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

• Status: Completed
• Trial end date: 2017-02-28
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cougar Biotechnology, Inc.
• Treatments: Abiraterone Acetate; Docetaxel; Prednisone

Criteria

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.