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NCT01511536 · ClinicalTrials.gov registry record · Phase 1
Cabazitaxel and Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT01511536 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 38 participants.
The verdict
NCT01511536, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
Primary Objectives: * To determine the maximum tolerated dose, and dose limiting toxicities of cabazitaxel administered as a 1-hour infusion every 3 weeks in combination with oral daily abiraterone acetate and prednisone in participants with metastatic Castrate-resistant prostate cancer (CRPC) * To estimate the anti-tumor activity of cabazitaxel in combination with abiraterone acetate and prednisone in terms of prostate-specific antigen (PSA) response rate. Secondary Objectives: * To characterize the safety profile of the combination * To evaluate the pharmacokinetic profile of cabazitaxel and abiraterone in the proposed combination and dosing schedule * To assess preliminary antitumor activity of the combination in terms of progression-free survival, PSA progression free survival and objective response rate, and overall survival
Interventions
- DRUG Abiraterone acetate
- DRUG Prednisone 5 mg
- DRUG Cabazitaxel XRP6258
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-03 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01511536
The ClinicalTrials.gov registry entry for NCT01511536 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 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 3 interventions - of which Abiraterone acetate is the first listed.
NCT01511536 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01511536 about?
NCT01511536 is a clinical study titled "Cabazitaxel and Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer". Primary Objectives: * To determine the maximum tolerated dose, and dose limiting toxicities of cabazitaxel administered as a 1-hour infusion every 3 weeks in combination with oral daily abiraterone acetate and prednisone in participants with metastatic Castrate-resistant prostate cancer (CRPC) * To...
What is the current status of trial NCT01511536?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2012-03. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01511536?
The interventions under investigation include: Abiraterone acetate (DRUG), Prednisone 5 mg (DRUG), Cabazitaxel XRP6258 (DRUG).
Who is sponsoring clinical trial NCT01511536?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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