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Summary

for males ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

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

Keywords

Prostate Cancer Non-Metastatic Rising PSA Castration-Resistant Treatment-Naive Post-abiraterone Prostatic Neoplasms

Eligibility

For males ages 18 years and up

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

Locations

  • San Francisco, California, United States
  • San Diego, California, United States
  • Portland, Oregon, United States
  • Seattle, Washington, United States
  • Omaha, Nebraska, United States
  • Dallas, Texas, United States
  • Madison, Wisconsin, United States
  • Ann Arbor, Michigan, United States
  • Atlanta, Georgia, United States
  • Raleigh, North Carolina, United States
  • Myrtle Beach, South Carolina, United States
  • Towson, Maryland, United States
  • Baltimore, Maryland, United States
  • Lancaster, Pennsylvania, United States
  • New York, New York, United States
  • Boston, Massachusetts, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aragon Pharmaceuticals, Inc.
ID
NCT01171898
Phase
Phase 1/2
Lead Scientist
Charles Ryan
Study Type
Interventional
Last Updated
May 26, 2017