Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A PHASE 1, OPEN LABEL, CROSSOVER STUDY TO ESTABLISH BIOEQUIVALENCE BETWEEN THE PROPOSED SOFT GEL TALAZOPARIB CAPSULE FORMULATION AND THE CURRENT TALAZOPARIB COMMERCIAL FORMULATION AND TO ESTIMATE THE FOOD EFFECT ON PHARMACOKINETICS OF THE PROPOSED TALAZOPARIB SOFT GEL CAPSULE FORMULATION IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Study ID: NCT04672460
Study Description
Brief Summary: This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft gel capsule) formulation after multiple dosing under fasting conditions in participants with advanced solid tumors. In addition, the effect of food on the PK of the proposed talazoparib soft gel capsule formulation will be evaluated in fixed sequence after the 2 BE assessment periods.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Montefiore Medical Center, Bronx, New York, 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
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center, Cleveland, 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
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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