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A Multicenter, Randomized, Controlled Phase 2 Study: Efficacy and Safety of I-131-1095 Radiotherapy in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Who Are 18F-DCFPyL Prostate-specific Membrane Antigen (PSMA)-Avid, Chemotherapy-naive, and Progressed on Abiraterone

Trial Profile

A Multicenter, Randomized, Controlled Phase 2 Study: Efficacy and Safety of I-131-1095 Radiotherapy in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Who Are 18F-DCFPyL Prostate-specific Membrane Antigen (PSMA)-Avid, Chemotherapy-naive, and Progressed on Abiraterone

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 20 Nov 2019

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At a glance

  • Drugs Enzalutamide (Primary) ; MIP 1095-I-131 (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Therapeutic Use
  • Acronyms ARROW
  • Sponsors Progenics Pharmaceuticals
  • Most Recent Events

    • 07 Nov 2019 According to a Progenics Pharmaceuticals media release, patients are being dosed at Canadian sites. CPDC has not been allowed to ship drug to the U.S. under an import alert. Following lifting of the import ban by the FDA, company will submit a request to utilize the CPDC drug at U.S. sites. Company expect that review of request will be completed by the end of 2019, and initiation of dosing at U.S. clinical sites is expected to begin in the first quarter of 2020.
    • 09 Aug 2019 According to an Progenics Pharmaceuticals media release, based on the early data emerging from this trial and dialogue with the FDA, the company plans to initiate a pivotal trial of 1095 in 2020.
    • 13 Jun 2019 According to a Progenics Pharmaceuticals media release, the patients will be followed for one year after their first treatment for all efficacy endpoints. Survival and safety data will be collected for an additional year.
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