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Pre-approval Single-patient E...

Pre-approval Single-patient Expanded Access for Talazoparib (PF-06944076)

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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Provide pre-approval single-patient Expanded Access (Compassionate Use) of talazoparib for patients with metastatic castration-resistant prostate cancer.

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Detailed Description

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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.

Conditions

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Metastatic Castration-Resistant Prostate Cancer

Interventions

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Talazoparib

capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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).

Exclusion Criteria

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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers