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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-006101-35 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Participants receive Treatment B for 28 days, followed by Treatment A for 21 days, followed by Treatment C for 21 days. |
|
| Sequence 2 | Experimental | Participants receive Treatment A for 28 days, followed by Treatment B for 21 days, followed by Treatment C for 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TALZENNA capsule | Drug | Current commercial talazoparib formulation 1 mg once daily given under fasting condition |
|
| 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. |
| 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. |
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Inclusion Criteria
Histological diagnosis of recurrent, locally advanced or metastatic solid tumor that is not amenable for treatment with curative intent.
ECOG performance score of 0-1.
Adequate bone marrow function:
Adequate organ functions:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Cancer Associates for Research and Excellence, Inc (cCARE) | Encinitas | California | 92024 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41379622 | Derived | Wang D, Guo CC, Gao X, Wang Y, Yu Y, Plotka A, Elmeliegy M, Shi H, Johnson S, DeAnnuntis L, Hoffman J. Talazoparib Formulation Bridging in Cancer Patients-Challenges and the Critical Role of Model-Informed Drug Development in Approval Despite Failed Bioequivalence. CPT Pharmacometrics Syst Pharmacol. 2026 Jan;15(1):e70157. doi: 10.1002/psp4.70157. Epub 2025 Dec 11. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 73 participants were assigned to study treatment, and all of them were permanently discontinued from study treatment. Fifty-two participants entered the safety follow-up phase and 46 of them completed the safety follow-up.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Participants were randomly assigned to sequence BAC. Participants received treatment B: talazoparib soft gel capsule formulation 1 mg once daily given under fasting condition in Period 1 for 28 days followed by Treatment A: current commercial talazoparib formulation 1 mg once daily given under fasting condition in Period 2 for 21 days. Participants received Treatment C: talazoparib soft gelatin capsule formulation 1 mg once daily given with food in Period 3 (food effect assessment) for 21 days. Participants who required a dose reduction, had unstable renal function, experienced renal function worsening to moderate/severe renal impairment during the study, or completed the food effect assessment, were enrolled over to the maintenance phase which consisted of repeating 28- day cycles of treatment with the current commercial talazoparib formulation 1 mg once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Bioequivalence Phase: Period 1 (28 Days) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2021 | Dec 12, 2022 |
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Participants will be randomly assigned to 1 of 2 sequences to receive Treatment A, B and C in different order as shown below. The first 2 periods will be for BE assessment, with the first period being 28 days and the following periods being 21 days. Period 3 will be a 21 day period to evaluate the food effect on the PK of the proposed talazoparib soft gel capsule formulation that will be included in the fixed sequence after the 2 BE assessment periods (for participants who can tolerate one high-fat/high-calorie meal). Participants must have received 21 consecutive days of continuous 1mg QD drug administration to be considered as completers of a treatment period, before moving on to the next scheduled treatment.
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| Talazoparib soft gel capsule | Drug | Proposed talazoparib soft gel capsule formulation 1 mg once daily under fasting condition |
|
| Talazoparib soft gel capsule | Drug | Proposed talazoparib soft gel capsule formulation 1 mg once daily under fed condition |
|
| 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) |
| Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute |
| Los Angeles |
| California |
| 90048 |
| United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| California Cancer Associates for Research and Excellence, Inc (cCARE) | San Marcos | California | 92069 | United States |
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | 06510 | United States |
| Yale-New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| Smilow Cancer Hospital Phase 1 Unit | New Haven | Connecticut | 06511 | United States |
| Florida Cancer Specialists | Lake Mary | Florida | 32746 | United States |
| Alliance for Multispecialty Research, LLC | Kansas City | Missouri | 64114 | United States |
| NYU Langone Hospital - Long Island Oncology | Mineola | New York | 11501 | United States |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | United States |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | 10016 | United States |
| NYU Investigational Pharmacy | New York | New York | 10016 | United States |
| NYU Langone Medical Center (Tisch Hospital) | New York | New York | 10016 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| West Chester Hospital | West Chester | Ohio | 45069 | United States |
| UPCI Investigational Drug Service | Pittsburgh | Pennsylvania | 15232 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Upmc Shadyside | Pittsburgh | Pennsylvania | 15232 | United States |
| Mary Crowley Cancer Research - Medical City Hospital | Dallas | Texas | 75230 | United States |
| NEXT Oncology | San Antonio | Texas | 78229 | United States |
| Liverpool Cancer Therapy Centre | Liverpool | New South Wales | 2170 | Australia |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Epworth Healthcare (Epworth Freemasons Hospital) | East Melbourne | Victoria | 3002 | Australia |
| Epworth Healthcare | East Melbourne | Victoria | 3002 | Australia |
| Epworth Healthcare | Richmond | Victoria | 3121 | Australia |
| Epworth Richmond Hospital (Epworth Healthcare) | Richmond | Victoria | 3121 | Australia |
| Epworth Healthcare | East Melbourne | 3002 | Australia |
