Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ended
Participants planned
30
Countries
3
Sites
5
Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Part 1 (Phase Ib): Evaluate the safety and tolerability of KAND567, in combination with carboplatin therapy, and to determine the Recommended Phase II Dose (RPIID) of KAND567 in combination with carboplatin therapy in recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. (1) Part 2 (Phase IIa): Ev…
Key facts
- Sponsor
- Kancera AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Apr 2023 → 3 Apr 2025
- Decision date (initial)
- 2024-10-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515572-13-00
- EudraCT number
- 2022-002792-11
- ClinicalTrials.gov
- NCT06087289
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
Part 1 (Phase Ib): Evaluate the safety and tolerability of KAND567, in combination with carboplatin therapy, and to determine the Recommended Phase II Dose (RPIID) of KAND567 in combination with carboplatin therapy in recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. (1)
Part 2 (Phase IIa): Evaluate safety and tolerability of KAND567 in combination with carboplatin therapy at the RPIID of KAND567 in recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. (1)
(1) Defined as 1st relapse between 3 to 6 months after end of primary platinum-containing treatment; or 2nd or 3rd relapse within 6 months after last platinum-containing treatment.
Secondary objectives 4
- Evaluate Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Gynecologic Cancer Intergroup (GCIG) definitions.
- Assess signs of anti-tumor activity of KAND567 in combination with carboplatin therapy.
- Determine the plasma exposure of KAND567.
- Assess effect on pain symptoms of KAND567 in combination with carboplatin therapy.
Conditions and MedDRA coding
Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 15
- Histologically verified high-grade serous or high-grade endometrioid epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer.
- Participants* must have recurrent disease, defined as: 1st relapse 3 to 6 months after completion of the last dose of primary platinum containing treatment, or 2nd or 3rd relapse within 6 months after completion of the last dose of the latest platinum-containing regimen (platinum-free interval within 6 months). *Prior treatment with PARPi is allowed. In bevacizumab-naive patients, bevacizumab can be included as part of treatment after tumor progression on study drugs according to local clinical practice.
- Participants must have had platinum-based chemotherapy in the first-line setting (primary treatment or 1st relapse requiring chemotherapy).
- For BRCA status, samples must be available for analysis; for HRD status, samples should be available for analysis, if possible. If not already analyzed, the subject agrees to undergo analysis of HRD and BRCA status on primary tumor tissue and/or recurrent tumor tissue.
- ECOG performance status 0-2.
- Subjects must have at least 1 measurable disease or non-measurable disease according to RECIST 1.1 guidelines. Non-measurable disease must be evaluable using GCIG CA 125 criteria (CA 125 ≥ 2 x upper limit of normal [ULN]). If the subject has only 1 measurable lesion, this should not be the same lesion used for biopsy, nor should it be in a previously irradiated area.
- Able to take oral medications.
- Adequate organ function: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, Platelets > 100 x 10^9/L, Hemoglobin ≥ 80 g/dl, Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula, Total bilirubin ≤ ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ ULN.
- Consent to biopsy taken prior to starting treatment and Week 8 (± 1 week) of treatment.
- At least 18 years of age.
- Life expectancy of at least 12 weeks.
- Women of childbearing potential must use adequate birth control for the study duration and 6 months afterwards. She must use contraceptive methods with a failure rate of < 1% to prevent pregnancy* and drug exposure of a partner. Male partners must refrain from donating sperm from their partner’s first IMP dose until 6 months after their partner’s last IMP dose. * Combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD) or intrauterine hormone-releasing system (IUS); bilateral tubal occlusion, vasectomy, and sexual abstinence.
- Willingness and ability to comply with study procedures, visit schedules, study restrictions and requirements.
- Able to fully understand and participate in study-related procedures, including compliance and patient reported outcome (PRO).
- Written informed consent. Subjects must give informed consent prior to any study-specific procedure.
Exclusion criteria 22
- Ovarian sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial cancers, and cancer types not mentioned in the inclusion criteria.
- Primary platinum-refractory disease, defined as tumor progression during or within 12 weeks from end of first platinum treatment.
- Concurrent cancer therapy (including anti-hormonal therapy for breast cancer unless it is omitted at the latest at study enrollment).
- Received other than platinum-containing therapy for primary disease (first-line treatment).
- Received non-platinum-containing chemotherapy line (e.g. weekly paclitaxel) in treatment of recurrent ovarian cancer. Maintenance with bevacizumab and/or PARP-inhibitor is allowed.
- Treatment with an investigational agent concurrently, or where the last dose was administered within 5 elimination half-lives or where pharmacological activity may still be present as assessed by the Investigator.
