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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

PSA Response

Outcome Description:

The percentage of patients reaching at least a 50% reduction in PSA as compared to baseline at 12 weeks

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Dana Rathkopf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ARN-509-001

NCT ID:

NCT01171898

Start Date:

July 2010

Completion Date:

June 2013

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Baylor University Medical CenterDallas, Texas  75246
Georgia Cancer SpecialistsDecatur, Georgia  30033
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Seattle Cancer Care AllianceSeattle, Washington  98109
Sharp Memorial HospitalSan Diego, California  92123
Oregon Health Science UniversityPortland, Oregon  97239
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
University of Wisconsin Cancer CenterMadison, Wisconsin  53792
University of Michigan Health SystemAnn Arbor, Michigan  
Cancer Centers of North CarolinaRaleigh, North Carolina  27607
Chesapeake Urology Research AssociatesTowson, Maryland  21204
Nebraska Cancer SpecialistsOmaha, Nebraska  68114
The Sidney Kommel Comprehensive Cancer at Johns HopkinsBaltimore, Maryland  21205
Urological AssociatesLancaster, Pennsylvania  17604