Apalutamide for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Aragon Pharmaceuticals, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the safety and activity of ARN-509 in men with advanced castration resistant prostate cancer. Patients will first be enrolled into Phase 1 of the study to identify a tolerable dose for the Phase 2 portion of the study. In the Phase 2, 3 different cohorts of patients will be enrolled to evaluate the safety and activity of ARN-509.

Research Team

Aragon Pharmaceuticals, Inc Clinical Trial

Principal Investigator

Aragon Pharmaceuticals, Inc.

Eligibility Criteria

Men with advanced prostate cancer that hasn't spread far, who are on hormone therapy or have had surgery to lower testosterone levels. They should have a rising PSA level or a fast-doubling time for PSA, be fairly active (ECOG 0-1), and expected to live at least 3 more months. Men can't join if they've taken certain drugs like MDV3100 or ketoconazole, have heart issues (QTc > 450 msec), uncontrolled diseases, HIV, brain metastases, been treated with abiraterone, or have seizure risks.

Inclusion Criteria

I have been treated with abiraterone for at least 6 months before my disease got worse.

I am fully active or can carry out light work.

My prostate cancer is worsening, shown by tests or scans.

See 4 more

Exclusion Criteria

My cancer has spread to distant parts of my body, including the brain or spine.

I have been treated with abiraterone before.

I have been treated with ketoconazole before.

See 6 more

Treatment Details

Interventions

ARN-509 (Antiandrogen)

Trial OverviewThe trial is testing ARN-509's safety and effectiveness in two phases for castration-resistant prostate cancer. Phase 1 finds the right dose; Phase 2 tests this dose further in different groups of patients to see how well it works and monitors safety.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Treatment-naive metastatic CRPC (Phase 2)Experimental Treatment1 Intervention

Participants with treatment-naive metastatic CRPC will be enrolled. ARN-509 will be administered at MTD and/or RP2D, determined in Phase 1.

Group II: Post-abiraterone metastatic CRPC (Phase 2)Experimental Treatment1 Intervention

Participants with metastatic CRPC that are chemotherapy-naive, but have been previously treated with abiraterone will be enrolled. ARN-509 will be administered at MTD and/or RP2D, determined in Phase 1.

Group III: Non-metastatic CRPC (Phase 2)Experimental Treatment1 Intervention

Participants with non-metastatic, treatment-naive Castration-Resistant Prostate Cancer (CRPC) with rapidly rising Prostate Specific Antigen (PSA) will be enrolled. ARN-509 will be administered at Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), determined in Phase 1.

Group IV: Dose Escalation Cohort (Phase 1)Experimental Treatment1 Intervention

ARN-509 will be administered at a starting dose of 30 milligram per day (mg/day), with escalations to 60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg, 390 mg, and 480 mg daily. Once Recommended Phase 2 Dose (RP2D) has been selected, Phase 1 participants being treated at the lower dose levels will be allowed to escalate to the RP2D level at the discretion of the primary investigator.