- Previous malignant disease: subjects are not eligible for the study if actively being treated for invasive cancer other than ovarian cancer. Subjects with previous malignant disease other than ovarian cancer who are relapse-free and treatment-free for more than three years may enter this study (exception: anti-hormonal therapy, which must be omitted at the latest at study enrollment). Subjects with previous history of in situ carcinoma, stage 1A cervical cancer or non-invasive basal cell and squamous cell skin carcinoma can enter this trial.
- Immunodeficiency or organ transplant. Autoimmune or inflammatory condition that requires immunosuppressive or steroid therapy during the course of the study. Subjects using immunosuppressive medications within 14 days prior to the first IMP dose, except for topical medications (intranasal, inhaled, local injection, systemic [prednisolone equivalent 10 mg/day or less]) or as needed for hypersensitivity reactions such as CT scan premedication.
- Live vaccines within 28 days prior to the first IMP dose.
- Major surgery within 28 days prior to the first IMP dose, or not recovered from previous surgery to CTCAE (v5) grade 1 equivalent.
- Active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- Transient ischemic attack (TIA) or stroke, including bleeding, within the past 6 months.
- Brain metastases.
- Major cardiac dysfunction defined as > NYHA II.
- Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug.
- Serious, uncontrolled, and active infection at enrollment, as determined by the Investigator.
- Pregnancy or breastfeeding.
- Persistence of clinically relevant therapy-related toxicity from previous chemotherapy (≥ CTCAE grade 3, except for liver and gastrointestinal ≥ CTCAE grade 2).
- Need for concomitant use of drugs that are: moderate or strong inhibitors of CYP3A4 that may increase concentrations of KAND567; Inducers of CYP3A4 that may decrease concentrations of KAND567; highly dependent on CYP2B6, CYP2C8 or CYP3A4 for their metabolism where KAND567 may increase their concentrations. Treatment with such drugs should have been stopped at least five half-lives before initiation of KAND567 therapy. A list of drugs is provided in Appendix 3.
- Continuous use of herbal preparations (e.g., St. John’s wort) within 2 weeks prior to enrollment.
- Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (e.g., compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- Known or suspected hypersensitivity to any of the IMPs.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Occurrence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs).
- The safety endpoint parameters are frequency and severity of AEs, vital signs, electrocardiography (ECG), and the results of laboratory safety tests and urinalysis.
- RPIID of KAND567 in combination with carboplatin therapy will be determined based on safety and tolerability (Part 1/Phase Ib only).
Secondary endpoints 7
- ORR at Weeks 12 and 18, according to RECIST 1.1 and GCIG definitions, i.e., best overall response in subjects with measurable disease, or without measurable disease evaluable by CA 125.
- Progression-free survival (PFS) at Weeks 12 and 18.
- Overall survival (OS) at end of study.
- Disease control rate (DCR) (Complete response [CR] + Partial response [PR] + Stable disease [SD]) at Weeks 12 and 18.
- Duration of response according to RECIST 1.1 and GCIG definitions (time from documentation of tumor response to disease progression).
- KAND567 PK drug concentration data will be graphically visualized together with normalized PK drug concentration data from the previous KAN0001 study (i.e., no formal PK analysis will be performed).
- Change in pain score, as measured by the Numeric Rating Scale (NRS) from baseline (Week 1) to Weeks 4, 7, 10, 13, 16 and 20.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 19
PRD10117551 · Product
- Active substance
- (2R-2-2-AMINO-5-1S-1-PHENYLETHYLSULFANYL-13THIAZOLO45-DPYRIMIDIN-7-YLAMINO-4-METHYLPENTAN-1-OL Hydrochloride
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- KANCERA AB
- Paediatric formulation
- No
- Orphan designation
- No
Carboplatin ”Actavis”, koncentrat til infusionsvæske, opløsning
PRD925305 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 43174
- MA holder
- ACTAVIS GROUP PTC EHF.
