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MDV3100 Expanded Access Program for Use in Metastatic Prostate Cancer Patients

June 1, 2012 -- The investigational therapy MDV3100 (Enzalutamide) has been cleared to proceed with an Expanded Access Program (EAP) for treatment-resistant metastatic prostate cancer patients previously treated with docetaxel chemotherapy. This EAP program is designed to bring potential new medications to the most advanced prostate cancer patients after successful Phase III clinical trials and before a final drug approval by the Food and Drug Administration (FDA).

Medivation and Astellas, the manufactures of MDV3100, applied for a New Drug Application with the FDA in early May 2012.

The research and development period for MDV3100 has been a comparatively short nine years. PCF’s total investment of $14.75 million in MDV3100 was also supported by the PCF’s investment in the Prostate Cancer Clinical Trials Consortium.

The EAP has provided the following criteria and center locations for MDV3100 participation:

Basic Eligibility Criteria:

  • CRPC/HRPC - on hormone therapy with progressive disease
  • Metastatic
  • NO small cell or neuroendocrine features
  • Previously treated with Taxotere (docetaxel)
  • No brain metastases
  • HGB 9.0 or higher
  • No history of stroke or seizure
  • No significant cardiovascular disease

If you think you fit the above criteria, contact one of the sites below for further criteria and screening:

Alaska Clinical Research Center, LLC
Contact:  Robin Adams  (907) 276-1455
Anchorage, Alaska 99508

Pinnacle Oncology/Hematology
Contact: Sherril Bierman (480) 278-8804
Scottsdale, AZ  85258

Prostate Oncology Specialists
Contact:  Jennifer Leung  (310) 827-7707
Marina Del Rey, CA 90292
Dr Ronald Yanagihara
Contact: Katrina or Lara (408) 847-6194
Gilroy, CA 95020

Investigative Clinical Research of Indiana LLC
Contact:  Leslie Weitman (317) 716-0323 
Indianapolis, IN, 46260

Jackson Oncology Associates, PLLC
Contact:  Teresa Davis (601) 974-5547
Jackson, Mississippi, 39202

New Hampshire
New Hampshire Oncology Hematology PA
Contact:  Margaret White (603) 224-2556 x 1323 
Hooksett, New Hampshire, 03106

New York
Accumed Research Associates
Contact:  Tammi Allegra (516) 746-2190
Garden City, New York, 11530

North Carolina
Cancer Centers of North Carolina
Contact: Julia Berry (919) 781-7070
Raleigh, North Carolina, 27607

South Carolina
Charleston Hematology Oncology Associates, PA
Contact:  Deborah McNeal (843) 266-2540
Charleston, South Carolina, 29414

Carolina Urologic Research Center
Contact:  Tabitha Joyner (843) 449-1010 x228 
Myrtle Beach, South Carolina, 29572

Virginia Oncology Associates
Contact: Wendi Gobhardt (757) 213-5813
Norfolk, VA, 23502 

For general information, please contact:
Jan Manarite
Early/Expanded Access Committee
PCRI Senior Educational Facilitator
(239) 395-0995 Direct

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