| FG001 | Sequence 2 | Participants were randomly assigned to sequence ABC. Participants received treatment A: current commercial talazoparib formulation 1 mg once daily given under fasting condition in Period 1 for 28 days followed by Treatment B: talazoparib soft gel capsule formulation 1 mg once daily given under fasting condition in Period 2 for 21 days. Participants received Treatment C: talazoparib soft gelatin capsule formulation 1 mg once daily given with food in Period 3 (food effect assessment) for 21 days. Participants who required a dose reduction, had unstable renal function, experienced renal function worsening to moderate/severe renal impairment during the study, or completed the food effect assessment, were enrolled over to the maintenance phase which consisted of repeating 28- day cycles of treatment with the current commercial talazoparib formulation 1 mg once daily. |
| COMPLETED |
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| NOT COMPLETED |
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| Bioequivalence Phase: Period 2 (21 Days) |
|
|
| Food Effect Phase: Period 3 (21 Days) |
|
|
| Maintenance Phase: Period 4 (28 Days) |
|
|
All enrolled participants who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants were randomly assigned to 1 of 2 sequences to receive treatments A, B and C in different order with 3 periods. The first 2 periods were for BE assessment with treatment A and B (Period 1 was 28 days and Period 2 was 21 days); Period 3 was a 21-day period to evaluate the food effect with treatment C. Sequence 1 (Period 1: Treatment B; Period 2: Treatment A; Period 3: Treatment C); Sequence 2 (Period 1: Treatment A; Period 2: Treatment B; Period 3: Treatment C); Treatment A: current commercial talazoparib formulation 1 mg once daily given under fasting condition (reference for BE evaluation); Treatment B: the proposed talazoparib soft gel capsule formulation 1 mg once daily given under fasting condition (test for BE evaluation, reference for food effect evaluation); Treatment C: the proposed talazoparib soft gelatin capsule formulation 1 mg once daily given with food (on the PK sampling day, high-fat/high-calorie meal was administered in the clinical sites prior to the administration of the proposed talazoparib soft gelatin capsule formulation; test for food-effect evaluation). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis population was defined as all participants randomized and treated who had primary PK parameter of AUC24 or Cmax in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/millilitre (ng*hr/mL) | 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. |
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| Primary | 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. | The analysis population was defined as all participants randomized and treated who had primary PK parameter of AUC24 or Cmax in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/millilitre (ng/mL) | 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. |
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| Primary | 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. | The analysis population was defined as all participants randomized and treated who had primary PK parameter of AUC24 or Cmax in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 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. |
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| Primary | 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. | The analysis population was defined as all participants randomized and treated who had primary PK parameter of AUC24 or Cmax in at least 1 treatment period. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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. |
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| Secondary | 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. | The analysis population was defined as all participants randomized and treated who had primary PK parameter of AUC24 or Cmax in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter per hour (L/hr) | 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. |
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| Secondary | Time of Observed Maximum Plasma Concentration (Tmax) of Talazoparib After Multiple Dosing | Tmax was defined as time to reach maximum observed plasma concentration. | The analysis population was defined as all participants randomized and treated who had primary PK parameter of AUC24 or Cmax in at least 1 treatment period. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Median | Full Range | hour | 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. |
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| Secondary | 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. | The analysis population was defined as all participants randomized and treated who had primary PK parameter of AUC24 or Cmax in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 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. |
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| Secondary | 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. | The analysis population was defined as all participants randomized and treated who had primary PK parameter of AUC24 or Cmax in at least 1 treatment period. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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. |
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| Secondary | 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. | Population analysis set included all participants randomly assigned to investigational product (IP) and who took at least 1 dose of IP. | Posted | Count of Participants | Participants | Day 1 up to 28 days after last dose of study drug (maximum up to 388 days) |
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| Secondary | 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. | Population analysis set included all participants randomly assigned to IP and who took at least 1 dose of IP. | Posted | Count of Participants | Participants | Day 1 up to 28 days after last dose of study drug (maximum up to 388 days) |
|
From day 1 up to maximum 388 days.
