Pre-approval Single-patient Expanded Access for Talazoparib (PF-06944076)
Sponsor: Pfizer
ClinicalTrials ID:NCT05650476
This program offers pre-approval single-patient Expanded Access to talazoparib capsules for patients with metastatic castration-resistant prostate cancer. Treating physicians act as Sponsors and can submit requests via www.pfizercares.com. Availability is subject to location and country-specific regulations.
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Program Overview
Provide pre-approval single-patient Expanded Access (Compassionate Use) of talazoparib for patients with metastatic castration-resistant prostate cancer.
Description
In Expanded Access, treating physicians are the Sponsors..
Expanded Access requests from treating physicians may be submitted at www.pfizercares.com; availability will depend on location/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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