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 Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
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
|
Outcome Measures
Primary Outcome Measures
- AUC24 of all talazoparib treatment [24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3]]
Area under the plasma concentration-time curve from time 0 to 24 hours
- Cmax of all talazoparib treatment [24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3]]
Maximum plasma concentration
Secondary Outcome Measures
- Tmax of all talazoparib treatment [24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3]]
Time for Cmax
- Ctrough of all talazoparib treatment [24 hours [On Day 27 for Period 1 and on Day 20 for Periods 2]]
Predose plasma drug concentration
- CL/F of all talazoparib treatment [24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3]]
Apparent clearance after oral dose
- AUClast of all talazoparib treatment [24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3]]
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)
- Safety and tolerability of the proposed talazoparib soft gel capsule formulation [Approximately 4 years]
Incidence of AEs characterized by type, severity (graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study treatment
Eligibility Criteria
Criteria
Inclusion Criteria
- Histological diagnosis of recurrent, locally advanced or metastatic solid tumor that is not amenable for treatment with curative intent.
-
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.
-
ECOG performance score of 0-1.
-
Adequate bone marrow function:
-
ANC ≥1500 cells/mm3
-
Platelets ≥100,000 cells/mm3
-
Hemoglobin ≥10.0 g/dL
- 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);
Exclusion Criteria
-
For ovarian participants: Non-epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors.
-
Toxicities from previous anti-cancer therapies must be resolved to NCI CTCAE <Grade 2, except for alopecia, sensory neuropathies ≤Grade 2, or other Grade ≤2 AEs not constituting a safety risk, based on investigator's judgment, are acceptable.
-
Diagnosed with MDS or AML.
-
Active infection requiring systemic therapy within 2 weeks of enrollment.
-
Any condition in which active bleeding or pathological conditions may carry a high risk of bleeding (eg, known bleeding disorder, coagulopathy or tumor involvement with major vessels).
-
Known or suspected brain metastasis or active leptomeningeal disease undergoing or requiring treatment. Asymptomatic brain metastases currently not undergoing treatment are allowed.
-
Known history of testing positive for HIV, AIDS, positive HBV surface antigen, positive HCV RNA, or positive COVID-19 viral test. Asymptomatic patients with no active infection detected but positive antibody tests, indicating past infection, are allowed.
-
Current or anticipated use of P-gp inhibitors, BCRP inhibitors, and P-gp inducers within 2 weeks or 5 half-lives prior to randomization (whichever is longer) .
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | California Cancer Associates for Research and Excellence, Inc (cCARE) | Encinitas | California | United States | 92024 |
2 | Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California | United States | 90048 |
3 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
4 | California Cancer Associates for Research and Excellence, Inc (cCARE) | San Marcos | California | United States | 92069 |
5 | Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | United States | 06510 |
6 | Yale-New Haven Hospital | New Haven | Connecticut | United States | 06510 |
7 | Smilow Cancer Hospital Phase 1 Unit | New Haven | Connecticut | United States | 06511 |
8 | Florida Cancer Specialists | Lake Mary | Florida | United States | 32746 |
9 | Alliance for Multispecialty Research, LLC | Kansas City | Missouri | United States | 64114 |
10 | Montefiore Medical Center | Bronx | New York | United States | 10461 |
11 | NYU Langone Hospital - Long Island Oncology | Mineola | New York | United States | 11501 |
12 | NYU Langone Hospital - Long Island | Mineola | New York | United States | 11501 |
13 | Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | United States | 10016 |
14 | NYU Investigational Pharmacy | New York | New York | United States | 10016 |
15 | NYU Langone Medical Center (Tisch Hospital) | New York | New York | United States | 10016 |
16 | University of Cincinnati Medical Center | Cincinnati | Ohio | United States | 45219 |
17 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
18 | UPCI Investigational Drug Service | Pittsburgh | Pennsylvania | United States | 15232 |
19 | UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | United States | 15232 |
20 | Upmc Shadyside | Pittsburgh | Pennsylvania | United States | 15232 |
21 | Mary Crowley Cancer Research - Medical City Hospital | Dallas | Texas | United States | 75230 |
22 | NEXT Oncology | San Antonio | Texas | United States | 78229 |
23 | Liverpool Cancer Therapy Centre | Liverpool | New South Wales | Australia | 2170 |
24 | Liverpool Hospital | Liverpool | New South Wales | Australia | 2170 |
25 | Monash Health | Clayton | Victoria | Australia | 3168 |
26 | Epworth Healthcare (Epworth Freemasons Hospital) | East Melbourne | Victoria | Australia | 3002 |
27 | Epworth Healthcare | East Melbourne | Victoria | Australia | 3002 |
28 | Epworth Healthcare | Richmond | Victoria | Australia | 3121 |
29 | Epworth Richmond Hospital (Epworth Healthcare) | Richmond | Victoria | Australia | 3121 |
30 | Epworth Healthcare | East Melbourne | Australia | 3002 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C3441037
- 2020-006101-35