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

Completed · Phase 1

Conditions studied: Prostate Neoplasms, Prostate Cancer

In brief

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).

Key facts

Study ID

NCT01400555

Run by

Cougar Biotechnology, Inc.

People needed

22

Starts

2011-09-01

Expected to finish

2017-02-28

Last updated by the study team

2018-03-21

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — New York, New York, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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