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Antiandrogen

Apalutamide for Prostate Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Aragon Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration)

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Must not have

Distant metastases, including CNS and vertebral or meningeal involvement

Prior treatment with abiraterone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 7 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, ARN-509, for safety and effectiveness in men with prostate cancer that has progressed despite hormone therapy. Patients will be enrolled in two phases, with the first phase used to find a safe dose for the second phase.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Specific side effects aren't listed here but generally could include typical reactions from cancer medications such as fatigue, nausea, risk of infections due to lowered immunity, potential liver function changes and possibly seizures given the exclusion criteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently on hormone therapy for cancer or have had an orchiectomy.

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I am fully active or can carry out light work.

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

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

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My testosterone levels are very low.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been treated with abiraterone before.

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I have been treated with ketoconazole before.

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I have a history of seizures or a condition that could lead to seizures.

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I am currently taking medication that could cause seizures.

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I have previously been treated with MDV3100.

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I do not have severe or uncontrolled diseases or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1 and 2: Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) at Week 12

Secondary study objectives

Phase 1 and 2: Median Time to PSA Progression

Phase 1 and 2: Objective Response Rate

Phase 1 and 2: Progression-free Survival (PFS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 12Eligibility criteria met