Pre-approval Access to Talazoparib for Patients with Advanced Prostate Cancer
Sponsor: Pfizer
ClinicalTrials ID:NCT05650476
This program offers early access to the drug talazoparib for patients with advanced prostate cancer that has not responded to standard treatments. It is designed for individual patients who need this medication before it is officially approved.
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Program Overview
This program allows patients with advanced prostate cancer, specifically those whose cancer has continued to grow despite hormone therapy, to access the drug talazoparib before it is officially approved. This is known as Expanded Access or Compassionate Use, where a doctor can request the drug for a single patient who may benefit from it.
Description
In this Expanded Access program, doctors can request the drug talazoparib for their patients who have advanced prostate cancer that is resistant to hormone therapy. This program is intended for individual patients who need the drug before it is officially approved for general use. Doctors interested in obtaining talazoparib for their patients can submit a request through the Pfizer Cares website. The availability of the drug may vary depending on the patient's location or country.
Eligibility Criteria
Talazoparib is not intended for monotherapy. Talazoparib is intended for combination use with enzalutamide in first-line metastatic (M1) Castration-Resistant Prostate Cancer (mCRPC) only. Must be a newly diagnosed mCRPC patient who has not yet received 1st line therapy (1st generation Androgen Receptor (AR)-inhibitors do not count). Must have not received 2nd generation AR-inhibitors (enzalutamide, apalutamide, darolutamide), a Poly [ADP-ribose] polymerase (PARP)-inhibitor, cyclophosphamide, or mitoxantrone as prior treatments in any prostate cancer disease setting. Previous abiraterone and/or docetaxel for hormone-sensitive disease (CSPC) is allowed (patient eligible). Patients with identified need for use of potent P-glycoprotein (P-gp) inducer drugs within 7 days of onset/under duration of talazoparib plus enzalutamide treatment are at risk of drug-drug interactions (DDIs) and are therefore ineligible. Additional eligibility criteria may be required.
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