Phase 1 Study of Abiraterone Acetate in Castration-resistant Prostate Cancer

• Status: Completed
• Trial end date: 2014-10-02
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to assess pharmacodynamics and safety of JNJ-212082 in order to select the recommended dose of JNJ-212082 for patients with castration resistant prostate cancer.

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

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Abiraterone Acetate

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate, but not with neuroendocrine differentiation or of small cell histology

• No Prior cytotoxic chemotherapy (including estramustine) for the treatment of prostate cancer

• Surgically or medically castrated, with testosterone levels of < 0.5 ng/mL

• PSA level of at least 2 ng/ml at Screening

• PSA progression according to PCWG2 eligibility criteria or objective progression by RECIST criteria for patients with measurable disease after androgen deprivation

Exclusion Criteria:

• Surgery or local prostatic intervention within 4 weeks of the first dose. In addition, any clinically relevant sequelae from the surgery have not resolved prior to initial treatment

• Radiotherapy, or immunotherapy within 4 weeks, or single fraction of palliative radiotherapy within 2 weeks of administration prior to initial treatment

• Known brain metastasis

• Uncontrolled hypertension (systolic BP greater than 160 mmHg or diastolic BP greater than 95 mmHg)

• Active or symptomatic viral hepatitis or chronic liver disease