Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
311
Countries
8
Sites
29
Metastatic castration resistant prostate cancer (mCRPC)
1. Safety Lead-in: To evaluate the safety and tolerability, and to establish a RP2D, of treatment combinations that have not been evaluated in a separate study. 2. Efficacy phase: To evaluate the safety and tolerability for each treatment arm. 3. Efficacy phase: To estimate the PSA response rate for each treatment arm.
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Mar 2025 → ongoing
- Decision date (initial)
- 2024-07-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC · Orion Corporation
External identifiers
- EU CT number
- 2023-506288-33-00
- WHO UTN
- U1111-1292-6912
- ClinicalTrials.gov
- NCT06353386
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacogenetic, Pharmacokinetic, Safety, Efficacy, Pharmacogenomic, Pharmacodynamic
1. Safety Lead-in: To evaluate the safety and tolerability, and to establish a RP2D, of treatment combinations that have not been evaluated in a separate study.
2. Efficacy phase: To evaluate the safety and tolerability for each treatment arm.
3. Efficacy phase: To estimate the PSA response rate for each treatment arm.
Secondary objectives 6
- Efficacy phase: To estimate the ORR per PCWG Modified RECIST 1.1, as assessed by BICR, for each treatment arm.
- Efficacy phase: To evaluate rPFS per PCWG Modified RECIST 1.1, as assessed by BICR, for each treatment arm.
- Efficacy phase: To evaluate OS for each treatment arm.
- Efficacy phase: To evaluate the DOR as assessed by BICR for each treatment arm.
- Efficacy phase: To evaluate the TFST for each treatment arm.
- Efficacy phase: To evaluate the TTPP for each treatment arm.
Conditions and MedDRA coding
Metastatic castration resistant prostate cancer (mCRPC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10076506 | Castration-resistant prostate cancer | 10029104 |
| 20.0 | LLT | 10036910 | Prostate cancer NOS | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without small cell histology.
- Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6 months before screening.
- Evidence of disease progression from either, >4 weeks from last flutamide treatment, or >6 weeks from last bicalutamide or nilutamide treatment, if receiving first generation anti-androgen therapy as last treatment therapy.
- Current evidence of metastatic disease.
- Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or metastatic, hormone-sensitive prostate cancer or castration-resistant prostate cancer and have disease progression during or after treatment.
- Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥4 weeks before randomization.
- Participants who experienced adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load.
- Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
Exclusion criteria 20
- History of pituitary dysfunction.
- Poorly controlled diabetes mellitus.
- Active or unstable cardio/cerebro-vascular disease, including thromboembolic events and history of stroke or transient ischemic attack within 6 months before the first dose of study intervention, history of myocardial infarction within 6 months before the first dose of study intervention, New York Heart Association Class III or IV cardiac disease or congestive heart failure, coronary heart disease that is symptomatic, or unstable angina
- History or family history of long corrected QT interval (QTc) syndrome.
- Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or features suggestive of MDS/AML.
- History or current condition of adrenal insufficiency.
- History of (noninfectious) pneumonitis requiring steroids, or current pneumonitis.
- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
- Undergone major surgery, including local prostate intervention (except prostate biopsy) within 28 days before randomization, and has not recovered from the toxicities and/or complications.
- Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study intervention.
- Received a whole blood transfusion in the last 120 days before randomization (packed red blood cells and platelet transfusions are acceptable if not given within 28 days before randomization).
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- Received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first does of study intervention. Administration of killed vaccines is allowed.
- Diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy, or any other form of immunosuppressive therapy, within 7 days prior to the first dose of study intervention.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
- Active infection requiring systemic therapy.
