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Trial Title:
Pre-approval Single-patient Expanded Access for Talazoparib (PF-06944076)
NCT ID:
NCT05650476
Condition:
Metastatic Castration-Resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Talazoparib
Conditions: Keywords:
Prostate Cancer
metastatic* Castration-Resistant Prostate Cancer (mCRPC)
enzalutamide
combination therapy
first-line mCRPC
metastatic (M1)
Study type:
Expanded Access
Overall status:
Available
Intervention:
Intervention type:
Drug
Intervention name:
Talazoparib
Description:
capsules
Summary:
Provide pre-approval single-patient Expanded Access (Compassionate Use) of talazoparib
for patients with metastatic castration-resistant prostate cancer.
Detailed 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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Source:
Pfizer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05650476
