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NCT02379390 · ClinicalTrials.gov registry record · Phase 2
Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enzalutamide
A Phase 2 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT02379390 is a Phase 2 study that was terminated before completion, run by Sanofi. The registered enrollment target is 8 participants.
The verdict
NCT02379390, a Phase 2 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of cabazitaxel at at 25 milligram per meter square (mg/m\^2) plus prednisone (Arm A) versus either enzalutamide at 160 milligram (mg) once daily or abiraterone acetate at 1000 mg once daily plus prednisone (Arm B) in chemotherapy-naïve participants with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have disease progression while receiving androgen receptor (AR) targeted therapy (abiraterone plus prednisone or enzalutamide) within 12 months of treatment initiation (≤12 months). Secondary Objective: * To compare efficacy for: * Prostate-specific antigen (PSA) response rate and Time to PSA progression (TTPP). * Progression Free Survival (PFS). * Overall Survival (OS). * Tumor response rate in participants with measurable disease (RECIST 1.1) * Pain response and time to pain progression. * Symptomatic skeletal events (SSE) rate and time to occurrence of any SSE. * To analyze messenger ribonucleic acids (mRNAs) including androgen-receptor splice variant 7 messenger RNA (AR-V7) as a biomarker in Circulating Tumor Cells (CTCs). * To evaluate safety in the 2 treatment arms.
Interventions
- DRUG Prednisone
- DRUG Abiraterone acetate
- DRUG Cabazitaxel XRP6258
- DRUG Ezalutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2015-06-17 |
| Est. Completion | 2018-05-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02379390
The ClinicalTrials.gov registry entry for NCT02379390 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Prednisone is the first listed.
NCT02379390 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02379390 about?
NCT02379390 is a clinical study titled "Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enzalutamide". Primary Objective: To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of cabazitaxel at at 25 milligram per meter square (mg/m\^2) plus prednisone (Arm A) versus either enzalutamide at 160 milligram (mg) once daily or abiraterone acetate at 1000 mg once daily pl...
What is the current status of trial NCT02379390?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2015-06-17. Estimated completion is 2018-05-10.
What interventions are being tested in trial NCT02379390?
The interventions under investigation include: Prednisone (DRUG), Abiraterone acetate (DRUG), Cabazitaxel XRP6258 (DRUG), Ezalutamide (DRUG).
Who is sponsoring clinical trial NCT02379390?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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