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NCT05650476 Clinical Trial

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

Metastatic Castration-Resistant Prostate Cancer Clinical Trial

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05650476
Other study ID # C344
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date September 2023
Source Pfizer
Contact Pfizer Cares
Email PfizerCares@pfizer.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Talazoparib
capsules

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer
See also
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