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

PHASE1CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

December 21, 2020

Primary Completion Date

February 4, 2022

Study Completion Date

July 22, 2022

Conditions
Advanced Solid TumorsSolid TumorsOvarian CancerBreast CancerProstate CancerNSCLCPancreatic CancerColorectal Cancer
Interventions
DRUG

TALZENNA capsule

Current commercial talazoparib formulation 1 mg once daily given under fasting condition

DRUG

Talazoparib soft gel capsule

Proposed talazoparib soft gel capsule formulation 1 mg once daily under fasting condition

DRUG

Talazoparib soft gel capsule

Proposed talazoparib soft gel capsule formulation 1 mg once daily under fed condition

Trial Locations (31)

2170

Liverpool Cancer Therapy Centre, Liverpool

Liverpool Hospital, Liverpool

3002

Epworth Healthcare (Epworth Freemasons Hospital), East Melbourne

Epworth Healthcare, East Melbourne

Epworth Healthcare, East Melbourne

3121

Epworth Healthcare, Richmond

Epworth Richmond Hospital (Epworth Healthcare), Richmond

3168

Monash Health, Clayton

10016

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York

NYU Investigational Pharmacy, New York

NYU Langone Medical Center (Tisch Hospital), New York

10461

Montefiore Medical Center, The Bronx

11501

NYU Langone Hospital - Long Island Oncology, Mineola

NYU Langone Hospital - Long Island, Mineola

15232

UPCI Investigational Drug Service, Pittsburgh

UPMC Hillman Cancer Center, Pittsburgh

Upmc Shadyside, Pittsburgh

32746

Florida Cancer Specialists, Lake Mary

44106

University Hospitals Cleveland Medical Center, Cleveland

45069

West Chester Hospital, West Chester

45219

University of Cincinnati Medical Center, Cincinnati

64114

Alliance for Multispecialty Research, LLC, Kansas City

75230

Mary Crowley Cancer Research - Medical City Hospital, Dallas

78229

NEXT Oncology, San Antonio

90048

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles

Cedars-Sinai Medical Center, Los Angeles

92024

California Cancer Associates for Research and Excellence, Inc (cCARE), Encinitas

92069

California Cancer Associates for Research and Excellence, Inc (cCARE), San Marcos

06510

Smilow Cancer Hospital at Yale New Haven, New Haven

Yale-New Haven Hospital, New Haven

06511

Smilow Cancer Hospital Phase 1 Unit, New Haven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT04672460 - 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 | Biotech Hunter | Biotech Hunter