- Concurrent active HBV or HCV infections.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- Number of participants who experience one or more dose-limiting toxicities (DLTs)
- Number of participants who experience one or more adverse events (AEs)
- Number of participants who discontinue study intervention due to an AE
- Prostate-specific antigen (PSA) response rate
Secondary endpoints 6
- Objective response rate (ORR)
- Radiographic progression-free survival (rPFS)
- Overall survival (OS)
- Duration of response (DOR)
- Time to first subsequent anticancer therapy (TFST)
- Time to pain progression (TTPP)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
SCP126226 · ATC
- Active substance
- Docetaxel
- Substance synonyms
- DOCETAXEL ANHYDROUS
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cabazitaxel 2-PROPANOL Solvate
SCP191833 · ATC
- Active substance
- Cabazitaxel 2-PROPANOL Solvate
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01CD04 — CABAZITAXEL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10441547 · Product
- Active substance
- Opevesostat Tosilate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9414228 · Product
- Active substance
- Olaparib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9414227 · Product
- Active substance
- Olaparib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 10
A02B · Product
- Active substance
- Drugs for Peptic Ulcer and Gastro-Oesophageal Reflux Disease (Gord)
- Pharmaceutical form
- -
- Route of administration
- ANTEGRADE EPICARDIAL CORONARY ARTERY INFUSION
- Authorisation status
- Authorised
- ATC code
- A02B — DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12512679 · ATC
- Active substance
- Hydrocortisone Acetate
- Substance synonyms
- 2-[(8S,9S,10R,13S,14S,17R)-17-HYDROXY-10,13-DIMETHYL-3,11-DIOXO-1,2,6,7,8,9,12,14,15,16-DECAHYDROCYCLOPENTA[A]PHENANTHREN-17-YL]-2-OXO-ETHYL] ACETATE, CORTISOL ACETATE
- Route of administration
- ANTEGRADE EPICARDIAL CORONARY ARTERY INFUSION
- Authorisation status
- Authorised
- ATC code
- H02AB09 — HYDROCORTISONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
A03FA · Product
- Pharmaceutical form
- PHF00008MIG
- Route of administration
- ANTEGRADE EPICARDIAL CORONARY ARTERY INFUSION
- Authorisation status
- Authorised
- ATC code
- A03FA — PROPULSIVES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP10332310 · ATC
- Active substance
- Dexamethasone Acetate
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
A04A · Product
- Pharmaceutical form
- -
- Route of administration
- ANTEGRADE EPICARDIAL CORONARY ARTERY INFUSION
- Authorisation status
- Authorised
- ATC code
- A04A — ANTIEMETICS AND ANTINAUSEANTS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP137925 · ATC
- Active substance
- Fludrocortisone Acetate
- Substance synonyms
- 9ALPHA-FLUOROHYDROCORTISONE 21-ACETATE, FLUOHYDROCORTISONE ACETATE
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- H02AA02 — FLUDROCORTISONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
H02A · Product
- Pharmaceutical form
- -
- Route of administration
- ANTEGRADE EPICARDIAL CORONARY ARTERY INFUSION
- Authorisation status
- Authorised
- ATC code
- H02A — CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
R06A · Product
- Pharmaceutical form
- -
- Route of administration
- ANTEGRADE EPICARDIAL CORONARY ARTERY INFUSION
- Authorisation status
- Authorised
- ATC code
- R06A — ANTIHISTAMINES FOR SYSTEMIC USE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
A02BC · Product
- Pharmaceutical form
- PHF00091MIG
- Route of administration
- ANTEGRADE EPICARDIAL CORONARY ARTERY INFUSION
- Authorisation status
- Authorised
- ATC code
- A02BC — PROTON PUMP INHIBITORS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
L03A · Product
- Pharmaceutical form
- -
- Route of administration
- ANTEGRADE EPICARDIAL CORONARY ARTERY INFUSION
- Authorisation status
- Authorised
- ATC code
- L03A — IMMUNOSTIMULANTS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Yingjie Liu
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Yingjie Liu
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Almac Clinical Services LLC ORG-100041692
|
Souderton, United States | Interactive response technologies (IRT) |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Laboratory analysis |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Ardena Bioanalysis B.V. ORG-100036987
|
Assen, Netherlands | Laboratory analysis |
Locations
8 EU/EEA countries · 29 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 6 | 2 |
| Finland | Ongoing, recruiting | 8 | 3 |
| France | Ongoing, recruiting | 28 | 4 |
| Germany | Ongoing, recruiting | 15 | 5 |
| Ireland | Ongoing, recruiting | 12 | 3 |
| Italy | Ongoing, recruiting | 22 | 4 |
| Poland | Ongoing, recruiting | 16 | 3 |
| Spain | Ongoing, recruiting | 20 | 5 |
| Rest of world
Colombia, Turkey, Australia, Taiwan, Israel, Japan, United Kingdom, United States, Korea, Republic of, Chile, Canada, New Zealand
|
— | 184 | — |
Investigational sites
Aalborg University Hospital
Department of Oncology, Hobrovej 18-22, 9000, Aalborg
Herlev Hospital
Department of Oncology, Borgmester Ib Juuls Vej 1, 2730, Herlev
Docrates Oy
Docrates Cancer Center, Saukonpaadenranta 2, 00180, Helsinki
HUS-Yhtymae
