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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 7 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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.
Find a Location
Who is running the clinical trial?
Aragon Pharmaceuticals, Inc.Lead Sponsor
16 Previous Clinical Trials
5,247 Total Patients Enrolled
4 Trials studying Prostate Cancer
1,157 Patients Enrolled for Prostate Cancer
Aragon Pharmaceuticals, Inc Clinical TrialStudy DirectorAragon Pharmaceuticals, Inc.
2 Previous Clinical Trials
96 Total Patients Enrolled
2 Trials studying Prostate Cancer
96 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My prostate cancer is at high risk of spreading, with a recent PSA >=8 or it doubles in <=10 months.I am currently on hormone therapy for cancer or have had an orchiectomy.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.I am currently taking steroids but can stop if needed.I have a history of seizures or a condition that could lead to seizures.I am currently taking medication that could cause seizures.I have previously been treated with MDV3100.My testosterone levels are very low.I do not have severe or uncontrolled diseases or HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Non-metastatic CRPC (Phase 2)
- Group 2: Treatment-naive metastatic CRPC (Phase 2)
- Group 3: Post-abiraterone metastatic CRPC (Phase 2)
- Group 4: Dose Escalation Cohort (Phase 1)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
From how many respective research facilities is this study being overseen?
"Presently, this clinical trial is looking for participants from a total of 15 sites. Some of these sites are situated in Seattle, Atlanta and Lancaster. If you are thinking about participating in this trial, try to select a location near you to limit travel."
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