Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 in Castration-Resistant Prostate Cancer (CRPC)
This study is ongoing, but not recruiting participants.
Sponsor:
Aragon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Aragon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01171898
First received: July 27, 2010
Last updated: October 9, 2012
Last verified: October 2012
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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 1 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: | 123 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (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
- 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
- Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration)
- Castrate levels of serum testosterone of less than or equal to 50 ng/dL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- A life expectancy of at least 3 months
Exclusion Criteria
- Distant metastases, including CNS and vertebral or meningeal involvement
- Prior treatment with MDV3100
- Prior treatment with abiraterone
- Prior treatment with ketoconazole
- Concurrent treatment with medications known to have seizure potential
- 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.
- QTc > 450 msec
- History of seizure or condition that may predispose to seizure
- Evidence of severe or uncontrolled systemic disease or HIV infection
METASTATIC CRPC, TREATMENT-NAIVE
Inclusion Criteria
- Histologically or cytologically proven prostate cancer with progressive disease based on either PSA or radiographic progression
- Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration)
- Castrate levels of serum testosterone of less than or equal to 50 ng/dL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- A life expectancy of at least 3 months
Exclusion Criteria
- History of, or current metastases in the brain or untreated spinal cord compression
- Prior treatment with MDV3100
- Prior treatment with abiraterone
- Prior treatment with ketoconazole
- Concurrent treatment with medications known to have seizure potential
- 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.
- QTc > 450 msec
- History of seizure or condition that may predispose to seizure
- Evidence of severe or uncontrolled systemic disease or HIV infection
METASTATIC CRPC, CHEMOTHERAPY-NAIVE, POST-ABIRATERONE
Inclusion Criteria
- Histologically or cytologically proven prostate cancer with progressive disease based on either PSA or radiographic progression
- Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration)
- Castrate levels of serum testosterone of less than or equal to 50 ng/dL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- A life expectancy of at least 3 months
- Patients must have received a minimum of 6 months of abiraterone treatment prior to disease progression
Exclusion Criteria
- History of, or current metastases in the brain or untreated spinal cord compression
- Prior treatment with MDV3100
- Prior treatment with ketoconazole
- Concurrent treatment with medications known to have seizure potential
- 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.
- QTc > 450 msec
- History of seizure or condition that may predispose to seizure
- Evidence of severe or uncontrolled systemic disease or HIV infection
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171898
Locations
| United States, California | |
| Sharp Memorial Hospital | |
| San Diego, California, United States, 92123 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Georgia | |
| Georgia Cancer Specialists | |
| Atlanta, Georgia, United States, 30341 | |
| United States, Maryland | |
| The Sidney Kommel Comprehensive Cancer at Johns Hopkins | |
| Baltimore, Maryland, United States, 21205 | |
| Chesapeake Urology Research Associates | |
| Baltimore, Maryland, United States, 21204 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| University of Michigan Health System | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Nebraska | |
| Nebraska Cancer Specialists | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| Cancer Centers of North Carolina | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Oregon | |
| Oregon Health Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Urological Associates | |
| Lancaster, Pennsylvania, United States, 17604 | |
| United States, South Carolina | |
| Carolina Urologic Research Center | |
| Myrtle Beach, South Carolina, United States, 29572 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| United States, Washington | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109 | |
| United States, Wisconsin | |
| University of Wisconsin Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
Sponsors and Collaborators
Aragon Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | Dana Rathkopf, MD | Memorial Sloan-Kettering Cancer Center |
| Study Director: | Edna Chow Maneval, PhD | Aragon Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Aragon Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01171898 History of Changes |
| Other Study ID Numbers: | ARN-509-001 |
| Study First Received: | July 27, 2010 |
| Last Updated: | October 9, 2012 |
| 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 October 17, 2012
