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
- Conditions
- Advanced Solid TumorsBreast CancerPancreatic CancerSolid TumorsOvarian CancerProstate CancerColorectal CancerNSCLC
- Interventions
- Registration Number
- NCT04672460
- Lead Sponsor
- Pfizer
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 Talazoparib soft gel capsule Participants receive Treatment B for 28 days, followed by Treatment A for 21 days, followed by Treatment C for 21 days. Sequence 2 Talazoparib soft gel capsule Participants receive Treatment A for 28 days, followed by Treatment B for 21 days, followed by Treatment C for 21 days. Sequence 2 TALZENNA capsule Participants receive Treatment A for 28 days, followed by Treatment B for 21 days, followed by Treatment C for 21 days. Sequence 1 TALZENNA capsule Participants receive Treatment B for 28 days, followed by Treatment A for 21 days, followed by Treatment C for 21 days.
- Primary Outcome Measures
Name Time Method Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fasted Conditions Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively. AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI were expressed as percentages.
Maximum Observed Plasma Concentration (Cmax) of Talazoparib After Multiple Dosing Under Fasted Conditions Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively. Cmax was the maximum observed plasma concentration and was directly observed from data. The geometric coefficient of variation was expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI were expressed as percentages.
Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fed Conditions Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively. AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI were expressed as percentages.
Maximum Observed Plasma Concentration (Cmax) of Talazoparib After Multiple Dosing Under Fed Conditions Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively. Cmax was the maximum observed plasma concentration and was directly observed from data. The geometric coefficient of variation was expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI were expressed as percentages.
- Secondary Outcome Measures
Name Time Method Apparent Clearance After Oral Dose (CL/F) of Talazoparib After Multiple Dosing Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively. Apparent Clearance After Oral Dose (CL/F) was defined as apparent clearance after oral dose on the last day of treatment period. The geometric coefficient of variation is expressed in percentage.
Time of Observed Maximum Plasma Concentration (Tmax) of Talazoparib After Multiple Dosing Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively. Tmax was defined as time to reach maximum observed plasma concentration.
Area Under the Plasma Concentration-Time Profile From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of Talazoparib After Multiple Dosing Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively. AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation was expressed in percentage.
Predose Concentration During Multiple Dosing (Ctrough) of Talazoparib After Multiple Dosing Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2, predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively. Ctrough was the pre-dose concentration during multiple dosing and was directly observed from data. The geometric coefficient of variation is expressed in percentage.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities) Day 1 up to 28 days after last dose of study drug (maximum up to 388 days) An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent adverse event (TEAE) means event between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of death; inpatient hospitalization; life-threatening experience; disability; congenital anomaly or deemed significant for any other reason.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Treatment Related) Day 1 up to 28 days after last dose of study drug (maximum up to 388 days) An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent adverse event (TEAE) means event between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of death; inpatient hospitalization; life-threatening experience; disability; congenital anomaly or deemed significant for any other reason.
Trial Locations
- Locations (28)
Mary Crowley Cancer Research - Medical City Hospital
🇺🇸Dallas, Texas, United States
West Chester Hospital
🇺🇸West Chester, Ohio, United States
California Cancer Associates for Research and Excellence, Inc (cCARE)
🇺🇸San Marcos, 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
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
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, Australia
Epworth Richmond Hospital (Epworth Healthcare)
🇦🇺Richmond, Victoria, Australia