A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer

• Status: Active, not recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate pharmacokinetics (PK) following a single dose and multiple dose treatment and the safety of apalutamide in Chinese participants with metastatic castration resistant prostate cancer (mCRPC) at dose of 240 milligram (mg).

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

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Androgens

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2

• Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features

• Metastatic disease as documented by bone scan or metastatic lesions by computed tomography or magnetic resonance imaging scans (visceral or lymph node disease). Lymph nodes in the pelvis must measure at least 1.5 centimeter in a short axis to be considered target lesion according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on the Prostate Cancer Working Group 2 (PCWG2) criteria

• Castration-resistant prostate cancer (PC) demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of prostate-specific antigen (PSA), at least 1 week apart, with the last PSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL)

• Prior hormonal interventions (including 1st generation antiandrogens [flutamide, bicalutamide, nilutamide], steroids, estrogens, finasteride, dutasteride) for PC are allowed. These therapies, except for gonadotropin releasing hormone analogs (GnRH) analogs and prednisone/prednisolone, must have been discontinued for minimally 4 weeks (2 weeks only for flutamide, nilutamide, or finasteride) before first dose of study drug

Exclusion Criteria:

• Known brain metastases

• Chemotherapy, or immunotherapy within 2 weeks or 5 half-lives of the drug prior to the first dose of study drug, whichever is longer, with a maximum of 4 weeks.

• Prior treatment with second-generation anti-androgens (example [eg], enzalutamide)

• Administration of an investigational therapeutic within 2 weeks or 5 half-lives of the drug prior to the first dose of study drug, whichever is longer, with a maximum of 4 weeks. And participant use radiopharmaceutical agents (eg, strontium-89) or investigational immunotherapy (eg, sipuleucel-T) within 12 weeks prior to the first dose of study drug

• Prior treatment with cytochrome 17 inhibitors (eg, abiraterone acetate, orteronel, galeterone, systemic ketoconazole)