A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors
Recruiting in Palo Alto (17 mi)
+44 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Pfizer
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial is testing a cancer drug called talazoparib in two forms: a pill and a new liquid-filled capsule. It targets patients with advanced solid tumors and works by preventing cancer cells from repairing their DNA.
Research Team
PC
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
Inclusion Criteria
Histological diagnosis of recurrent, locally advanced or metastatic solid tumor that is not amenable for treatment with curative intent.
Solid tumors with known or likely pathogenic germline or somatic tumor gene defect (eg, one or more BRCA1 or BRCA2 gene defect except for ovarian cancer) that would benefit from PARPi therapy per current approvals for the tumor indication or supported by strong scientific evidence.
Received at least 1 prior SOC regimen, if it exists, as appropriate for the respective tumor type unless deemed unsuitable or declined these therapies; ovarian cancer participants must have at least 1 prior cytotoxic chemotherapy regimen, including at least 1 course of platinum-based therapy. Participants must not have had disease progression within 6 months of initiation of platinum containing regimen.
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Treatment Details
Interventions
- Talazoparib (PARP Inhibitor)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Sequence 2Experimental Treatment2 Interventions
Participants receive Treatment A for 28 days, followed by Treatment B for 21 days, followed by Treatment C for 21 days.
Group II: Sequence 1Experimental Treatment2 Interventions
Participants receive Treatment B for 28 days, followed by Treatment A for 21 days, followed by Treatment C for 21 days.
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Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University