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
NCT ID: NCT04672460
Last Updated: 2024-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
73 participants
INTERVENTIONAL
2020-12-21
2022-07-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence 1
Participants receive Treatment B for 28 days, followed by Treatment A for 21 days, followed by Treatment C for 21 days.
TALZENNA capsule
Current commercial talazoparib formulation 1 mg once daily given under fasting condition
Talazoparib soft gel capsule
Proposed talazoparib soft gel capsule formulation 1 mg once daily under fasting condition
Talazoparib soft gel capsule
Proposed talazoparib soft gel capsule formulation 1 mg once daily under fed condition
Sequence 2
Participants receive Treatment A for 28 days, followed by Treatment B for 21 days, followed by Treatment C for 21 days.
TALZENNA capsule
Current commercial talazoparib formulation 1 mg once daily given under fasting condition
Talazoparib soft gel capsule
Proposed talazoparib soft gel capsule formulation 1 mg once daily under fasting condition
Talazoparib soft gel capsule
Proposed talazoparib soft gel capsule formulation 1 mg once daily under fed condition
Interventions
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TALZENNA capsule
Current commercial talazoparib formulation 1 mg once daily given under fasting condition
Talazoparib soft gel capsule
Proposed talazoparib soft gel capsule formulation 1 mg once daily under fasting condition
Talazoparib soft gel capsule
Proposed talazoparib soft gel capsule formulation 1 mg once daily under fed condition
Eligibility Criteria
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Inclusion Criteria
* 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.
2. ECOG performance score of 0-1.
3. Adequate bone marrow function:
* ANC ≥1500 cells/mm3
* Platelets ≥100,000 cells/mm3
* Hemoglobin ≥10.0 g/dL
4. Adequate organ functions:
* CLCR ≥60 mL/min and no documented CLCR \<60 mL/min and no change in CLCR \>25% in the past 4 weeks
* AST and ALT ≤2.5 × ULN; if liver function abnormalities are due to hepatic metastasis, then AST and ALT ≤5 × ULN;
* Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert's syndrome);
Exclusion Criteria
2. Toxicities from previous anti-cancer therapies must be resolved to NCI CTCAE \<Grade 2, except for alopecia, sensory neuropathies ≤Grade 2, or other Grade ≤2 AEs not constituting a safety risk, based on investigator's judgment, are acceptable.
3. Diagnosed with MDS or AML.
4. Active infection requiring systemic therapy within 2 weeks of enrollment.
5. Any condition in which active bleeding or pathological conditions may carry a high risk of bleeding (eg, known bleeding disorder, coagulopathy or tumor involvement with major vessels).
6. Known or suspected brain metastasis or active leptomeningeal disease undergoing or requiring treatment. Asymptomatic brain metastases currently not undergoing treatment are allowed.
7. Known history of testing positive for HIV, AIDS, positive HBV surface antigen, positive HCV RNA, or positive COVID-19 viral test. Asymptomatic patients with no active infection detected but positive antibody tests, indicating past infection, are allowed.
8. Current or anticipated use of P-gp inhibitors, BCRP inhibitors, and P-gp inducers within 2 weeks or 5 half-lives prior to randomization (whichever is longer) .
18 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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California Cancer Associates for Research and Excellence, Inc (cCARE)
Encinitas, California, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
California Cancer Associates for Research and Excellence, Inc (cCARE)
San Marcos, California, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, United States
Florida Cancer Specialists
Lake Mary, Florida, United States
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, United States
NYU Langone Hospital - Long Island Oncology
Mineola, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
NYU Investigational Pharmacy
New York, New York, United States
NYU Langone Medical Center (Tisch Hospital)
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
West Chester Hospital
West Chester, Ohio, United States
UPCI Investigational Drug Service
Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Upmc Shadyside
Pittsburgh, Pennsylvania, United States
Mary Crowley Cancer Research - Medical City Hospital
Dallas, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Liverpool Cancer Therapy Centre
Liverpool, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Epworth Healthcare (Epworth Freemasons Hospital)
East Melbourne, Victoria, Australia
Epworth Healthcare
East Melbourne, Victoria, Australia
Epworth Healthcare
Richmond, Victoria, Australia
Epworth Richmond Hospital (Epworth Healthcare)
Richmond, Victoria, Australia
Epworth Healthcare
East Melbourne, , Australia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2020-006101-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C3441037
Identifier Type: -
Identifier Source: org_study_id
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