- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01400555
A Safety Study of Abiraterone Acetate Administered in Combination With Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (mCRPC)
March 19, 2018 updated by: Cougar Biotechnology, Inc.
A Phase 1b Safety Study of Abiraterone Acetate (JNJ-212082) and Docetaxel in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open-label (patients and their doctors will know the identity of study drug administered), uncontrolled (patients are not assigned to treatment by chance), multicenter safety study of escalating dose levels of abiraterone acetate administered in combination with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC).
This study is conducted in 2 parts.
Part I consists of Screening, Treatment, assessment of dose-limiting toxicity (DLT), and determination of the maximum tolerated dose (MTD).
Participants are enrolled in sequential 6-subject cohorts (groups) and administered combination therapy (abiraterone acetate and docetaxel plus prednisone) according to a dose-escalation schedule.
The abiraterone acetate dose in this study will escalate from 500 mg to 1000 mg daily until the MTD is determined.
The MTD is the highest combination dose among the dose combinations investigated in this study at which no more than 2 (33%) of the patients in a cohort experience a DLT.
A DLT is defined by an adverse event occurring from Day 1 Week 2 (first dose of abiraterone acetate) to the day before the Day 1 Week 7 docetaxel infusion (3 weeks after the second docetaxel infusion); non-hematological toxicity >=Grade 3; Grade 4 neutropenia lasting more than 5 days, neutropenia complicated by fever, or systemic infection; thrombocytopenia <25,000/mcL, or any thrombocytopenia requiring platelet transfusion; and, any subjectively intolerable toxicity.
Part II of the study consists of Continuing Treatment, when patients remain at the allocated dose level, escalate to the combination MTD, or discontinuation of docetaxel (if toxicity or intolerability develops) and continue abiraterone acetate (up to 1000 mg/day) plus prednisone, until disease progression; End of Treatment, when posttreatment efficacy and safety will be documented; and Follow-Up, when survival status and new antitumor therapy are monitored.
Blood samples for pharmacokinetic and efficacy measurements will be collected at selected times during the study.
Safety will be monitored.
The total duration of study participation may be up to 36 months.
Oral abiraterone acetate will be administered as a single daily dose (500, 750, or 1000 mg).
Docetaxel will be administered once every 3 weeks as an intravenous (IV) infusion (60 or 75 mg/m2) over 1 hour.
Study participants will premedicate with oral dexamethasone 8 mg 1, 3, and 12 hours before the start of each docetaxel IV infusion.
Oral prednisone 5 mg will be administered twice daily.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States
-
-
New York
-
New York, New York, United States
-
-
Wisconsin
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Madison, Wisconsin, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 001
Cohort 1 Docetaxel 60 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
|
Experimental: 002
Cohort 2 Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
|
Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
|
Experimental: 003
Cohort 3 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 1000 mg/day + prednisone 10 mg/day
|
Experimental: 004
Cohort 4 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 750 mg/day + prednisone 10 mg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with a dose-limiting toxicity
Time Frame: Up through Week 6
|
Up through Week 6
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with prostate-specific antigen (PSA) response
Time Frame: Up to Month 36
|
Up to Month 36
|
Time to PSA progression
Time Frame: Up to Month 36
|
Up to Month 36
|
Objective response rate
Time Frame: Up to Month 36
|
Up to Month 36
|
Radiographic progression-free survival
Time Frame: Up to Month 36
|
Up to Month 36
|
Survival
Time Frame: Up to Month 36
|
Up to Month 36
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2011
Primary Completion (Actual)
May 12, 2014
Study Completion (Actual)
February 28, 2017
Study Registration Dates
First Submitted
July 21, 2011
First Submitted That Met QC Criteria
July 21, 2011
First Posted (Estimate)
July 22, 2011
Study Record Updates
Last Update Posted (Actual)
March 21, 2018
Last Update Submitted That Met QC Criteria
March 19, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR018712
- COU-AA-206 (Other Identifier: Cougar Biotechnology, Inc.)
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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