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A: Commercial Capsule Fast | Current commercial talazoparib formulation 1 mg once daily was given under fasted conditions (reference for BE evaluation). | 4 | 65 | 9 | 65 | 25 | 65 |
| EG001 | Treatment B: Soft Gel Capsule Fast | The proposed talazoparib soft gelatin capsule formulation 1 mg once daily was given under fasted conditions (test for BE evaluation, reference for food-effect evaluation). | 5 | 60 | 7 | 60 | 25 | 60 |
| EG002 | Treatment C: Soft Gel Capsule Fed | The proposed talazoparib soft gelatin capsule formulation 1 mg once daily was given with food (on the PK sampling day, high-fat/high-calorie meal was administered in the clinical sites prior to the administration of the proposed talazoparib soft gelatin capsule formulation; test for food-effect evaluation). | 0 | 30 | 1 | 30 | 12 | 30 |
| EG003 | Maintenance | Participants who had repeated a period 2 times but still could not meet PK evaluable criteria, needed a dose reduction, had unstable renal function, had experienced renal function worsening to moderate/severe renal impairment during the study, or had completed the food effect assessment, was rolled over to the maintenance phase which consisted of repeating 28 day cycles of treatment with the current commercial formulation. | 1 | 41 | 7 | 41 | 20 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v25.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_inquires@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2022 | Dec 12, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C586365 | talazoparib |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Refused further treatment |
|
| Other |
|
| Refused further treatment |
|
| Other |
|
| Unknown or Not Reported |
|
| Asian |
|
| Not reported |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
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|
|
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The proposed talazoparib soft gelatin capsule formulation 1 mg once daily was given with food (on the PK sampling day, high-fat/high-calorie meal was administered in the clinical sites prior to the administration of the proposed talazoparib soft gelatin capsule formulation; test for food-effect evaluation).
|
|
|
|
The proposed talazoparib soft gelatin capsule formulation 1 mg once daily was given with food (on the PK sampling day, high-fat/high-calorie meal was administered in the clinical sites prior to the administration of the proposed talazoparib soft gelatin capsule formulation; test for food-effect evaluation).
|
|
The proposed talazoparib soft gelatin capsule formulation 1 mg once daily was given with food (on the PK sampling day, high-fat/high-calorie meal was administered in the clinical sites prior to the administration of the proposed talazoparib soft gelatin capsule formulation; test for food-effect evaluation). |
|
|
| OG002 | Treatment C: Soft Gel Capsule Fed | The proposed talazoparib soft gelatin capsule formulation 1 mg once daily was given with food (on the PK sampling day, high-fat/high-calorie meal was administered in the clinical sites prior to the administration of the proposed talazoparib soft gelatin capsule formulation; test for food-effect evaluation). |
| OG003 | Maintenance | Participants who had repeated a period 2 times but still could not meet PK evaluable criteria, needed a dose reduction, had unstable renal function, had experienced renal function worsening to moderate/severe renal impairment during the study, or had completed the food effect assessment, was rolled over to the maintenance phase which consisted of repeating 28 day cycles of treatment with the current commercial formulation. |
|
|
| OG002 | Treatment C: Soft Gel Capsule Fed | The proposed talazoparib soft gelatin capsule formulation 1 mg once daily was given with food (on the PK sampling day, high-fat/high-calorie meal was administered in the clinical sites prior to the administration of the proposed talazoparib soft gelatin capsule formulation; test for food-effect evaluation). |
| OG003 | Maintenance | Participants who had repeated a period 2 times but still could not meet PK evaluable criteria, needed a dose reduction, had unstable renal function, had experienced renal function worsening to moderate/severe renal impairment during the study, or had completed the food effect assessment, was rolled over to the maintenance phase which consisted of repeating 28 day cycles of treatment with the current commercial formulation. |
|
|