HUS Cancer Center, Haartmaninkatu 4, 00290, Helsinki
Vaasa Central Hospital
Department of Clinical Ongology, Hietalahdenkatu 2-4, 65130, Vaasa
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Bergonie
Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Assistance Publique Hopitaux De Paris
Medical Oncology, 20 Rue Leblanc, 75015, Paris
Les Hopitaux Universitaires De Strasbourg
Medical Oncology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
University Medical Center Hamburg-Eppendorf
Department of Internal Medicine II Oncological Clinical Trials Center, Martinistrasse 52, Eppendorf, Hamburg
Klinikum rechts der Isar der TU Muenchen AöR
Urologische Klinik und Poliklinik, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Heidelberg AöR
Clinic for medical oncology, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Charite Universitaetsmedizin Berlin KöR
Department for Urology, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Tuebingen AöR
Department for Urology, Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
St Vincent's University Hospital
Oncology, Elm Park Merrion Road, D04 T6F4, Dublin 4
Tallaght University Hospital
Oncology, Tallaght, D24 NR0A, Dublin 24
Cork University Hospital
Oncology, Wilton, T12 DC4A, Cork
Humanitas Research Hospital
U.O. di Oncologia medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Medical Oncology, Largo Francesco Vito 1, 00168, Rome
Centro Ricerche Cliniche Di Verona S.r.l.
N/A, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Fondazione IRCCS Istituto Nazionale Dei Tumori
Struttura Complessa Oncologia MEdica 1, Via Giacomo Venezian 1, 20133, Milan
Uniwersyteckie Centrum Kliniczne
Centrum Wsparcia Badań Klinicznych UCK Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oddział Badań Wczesnych Faz, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Clinico San Carlos
Medical Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
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 | 2024-09-13 | 2025-01-10 | |||
| Finland | 2024-09-02 | 2024-12-30 | |||
| France | 2024-09-23 | 2024-12-31 | |||
| Germany | 2024-09-05 | 2024-10-10 | |||
| Ireland | 2024-09-03 | 2025-01-10 | |||
| Italy | 2024-10-03 | 2025-03-11 | |||
| Poland | 2024-08-14 | 2024-08-21 | |||
| Spain | 2024-10-09 | 2024-12-26 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 8 · Art. 38 CTR
Temporary halt TH-66445
- Halt date
- 2025-01-08
- Member states concerned
- Poland
- Publication date
- 2025-01-14
- Reason
- Sponsor decision, Study management related
- Explanation
- This pause is due to the rapid speed of enrolment, and not due to an urgent safety measure. To ensure the number of randomized participants in the trial will not exceed the total allocation per protocol, we will briefly pause enrolment to allow sufficient time for the participants already in screening to complete their screening activities, before allowing additional participants to be screened. This does not impact participants already in screening or on treatment. All other procedures will not be halted. In addition, there are participants under evaluation for enrolment in certain countries for whom screening may continue beyond 08-Jan-2025. No new participants (other than those mentioned herein) will be enrolled until the pause is lifted.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-66434
- Halt date
- 2025-01-08
- Member states concerned
- Finland
- Publication date
- 2025-01-14
- Reason
- Sponsor decision, Study management related
- Explanation
- This pause is due to the rapid speed of enrolment, and not due to an urgent safety measure. To ensure the number of randomized participants in the trial will not exceed the total allocation per protocol, we will briefly pause enrolment to allow sufficient time for the participants already in screening to complete their screening activities, before allowing additional participants to be screened. This does not impact participants already in screening or on treatment. All other procedures will not be halted. In addition, there are participants under evaluation for enrolment in certain countries for whom screening may continue beyond 08-Jan-2025. No new participants (other than those mentioned herein) will be enrolled until the pause is lifted.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-66443
- Halt date
- 2025-01-08
- Member states concerned
- Spain
- Publication date
- 2025-01-14
- Reason
- Sponsor decision, Study management related
- Explanation
- This pause is due to the rapid speed of enrolment, and not due to an urgent safety measure. To ensure the number of randomized participants in the trial will not exceed the total allocation per protocol, we will briefly pause enrolment to allow sufficient time for the participants already in screening to complete their screening activities, before allowing additional participants to be screened. This does not impact participants already in screening or on treatment. All other procedures will not be halted. In addition, there are participants under evaluation for enrolment in certain countries for whom screening may continue beyond 08-Jan-2025. No new participants (other than those mentioned herein) will be enrolled until the pause is lifted.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-66432
