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Brief Title: A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Official Title: A Phase 2, Open-label, Multicenter Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer
Study ID: NCT01695044
Brief Summary: PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in two groups of subjects with metastatic castration-resistant prostate cancer (mCRPC). One group comprises subjects who must have received at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). The second group comprises subjects who are cytotoxic chemotherapy-naïve. Subjects who are cytotoxic chemotherapy-naïve must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223. Both groups of subjects must also have received and progressed on abiraterone acetate and/or enzalutamide. If a subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study. Subjects will receive up to eight doses of PSMA ADC approximately once every three weeks.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
, Birmingham, Alabama, United States
, Tucson, Arizona, United States
, Burbank, California, United States
, Encinitas, California, United States
, Los Angeles, California, United States
, San Diego, California, United States
, Denver, Colorado, United States
, New Haven, Connecticut, United States
, Norwalk, Connecticut, United States
, Port St. Lucie, Florida, United States
, Honolulu, Hawaii, United States
, Fairway, Kansas, United States
, New Orleans, Louisiana, United States
, Baltimore, Maryland, United States
, Baltimore, Maryland, United States
, Rockville, Maryland, United States
, Boston, Massachusetts, United States
, Ann Arbor, Michigan, United States
, Rochester, Minnesota, United States
, Omaha, Nebraska, United States
, Las Vegas, Nevada, United States
, Lake Success, New York, United States
, New York, New York, United States
, Rochester, New York, United States
, Stony Brook, New York, United States
, Huntersville, North Carolina, United States
, Raleigh, North Carolina, United States
, Cleveland, Ohio, United States
, Pittsburgh, Pennsylvania, United States
, Providence, Rhode Island, United States
, Greenville, South Carolina, United States
, Myrtle Beach, South Carolina, United States
, Memphis, Tennessee, United States
, Dallas, Texas, United States
, Norfolk, Virginia, United States
, Seattle, Washington, United States
Name: Vivien Wong, PhD
Affiliation: Progenics Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR