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8110 Gatehouse Road, Falls Church, VA 22042

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Talazoparib with Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (TALAPRO PF-06944076 C3441021)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT03395197

Background Information

This study will comprise 2 parts: Part 1 (which is now completed) and Part 2. The purpose of Part 1 was to identify the dose of talazoparib that can be given together with enzalutamide. The purpose of Part 2 is to determine whether the addition of talazoparib to enzalutamide provides additional benefit when compared to enzalutamide with placebo.

Talazoparib may stop the activity of certain specific proteins (called PARP1 and PARP2) that are found in all cells, normal and cancerous, and are involved in the repair of DNA. In clinical trials, the use of talazoparib and other compounds having a similar action have shown that these types of drugs can reduce tumor size and slow tumor growth. Early clinical studies show that enzalutamide blocks the repair of certain errors that may happen in the DNA when cells divide.

Principal Investigator

Inova Schar Cancer Institute
A department of Inova Fairfax Hospital
8081 Innovation Park Drive
Fairfax, VA 22031

Eligibility Information

  • Male Adults > 18 years of age
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell or signet cell features. If the patient does not have a prior histological diagnosis, a baseline de novo biopsy must be used to confirm the diagnosis and to support biomarker analysis
  • Asymptomatic or mildly symptomatic metastatic castration resistant prostate cancer (mCRPC) (score on BPI-SF Question #3 must be <4)
  • Additional eligibility in protocol

Ineligibility Information

  • Any prior systemic cancer treatment initiated in the non-metastatic CRPC and mCRPC disease state. This includes prior treatment with taxane-based chemotherapy or NHT of enzalutamide, apalutamide, or darolutamide initiated after onset of castration resistance setting.
  • Patients whose only evidence of metastasis is adenopathy below the aortic bifurcation.
  • Prior treatment with a PARP inhibitor, cyclophosphamide, or mitoxantrone for prostate cancer.'
  • Prior treatment with platinum-based chemotherapy within 6 months prior to Day 1 (Part 1) or randomization (Part 2), or any history of disease progression on platinum-based therapy at any time in the past.
  • Additional ineligibility in protocol

For more information, go to: https://clinicaltrials.gov/ct2/show/NCT03395197