- Halt date
- 2025-01-08
- Member states concerned
- Denmark
- Publication date
- 2025-01-14
- Reason
- Sponsor decision, Study management related
- Explanation
- This pause is due to the rapid speed of enrolment, and not due to an urgent safety measure. To ensure the number of randomized participants in the trial will not exceed the total allocation per protocol, we will briefly pause enrolment to allow sufficient time for the participants already in screening to complete their screening activities, before allowing additional participants to be screened. This does not impact participants already in screening or on treatment. All other procedures will not be halted. In addition, there are participants under evaluation for enrolment in certain countries for whom screening may continue beyond 08-Jan-2025. No new participants (other than those mentioned herein) will be enrolled until the pause is lifted.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-66442
- Halt date
- 2025-01-08
- Member states concerned
- Italy
- Publication date
- 2025-01-14
- Reason
- Sponsor decision, Study management related
- Explanation
- This pause is due to the rapid speed of enrolment, and not due to an urgent safety measure. To ensure the number of randomized participants in the trial will not exceed the total allocation per protocol, we will briefly pause enrolment to allow sufficient time for the participants already in screening to complete their screening activities, before allowing additional participants to be screened. This does not impact participants already in screening or on treatment. All other procedures will not be halted. In addition, there are participants under evaluation for enrolment in certain countries for whom screening may continue beyond 08-Jan-2025. No new participants (other than those mentioned herein) will be enrolled until the pause is lifted.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-66440
- Halt date
- 2025-01-08
- Member states concerned
- Ireland
- Publication date
- 2025-01-14
- Reason
- Sponsor decision, Study management related
- Explanation
- This pause is due to the rapid speed of enrolment, and not due to an urgent safety measure. To ensure the number of randomized participants in the trial will not exceed the total allocation per protocol, we will briefly pause enrolment to allow sufficient time for the participants already in screening to complete their screening activities, before allowing additional participants to be screened. This does not impact participants already in screening or on treatment. All other procedures will not be halted. In addition, there are participants under evaluation for enrolment in certain countries for whom screening may continue beyond 08-Jan-2025. No new participants (other than those mentioned herein) will be enrolled until the pause is lifted.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-67511
- Halt date
- 2025-01-08
- Member states concerned
- France
- Publication date
- 2025-01-22
- Reason
- Sponsor decision, Study management related
- Explanation
- This pause is due to the rapid speed of enrolment, and not due to an urgent safety measure. To ensure the number of randomized participants in the trial will not exceed the total allocation per protocol, we will briefly pause enrolment to allow sufficient time for the participants already in screening to complete their screening activities, before allowing additional participants to be screened. This does not impact participants already in screening or on treatment. All other procedures will not be halted. In addition, there are participants under evaluation for enrolment in certain countries for whom screening may continue beyond 08-Jan-2025. No new participants (other than those mentioned herein) will be enrolled until the pause is lifted.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-66438
- Halt date
- 2025-01-08
- Member states concerned
- Germany
- Publication date
- 2025-01-14
- Reason
- Sponsor decision, Study management related
- Explanation
- This pause is due to the rapid speed of enrolment, and not due to an urgent safety measure. To ensure the number of randomized participants in the trial will not exceed the total allocation per protocol, we will briefly pause enrolment to allow sufficient time for the participants already in screening to complete their screening activities, before allowing additional participants to be screened. This does not impact participants already in screening or on treatment. All other procedures will not be halted. In addition, there are participants under evaluation for enrolment in certain countries for whom screening may continue beyond 08-Jan-2025. No new participants (other than those mentioned herein) will be enrolled until the pause is lifted.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 58 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-506288-33_for pub | U01.00R |
| Protocol (for publication) | D1_Protocol_2023-506288-33_SM04_for pub | 06R |
| Protocol (for publication) | D4_Copyright Statement_eCOA Tablet_SM03_for pub | 04DEC2024 |