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Ebewe 10 mg/ml koncentrat till infusionsvätska, lösning
PRD742837 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 14126
- MA holder
- EBEWE PHARMA
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Accord 10 mg/ml koncentrat till infusionsvätska, lösning
PRD2005432 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 25512
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin ”Accord”, koncentrat til infusionsvæske, opløsning
PRD2005407 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 41344
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Accord 10 mg/ml konsentrat til infusjonsvæske, oppløsning
PRD2005420 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 07-4965
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Accord 10 mg/ml koncentrat till infusionsvätska, lösning
PRD2005430 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 25512
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Actavis 10 mg/ml koncentrat till infusionsvätska, lösning
PRD925304 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 26883
- MA holder
- ACTAVIS GROUP PTC EHF.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin ”Accord”, koncentrat til infusionsvæske, opløsning
PRD2005406 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 41344
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Accord 10 mg/ml konsentrat til infusjonsvæske, oppløsning
PRD2005418 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 07-4965
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Accord 10 mg/ml konsentrat til infusjonsvæske, oppløsning
PRD415291 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 07-4965
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Accord 10 mg/ml konsentrat til infusjonsvæske, oppløsning
PRD2005419 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 07-4965
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin "Ebewe", koncentrat til infusionsvæske, opløsning
PRD727157 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 36002
- MA holder
- EBEWE PHARMA
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Accord 10 mg/ml koncentrat till infusionsvätska, lösning
PRD2005431 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 25512
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD669099 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 48062
- MA holder
- FRESENIUS KABI AB
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin ”Accord”, koncentrat til infusionsvæske, opløsning
PRD2005405 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 41344
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Accord 10 mg/ml koncentrat till infusionsvätska, lösning
PRD415312 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 25512
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Fresenius Kabi 10 mg/ml konsentrat til infusjonsvæske, oppløsning
PRD669101 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 10-8046
- MA holder
- FRESENIUS KABI NORGE AS OSLO
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin ”Accord”, koncentrat til infusionsvæske, opløsning
PRD415284 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 41344
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kancera AB
- Sponsor organisation
- Kancera AB
- Address
- Nanna Svartz Vag 4
- City
- Solna
- Postcode
- 171 65
- Country
- Sweden
Scientific contact point
- Organisation
- Kancera AB
- Contact name
- Robert Edfors
Public contact point
- Organisation
- Kancera AB
- Contact name
- Robert Edfors
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Link Medical ApS ORG-100020028
|
Copenhagen K, Denmark | Code 8 |
| IntoDNA S.A. ORL-000010227
|
Kraków, Poland | Laboratory analysis |
| Scandinavian CRO AB ORG-100042506
|
Uppsala, Sweden | On site monitoring, Code 11, Code 12 |
| ClinStorage AB ORG-100019155
|
Hagersten, Sweden | Other |
| Statisticon AB ORG-100052725
|
Uppsala, Sweden | Code 10 |
| Tamro AB ORG-100012530
|
Gothenburg, Sweden | Other |
| Ardena Pamplona S.L. ORG-100009998
|
Noain (Valle De Elorz), Spain | Other |
| Karolinska University Hospital ORG-100000573
|
Solna, Sweden | Laboratory analysis |
| Offspring Biosciences AB ORL-000012970
|
Södertälje, Sweden | Laboratory analysis |
| Scantox Sweden AB ORG-100025118
|
Molndal, Sweden | Laboratory analysis |
| Karolinska Institute ORL-000010225
|
Solna, Sweden | Laboratory analysis |
| MediCase AB ORG-100052682
|
Goteborg, Sweden | Data management |
Locations
3 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 10 | 1 |
| Norway | Ended | 10 | 1 |
| Sweden | Ended | 10 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Oslo University Hospital HF
gynaecological oncology, Radiumhospitalet, Montebello, Ullernchausséen 70, Oslo
Karolinska University Hospital
Oncology Pathology Eugeniav. 3, Eugeniavagen 3, 171 64, Solna
Uppsala University Hospital
KFUE Blod och tumörsjukdomar, ingång 101, Akademiska Sjukhuset, Uppsala, Sjukhusvagen 85, 751 85, Uppsala
Region Skane Skanes Universitetssjukhus
Gynaecological oncology, Barnv. 4, Entregatan 7, 222 42, Lund
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 |
|---|---|---|---|---|---|
| Denmark | 2023-11-09 | 2024-12-04 | 2024-03-18 | 2024-11-12 | |
| Norway | 2023-05-11 | 2025-04-03 | 2023-10-17 | 2024-11-12 | |
| Sweden | 2023-04-26 | 2025-03-18 | 2023-06-02 | 2024-11-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| KAN0007 Summary of results_redacted SUM-104459
|
2025-10-31T15:32:40 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| KAN0007 Lay person summary of results | 2025-10-31T15:32:45 | Submitted | Laypersons Summary of Results |
Documents 21 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | KAN0007 Lay person summary of results | 1 |
| Protocol (for publication) | D1_Protocol 2024-515572-13 | 5.0 |
| Recruitment arrangements (for publication) | Placeholder document | 1 |
| Recruitment arrangements (for publication) | Placeholder document | 1 |
| Recruitment arrangements (for publication) | Placeholder document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults fas 1b | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults fas 2a v7 | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults phase 1b | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults phase 1b | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults phase 2a | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults phase 2a | 7.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin Accord_dk | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin Accord_no | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin Actavis_dk | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin Ebewe_dk | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin Fresenius Kabi_dk | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin Fresenius Kabi_no | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Karboplatin Accord_se | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Karboplatin Actavis_se | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Karboplatin Ebewe_se | 1 |
| Summary of results (for publication) | KAN0007 Summary of results_redacted | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-12 | Sweden | Acceptable with conditions 2024-10-01
|
2024-10-01 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-14 | Sweden | Acceptable with conditions 2024-10-01
|
2025-02-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-13 | Sweden | Acceptable with conditions 2024-10-01
|
2025-03-13 |