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A Safety Study of Abiraterone Acetate Administered in Combination With Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (mCRPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01400555
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Cougar Biotechnology, Inc.

Tracking Information
First Submitted Date  ICMJE July 21, 2011
First Posted Date  ICMJE July 22, 2011
Last Update Posted Date March 21, 2018
Actual Study Start Date  ICMJE September 1, 2011
Actual Primary Completion Date May 12, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
Proportion of patients with a dose-limiting toxicity [ Time Frame: Up through Week 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2011)
  • Proportion of patients with prostate-specific antigen (PSA) response [ Time Frame: Up to Month 36 ]
  • Time to PSA progression [ Time Frame: Up to Month 36 ]
  • Objective response rate [ Time Frame: Up to Month 36 ]
  • Radiographic progression-free survival [ Time Frame: Up to Month 36 ]
  • Survival [ Time Frame: Up to Month 36 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
  • Proportion of patients with prostate-specific antigen (PSA) response [ Time Frame: Up to Week 36 ]
  • Time to PSA progression [ Time Frame: Up to Week 36 ]
  • Objective response rate [ Time Frame: Up to Week 36 ]
  • Radiographic progression-free survival [ Time Frame: Up to Week 36 ]
  • Survival [ Time Frame: Up to Week 36 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study of Abiraterone Acetate Administered in Combination With Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Official Title  ICMJE A Phase 1b Safety Study of Abiraterone Acetate (JNJ-212082) and Docetaxel in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Neoplasms
  • Prostate Cancer
Intervention  ICMJE
  • Drug: Cohort 4
    Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 750 mg/day + prednisone 10 mg/day
  • Drug: Cohort 3
    Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 1000 mg/day + prednisone 10 mg/day
  • Drug: Cohort 2
    Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
  • Drug: Cohort 1
    Docetaxel 60 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
Study Arms  ICMJE
  • Experimental: 001
    Cohort 1 Docetaxel 60 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
    Intervention: Drug: Cohort 1
  • Experimental: 002
    Cohort 2 Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
    Intervention: Drug: Cohort 2
  • Experimental: 003
    Cohort 3 Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 1000 mg/day + prednisone 10 mg/day
    Intervention: Drug: Cohort 3
  • Experimental: 004
    Cohort 4 Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 750 mg/day + prednisone 10 mg/day
    Intervention: Drug: Cohort 4
Publications * 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2014)
22
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2011)
30
Actual Study Completion Date  ICMJE February 28, 2017
Actual Primary Completion Date May 12, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Belgium
 
Administrative Information
NCT Number  ICMJE NCT01400555
Other Study ID Numbers  ICMJE CR018712
COU-AA-206 ( Other Identifier: Cougar Biotechnology, Inc. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cougar Biotechnology, Inc.
Study Sponsor  ICMJE Cougar Biotechnology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Cougar Biotechnology, Inc. Clinical Trial Cougar Biotechnology, Inc.
PRS Account Cougar Biotechnology, Inc.
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP