Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 in Castration-Resistant Prostate Cancer (CRPC)

This study is currently recruiting participants.
Verified January 2014 by Aragon Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Aragon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01171898
First received: July 27, 2010
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: ARN-509
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Aragon Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • PSA Response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The percentage of patients reaching at least a 50% reduction in PSA as compared to baseline at 12 weeks


Secondary Outcome Measures:
  • Time to PSA Progression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Median time to PSA progression will be determined as the time from the start of treatment until the criteria for PSA progression are met

  • Objective response rate, progression-free survival, metastasis-free survival (non-metastatic CRPC cohort) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Radiographic progression will be evaluated in all patients

  • Safety and tolerability [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities will be evaluated

  • Circulating Tumor Cells (CTCs) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Exploratory analyses of pre- and post-therapy changes in CTC number and molecular profiling


Estimated Enrollment: 127
Study Start Date: July 2010
Estimated Study Completion Date: September 2014
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 2 Non-metastatic CRPC
50 patients with non-metastatic, treatment-naive CRPC with rapidly rising PSA
Drug: ARN-509
Androgen receptor antagonist
Experimental: Phase 2 Treatment-naive metastatic CRPC
20 patients with treatment-naive metastatic CRPC
Drug: ARN-509
Androgen receptor antagonist
Experimental: Phase 2 Post-abiraterone metastatic CRPC
20 patients with metastatic CRPC that are chemotherapy-naive, but have been previously treated with abiraterone
Drug: ARN-509
Androgen receptor antagonist

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171898

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
United States, California
Active, not recruiting
San Diego, California, United States
Active, not recruiting
San Francisco, California, United States
United States, Georgia
Active, not recruiting
Altanta, Georgia, United States
United States, Maryland
Active, not recruiting
Baltimore, Maryland, United States
Active, not recruiting
Towson, Maryland, United States
United States, Massachusetts
Active, not recruiting
Boston, Massachusetts, United States
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States
United States, Nebraska
Active, not recruiting
Omaha, Nebraska, United States
United States, New York
Active, not recruiting
New York, New York, United States
United States, North Carolina
Active, not recruiting
Raleigh, North Carolina, United States
United States, Oregon
Active, not recruiting
Portland, Oregon, United States
United States, Pennsylvania
Active, not recruiting
Lancaster, Pennsylvania, United States
United States, South Carolina
Active, not recruiting
Myrtle Beach, South Carolina, United States
United States, Texas
Recruiting
Dallas, Texas, United States
United States, Washington
Active, not recruiting
Seattle, Washington, United States
United States, Wisconsin
Active, not recruiting
Madison, Wisconsin, United States
Sponsors and Collaborators
Aragon Pharmaceuticals, Inc.
Investigators
Study Director: Aragon Pharmaceuticals, Inc Clinical Trial Aragon Pharmaceuticals, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Aragon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01171898     History of Changes
Other Study ID Numbers: CR103304, ARN-509-001
Study First Received: July 27, 2010
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aragon Pharmaceuticals, Inc.:
Non-Metastatic
Rising PSA
Castration-Resistant
Treatment-Naive
Post-abiraterone

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgen Receptor Antagonists
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014