NCT01695044 (Clinical Trial / PSMA ADC)

Study Title
A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC) (NCT01695044)

Trial Description
PSMA ADC 2301 is a Phase II, open-label, study to assess the anti-tumor activity and tolerability of 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). If a subject has received more than two cytotoxic chemotherapy regimens, sponsor approval is required for study participation.

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.

This trial is sponsored by Progenics Pharmaceuticals [1]

Study Data

  • Condition: Prostate Cancer
  • Interventions:
    • Drugs used in this trial
      • PSMA ADC
  • Phase: II
  • Enrollment: 119
  • Start: September 2012
  • Completion: February 2015
  • Last verified: March 2015

Study Schematic

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Last Editorial review: July 13, 2015
Information based on (NIH/NCI) and other sources.

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