Status:
COMPLETED
A Safety Study of Abiraterone Acetate Administered in Combination With Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Lead Sponsor:
Cougar Biotechnology, Inc.
Conditions:
Prostate Neoplasms
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 prosta...
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 escal...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2017
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01400555
Start Date
September 1 2011
End Date
February 28 2017
Last Update
March 21 2018
Active Locations (3)
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1
Los Angeles, California, United States
2
New York, New York, United States
3
Madison, Wisconsin, United States