Prostate Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

127

Study ID:

NCT01171898

Recruitment Status:

Active, not recruiting

Sponsor:

Aragon Pharmaceuticals, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You


San Diego California, , United States

San Francisco California, , United States

Atlanta Georgia, , United States

Baltimore Maryland, , United States

Boston Massachusetts, , United States

Ann Arbor Michigan, , United States

Omaha Nebraska, , United States

New York New York, , United States

Raleigh North Carolina, , United States

Portland Oregon, , United States

Lancaster Pennsylvania, , United States

Myrtle Beach South Carolina, , United States

Dallas Texas, , United States

Seattle Washington, , United States

Madison Wisconsin, , United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

127

Study ID:

NCT01171898

Recruitment Status:

Active, not recruiting

Sponsor:


Aragon Pharmaceuticals, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.