Pre-approval Single-patient Expanded Access for Talazoparib... | Clinical Trial | StuddyBuddy@endsection Pre-approval Single-patient Expanded Access for Talazoparib (PF-06944076)
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Available NCT05650476

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

Conditions: Metastatic Castration-Resistant Prostate Cancer

Sex: Male
Ages: 18 Years – N/A
Sponsor: Pfizer

Summary

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

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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05650476). StuddyBuddy aggregates publicly available trial information.