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

Study Overview

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

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.

N/A

Advanced Solid Tumors
Solid Tumors
Ovarian Cancer
Breast Cancer
Prostate Cancer
NSCLC
Pancreatic Cancer
Colorectal Cancer

DRUG: TALZENNA capsule
DRUG: Talazoparib soft gel capsule
DRUG: Talazoparib soft gel capsule

C3441037
2020-006101-35 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-11-13	Results First Submitted 2022-12-12	Last Update Submitted that met QC Criteria 2024-06-06
First Submitted that Met QC Criteria 2020-12-11	Results First Submitted that Met QC Criteria 2024-06-06	Last Update Posted (ACTUAL) 2024-09-25
First Posted (ACTUAL) 2020-12-17	Results First Posted 2024-09-25	Last Verified 2024-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Crossover

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Sequence 1 Participants receive Treatment B for 28 days, followed by Treatment A for 21 days, followed by Treatment C for 21 days.	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
EXPERIMENTAL: Sequence 2 Participants receive Treatment A for 28 days, followed by Treatment B for 21 days, followed by Treatment C for 21 days.	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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Sequence 1

Participants receive Treatment B for 28 days, followed by Treatment A for 21 days, followed by Treatment C for 21 days.

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

EXPERIMENTAL: Sequence 2

Participants receive Treatment A for 28 days, followed by Treatment B for 21 days, followed by Treatment C for 21 days.

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

Primary Outcome Measures	Measure Description	Time Frame
Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fasted Conditions	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.	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.
Maximum Observed Plasma Concentration (Cmax) of Talazoparib After Multiple Dosing Under Fasted Conditions	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.	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.
Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fed Conditions	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.	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.
Maximum Observed Plasma Concentration (Cmax) of Talazoparib After Multiple Dosing Under Fed Conditions	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.	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.

Secondary Outcome Measures	Measure Description	Time Frame
Apparent Clearance After Oral Dose (CL/F) of Talazoparib After Multiple Dosing	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.	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.
Time of Observed Maximum Plasma Concentration (Tmax) of Talazoparib After Multiple Dosing	Tmax was defined as time to reach maximum observed plasma concentration.	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.
Area Under the Plasma Concentration-Time Profile From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of Talazoparib After Multiple Dosing	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.	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.
Predose Concentration During Multiple Dosing (Ctrough) of Talazoparib After Multiple Dosing	Ctrough was the pre-dose concentration during multiple dosing and was directly observed from data. The geometric coefficient of variation is expressed in percentage.	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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities)	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.	Day 1 up to 28 days after last dose of study drug (maximum up to 388 days)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Treatment Related)	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.	Day 1 up to 28 days after last dose of study drug (maximum up to 388 days)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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);

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Pfizer CT.gov Call Center, Pfizer

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record