recruitment Material Referral Contact letter | NA |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_BEL_Recruitment material_Flyer_Dutch | 1 |
| Recruitment arrangements (for publication) | K2_BEL_Recruitment material_Flyer_French | 1 |
| Recruitment arrangements (for publication) | K2_Combination of Signatures for ICF | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material (Study Flyer) | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material description_Patient Referral Contact Letter | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material Site Flyer_public | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Information Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Referral Contact Letter | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Referral letter | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Referral Letter | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment Material_Flyer | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | Recruitment arrangements and informed consent procedure | 3 |
| Subject information and informed consent form (for publication) | ICF Placeholder | NA |
| Subject information and informed consent form (for publication) | K2_Recruitment Material Patient Welcome Kit | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_EN_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_Contact details for ICF_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_Contact details for the ICF_redline_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic_EN_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic_HU_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_Information Sheet and ICF_Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_Information Sheet and ICF_Main_Redline_Redacted | N/A |
| Subject information and informed consent form (for publication) | L1_Patient Card_HU_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF GDPR PP_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF GDPR_CHN_Certificate of translation_redacted | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF GDPR_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main (redacted) | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main CHN_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Redacted | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN_BE-FR_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN_BE-NL_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_CHN_Certificate of translation Redacted | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_CHN_Certificate of translation_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_HU_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redline_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_EN_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_HU_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_Redacted_redline | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner (redacted) | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PREGNANT PARTNER_BE-FR_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PREGNANT PARTNER_BE-NL_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Subject and Pregnant Partner_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Privacy_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP redline | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS Genetic_EN_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS Genetic_HU_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L2_Information Sheet and ICF_Pregnant Partner_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material (Patient Card) | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information_GP Information Letter_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF GDPR_CHN_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | Main ICF_Addendum_Radiation Exposure | 1.2 |
| Subject information and informed consent form (for publication) | Main ICF_redacted | 4.1 |
| Subject information and informed consent form (for publication) | Partner ICF | 1.1 |
| Subject information and informed consent form (for publication) | Patient Reimbursement Form | 1.0 |
| Subject information and informed consent form (for publication) | Pregnant Partner ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | Sponsor ICF Statement_redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Ibrance tablets USPI | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_fulvestrant | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Piqray | N/A |
| Synopsis of the protocol (for publication) | D1_Layperson Protocol Synopsis_BE-DE_2022-502145-10-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis for Laypersons_AT_2022-502145-10-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis for Laypersons_BE-FR_2022-502145-10-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis for Laypersons_BE-NL_2022-502145-10-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis for Laypersons_BG_2022_502145_10_00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis for Laypersons_CZ_2022-502145-10-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis for Laypersons_DE_2022-502145-10-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis for Laypersons_ES_2022-502145-10-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis for Laypersons_FR_2022-502145-10-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis for Laypersons_GR_2022-502145-10-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis for Laypersons_HU_2022-502145-10-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis for Laypersons_IT_2022-502145-10-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis for Laypersons_PL_2022-502145-10-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis for Laypersons_RO_2022-502145-10-00 | 2.0 |
Application history
20 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-12-21 | Belgium | Acceptable with conditions 2023-05-02
|
2023-05-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-05-11 | Belgium | Acceptable with conditions | 2023-06-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-05-11 | Acceptable with conditions | 2023-07-11 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-05-11 | Acceptable with conditions | 2023-06-26 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-05-11 | Acceptable with conditions | 2023-06-26 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-05-12 | Acceptable with conditions | 2023-06-20 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2023-05-12 | 2023-06-26 | ||
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2023-05-18 | Acceptable with conditions | 2023-06-07 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2023-05-19 | Acceptable with conditions | 2023-06-19 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2023-06-09 | Acceptable with conditions | 2023-07-03 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-08-18 | Acceptable with conditions | 2023-08-18 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-10 | 2023-11-20 | Belgium | Acceptable 2024-01-25
|
2024-01-29 |
| 13 | SUBSTANTIAL MODIFICATION | SM-11 | 2024-07-15 | Belgium | Acceptable 2024-10-16
|
2024-10-16 |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-25 | Acceptable 2024-10-16
|
2024-10-25 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-13 | 2024-11-29 | Belgium | Acceptable with conditions 2025-03-14
|
2025-03-14 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-03-31 | Belgium | Acceptable with conditions 2025-03-14
|
2025-03-31 |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-05-09 | Acceptable with conditions 2025-03-14
|
2025-05-09 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-07-03 | Acceptable with conditions | 2025-08-12 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-11-11 | Belgium | Acceptable 2026-02-18
|
2026-02-19 |
| 20 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-04-09 | Belgium | Acceptable 2026-02-18
|
2026-04-09 |