A Safety Study of Abiraterone Acetate Administered in Combination With Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
mCRPC
A Phase 1b Safety Study of Abiraterone Acetate (JNJ-212082) and Docetaxel in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
2 other identifiers
interventional
22
1 country
3
Brief Summary
The purpose of this study is to evaluate the maximum safe dose of abiraterone acetate administered in combination with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2011
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2011
CompletedFirst Posted
Study publicly available on registry
July 22, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2017
CompletedMarch 21, 2018
March 1, 2018
2.7 years
July 21, 2011
March 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with a dose-limiting toxicity
Up through Week 6
Secondary Outcomes (5)
Proportion of patients with prostate-specific antigen (PSA) response
Up to Month 36
Time to PSA progression
Up to Month 36
Objective response rate
Up to Month 36
Radiographic progression-free survival
Up to Month 36
Survival
Up to Month 36
Study Arms (4)
001
EXPERIMENTALCohort 1 Docetaxel 60 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
002
EXPERIMENTALCohort 2 Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
003
EXPERIMENTALCohort 3 Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 1000 mg/day + prednisone 10 mg/day
004
EXPERIMENTALCohort 4 Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 750 mg/day + prednisone 10 mg/day
Interventions
Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 750 mg/day + prednisone 10 mg/day
Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 1000 mg/day + prednisone 10 mg/day
Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
Docetaxel 60 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
Eligibility Criteria
You may qualify if:
- Adenocarcinoma of the prostate
- Metastatic disease documented by bone, computed tomography (CT), or magnetic resonance image (MRI) scan
- Surgical or medical castration with testosterone less than 50 ng/dL
- Prostate cancer progression documented by 1 of the following: PSA progression according to Prostate Cancer Working Group 2 (PCWG2) criteria, radiographic progression by modified Response Evaluation Criteria in Solid Tumors (RECIST) or bone scan
- Absolute neutrophil count \>1,500 cells/mm3
- Platelets \>100,000/µl
- Hemoglobin \>=10.0 g/dL
- Eastern Cooperative Group (ECOG) status score of \<=2.
You may not qualify if:
- Elevated liver function tests (LFTs): Serum bilirubin \>upper limit of normal (ULN), alanine (ALT) or aspartate (AST) aminotransferase \> 1.5 ULN concomitant with alkaline phosphatase \> 2.5 ULN
- Small cell carcinoma of the prostate
- Pulmonary or brain metastasis, liver metastasis is allowed if LFTs are not elevated
- Pre-existing neuropathy or severe fluid retention
- Prior cytotoxic chemotherapy for metastatic prostate cancer
- Prior therapy with other CYP17 inhibitor(s) or investigational agent(s) targeting the androgen receptor for metastatic prostate cancer
- Treatment of primary tumor within 4 weeks of Day 1 Week 1 with surgery, radiation, chemotherapy or immunotherapy
- Use of investigational drug within 4 weeks of Day 1 Week 1 or current enrollment in an investigational drug or device study
- Prior ketoconazole for prostate cancer
- Recent history of ischemic heart disease, electrocardiogram (ECG) abnormalities, or atrial fibrillation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Los Angeles, California, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Madison, Wisconsin, United States
Related Publications (1)
Huang X, Chau CH, Figg WD. Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures. J Hematol Oncol. 2012 Jul 2;5:35. doi: 10.1186/1756-8722-5-35.
PMID: 22747660DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cougar Biotechnology, Inc. Clinical Trial
Cougar Biotechnology, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2011
First Posted
July 22, 2011
Study Start
September 1, 2011
Primary Completion
May 12, 2014
Study Completion
February 28, 2017
Last Updated
March 21, 2018
Record last verified: 2018-03