| Protocol (for publication) | D4_Subject questionnaire_eCOA Handheld_SM03_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DEU_EN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DNK_EN_SM04_for pub | 2.00 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ESP_ES_for pub | 04APR2024R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FIN_FI_SM04_for pub | 25JUN2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_for pub | March 2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_IRL_EN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_for pub | 22JAN2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_POL_PL_SM04_for pub | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Advertisement_0602_FIN_FI_for pub | 26JUN2024R |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_FRA_FR_for pub | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_FRA_FR_for pub | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_IRL_EN_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_FIN_FI_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_IRL_EN_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_Tissue brochure_FIN_FI_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Social Media_0602_FIN_FI_for pub | 26JUN2024 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Summary PIS_IRL_EN_SM04_for pub | 0.03 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Website_POL_PL_SM04_for pub | 13JUN2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_FRA_FR_for pub | AM01_v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_FRA_FR_SM03_for pub | AM02v2.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DEU_DE_SM04-RFI003_for pub | AM04v4.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DNK_DA_NSM04_for pub | AM04v4.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ESP_ES_SM04_for pub | AM04v4.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FIN_FI_SM04-RFI008_for pub | 4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_FR_SM04_for pub | AM03v3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_IRL_EN_SM04_for pub | AM04 v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_for pub | AM01v1.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_SM04_for pub | AM04v4.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_POL_PL_SM04_for pub | AM04v4.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_SM04_for pub | 09JUN2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_add crossborder_DEU_DE_SM03_for pub | 0.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_data privacy_limited screening_ITA_IT_SM04_for pub | 18JUN2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_SM04_for pub | 09JUN2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_IRL_EN_SM03-RFI002_for pub | 0.00b |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_DEU_DE_SM04-RFI003_for pub | 0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_DNK_DA_SM04-RFI002_for pub | AM04v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_ESP_ES_SM04_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_FRA_FR_SM04_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_IRL_EN_SM04_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_ITA_IT_SM04_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_POL_PL_SM04_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_DEU_DE_SM03_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ESP_ES_SM03_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_FIN_FI_for pub | v0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_right not to know_DNK_DA_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_screening consent_FIN_FI_SM04-RFI008_for pub | 0.00 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_Cabazitaxel_SM03_for pub | 22FEB2024 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Q and RSI_Docetaxel_for pub | 02AUG2023 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-506288-33_DEU_DE_SM04_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-506288-33_ESP_ES_SM03_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-506288-33_FRA_FR_SM03_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-506288-33_ITA_IT_SM03_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-506288-33_POL_PL_SM03_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-506288-33_SM03_for pub | 3.0 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-08 | France | No conclusion 2024-06-24
|
2024-07-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-07 | No conclusion | 2024-09-04 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-04 | 2024-09-04 | ||
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-19 | France | Acceptable 2024-11-04
|
2024-11-04 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-29 | Acceptable 2024-11-04
|
2024-11-29 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-31 | France | Acceptable 2025-04-22
|
2025-04-22 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-27 | France | Acceptable 2025-09-04
|
2025-09-04 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-09-17 | Acceptable 2025-09-04
|
2025-09-17 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-18 | Acceptable | 2025-09-25 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-24 | France | Acceptable | 2025-10-08 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-01-27 | France | Acceptable | 2026-01-27 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-05-22 | France | Acceptable 2025-09-04
|
2026-05-22 |