Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments arn-509 (phase 1), arn-509 (phase 2)
Phase phase 1/phase 2
Target androgen receptor
Sponsor Aragon Pharmaceuticals, Inc.
Start date July 2010
End date August 2012
Trial size 17 participants
Trial identifier NCT01171898, ARN-509-001, CR103304

Summary

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
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.
arn-509 (phase 1)
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.
(Experimental)
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.
arn-509 (phase 2)
ARN-509 will be administered at Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), determined in Phase 1.
(Experimental)
Participants with treatment-naive metastatic CRPC will be enrolled. ARN-509 will be administered at MTD and/or RP2D, determined in Phase 1.
arn-509 (phase 2)
ARN-509 will be administered at Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), determined in Phase 1.
(Experimental)
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.
arn-509 (phase 2)
ARN-509 will be administered at Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), determined in Phase 1.

Primary Outcomes

Measure
PSA Response
time frame: 12 weeks

Secondary Outcomes

Measure
Time to PSA Progression
time frame: 12 weeks
Objective response rate, progression-free survival, metastasis-free survival (non-metastatic CRPC cohort)
time frame: 24 months
Safety and tolerability
time frame: 24 months
Circulating Tumor Cells (CTCs)
time frame: 24 months

Eligibility Criteria

Male participants at least 18 years old.

NON-METASTATIC CRPC Inclusion Criteria 1. Histologically or cytologically proven prostate cancer with high risk for development of metastases, defined as either a PSA value >=8 ng/mL within the last 3 months or PSA Doubling Time <=10 months 2. Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration) 3. Castrate levels of serum testosterone of less than or equal to 50 ng/dL 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 5. A life expectancy of at least 3 months Exclusion Criteria 1. Distant metastases, including CNS and vertebral or meningeal involvement 2. Prior treatment with MDV3100 3. Prior treatment with abiraterone 4. Prior treatment with ketoconazole 5. Concurrent treatment with medications known to have seizure potential 6. Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but will need to taper off as soon as possible. 7. QTc > 450 msec 8. History of seizure or condition that may predispose to seizure 9. Evidence of severe or uncontrolled systemic disease or HIV infection METASTATIC CRPC, TREATMENT-NAIVE Inclusion Criteria 1. Histologically or cytologically proven prostate cancer with progressive disease based on either PSA or radiographic progression 2. Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration) 3. Castrate levels of serum testosterone of less than or equal to 50 ng/dL 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 5. A life expectancy of at least 3 months Exclusion Criteria 1. History of, or current metastases in the brain or untreated spinal cord compression 2. Prior treatment with MDV3100 3. Prior treatment with abiraterone 4. Prior treatment with ketoconazole 5. Concurrent treatment with medications known to have seizure potential 6. Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but will need to taper off as soon as possible. 7. QTc > 450 msec 8. History of seizure or condition that may predispose to seizure 9. Evidence of severe or uncontrolled systemic disease or HIV infection METASTATIC CRPC, CHEMOTHERAPY-NAIVE, POST-ABIRATERONE Inclusion Criteria 1. Histologically or cytologically proven prostate cancer with progressive disease based on either PSA or radiographic progression 2. Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration) 3. Castrate levels of serum testosterone of less than or equal to 50 ng/dL 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 5. A life expectancy of at least 3 months 6. Patients must have received a minimum of 6 months of abiraterone treatment prior to disease progression Exclusion Criteria 1. History of, or current metastases in the brain or untreated spinal cord compression 2. Prior treatment with MDV3100 3. Prior treatment with ketoconazole 4. Concurrent treatment with medications known to have seizure potential 5. Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but will need to taper off as soon as possible. 6. QTc > 450 msec 7. History of seizure or condition that may predispose to seizure 8. Evidence of severe or uncontrolled systemic disease or HIV infection

Additional Information

Official title An Open-Label, Phase 1/2, Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 in Patients With Progressive Advanced Castration-Resistant Prostate Cancer
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Aragon Pharmaceuticals, Inc..