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Cabazitaxel and Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Cabazitaxel and Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer

A Phase I/II Study of Cabazitaxel Combined With Abiraterone Acetate and Prednisone in Patients With Metastatic Castrate-Resistant Prostate Cancer (CRPC) Whose Disease Has Progressed After Docetaxel Chemotherapy

NCT01511536•Sanofi

View on ClinicalTrials.gov

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

Detailed Description

The study duration was to include a period for inclusion of up to 3 weeks and a 3-week treatment cycle(s). The participants might continue treatment until disease progression, unacceptable toxicity or willingness to stop followed by a minimum of 30-day follow-up

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Diagnosis of prostate adenocarcinoma proven histologically or cytologically, resistant to hormone therapy and previously treated with a docetaxel-containing regimen. In Phase 2 part, participants should have been treated with abiraterone acetate for at least 3 months and should continue treatment with abiraterone acetate before study entry
•Presence of metastatic prostate cancer.
•Participant must had progressive disease documented by rising PSA defined as 2 sequential increases above a previous lowest reference value (each PSA value must be obtained at least 1 week apart. A PSA value of at least 6 ng/mL was required at study entry). In Phase 1 part, in addition to rising PSA, progressive disease must be documented by:
•1. Increase in non-measureable or measurable disease, and/or
•2. Appearance of new lesions, including those on bone scan (≥2 new lesions on 2 consecutive bone scans if progressive disease diagnosed on bone scan only) consistent with progressive prostate cancer
•Effective castration (serum testosterone levels ≤0.50 ng/mL) by orchiectomy and/or luteinizing hormone-releasing hormone agonists /antagonist.
•1. If the participant had been treated with luteinizing hormone-releasing hormone agonists/antagonist (i.e., without orchiectomy), then this therapy had been initiated at least 4 weeks prior to cycle 1 day 1 and should be continued throughout the study.
•2. Prior anti-androgen therapy should be stopped before enrollment
•Eastern Cooperative Oncology Group performance status: 0 - 1.

Exclusion Criteria

•Previous treatment with mitoxantrone or cabazitaxel.
•Prior bone-seeking radio-isotope therapy (participants treated with Radium223 were not excluded from the study). Radiotherapy to ≥30% of bone marrow.
•Adverse events from any prior anticancer therapy of grade \>1 at the time of enrollment.
•Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study (except luteinizing hormone-releasing hormone agonist /antagonist and abiraterone acetate in the Phase 2 part of the study); small field single fraction palliative radiation within 1 week.
•Prior malignancy. Curatively treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer were allowed, as well as any other cancer for which chemotherapy had been completed ≥ 3 years ago and from which the participant had been disease-free for ≥ 3 years.
•Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to enrollment.
•Known brain or leptomeningeal metastases.
•Any severe acute or chronic medical condition which could impair the ability of the participant to participate to the study or to comply with the study procedures or interfere with interpretation of study results.
•Other concurrent serious illness or medical conditions
•Absence of signed and dated participant informed consent form prior to enrollment into the study.
+13 more criteria

Locations (4)

Investigational Site Number 840001

San Francisco, California, United States

Investigational Site Number 840002

New Haven, Connecticut, United States

Investigational Site Number 250001

Villejuif, France

Investigational Site Number 826001

Sutton, United Kingdom

Key Dates

Start Date

March 1, 2012

Primary Completion Date

July 1, 2014

Completion Date

December 1, 2014

Last Updated

July 28, 2016

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Cabazitaxel XRP6258

DRUG

Abiraterone acetate

DRUG

Prednisone 5 mg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 28, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Cabazitaxel and Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer

Inclusion Criteria

Exclusion Criteria

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