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History of Changes for Study: 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
Latest version (submitted August 3, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 11, 2020 None (earliest Version on record)
2 December 22, 2020 Contacts/Locations and Study Status
3 January 14, 2021 Recruitment Status, Study Status, Contacts/Locations, Oversight and Study Identification
4 February 8, 2021 Contacts/Locations and Study Status
5 March 18, 2021 Contacts/Locations and Study Status
6 March 22, 2021 Contacts/Locations and Study Status
7 April 7, 2021 Contacts/Locations and Study Status
8 May 12, 2021 Contacts/Locations and Study Status
9 May 21, 2021 Contacts/Locations and Study Status
10 June 1, 2021 Contacts/Locations and Study Status
11 June 21, 2021 Study Status and Contacts/Locations
12 June 30, 2021 Contacts/Locations and Study Status
13 July 15, 2021 Study Status and Contacts/Locations
14 August 3, 2021 Study Status and Contacts/Locations
15 August 16, 2021 Contacts/Locations and Study Status
16 October 26, 2021 Conditions, Study Status, Contacts/Locations, Eligibility and Study Design
17 December 21, 2021 Study Status
18 January 5, 2022 Recruitment Status, Study Status and Contacts/Locations
19 January 13, 2022 Contacts/Locations and Study Status
20 January 20, 2022 Study Design and Study Status
21 February 14, 2022 Study Status
22 June 7, 2022 Study Status and Contacts/Locations
23 July 20, 2022 Study Status and Contacts/Locations
24 August 3, 2022 Recruitment Status, Study Status and Study Design
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Study NCT04672460
Submitted Date:  December 11, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: C3441037
Brief Title: 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
Official Title: A PHASE 1, OPEN LABEL, CROSSOVER STUDY TO ESTABLISH BIOEQUIVALENCE BETWEEN THE PROPOSED SOFT GEL TALAZOPARIB CAPSULE FORMULATION AND THE CURRENT TALAZOPARIB COMMERCIAL FORMULATION AND TO ESTIMATE THE FOOD EFFECT ON PHARMACOKINETICS OF THE PROPOSED TALAZOPARIB SOFT GEL CAPSULE FORMULATION IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2020
Overall Status: Not yet recruiting
Study Start: December 2020
Primary Completion: February 18, 2022 [Anticipated]
Study Completion: February 12, 2023 [Anticipated]
First Submitted: November 13, 2020
First Submitted that
Met QC Criteria:
December 11, 2020
First Posted: December 17, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
December 11, 2020
Last Update Posted: December 17, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Pfizer
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Advanced Solid Tumors
Keywords: PARP inhibitor
Talazoparib
Talzenna
Pharmacokinetics
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Crossover Assignment
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.
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 46 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. AUC24 of all talazoparib treatment
[ Time Frame: 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
2. Cmax of all talazoparib treatment
[ Time Frame: 24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3] ]

Maximum plasma concentration
Secondary Outcome Measures:
1. Tmax of all talazoparib treatment
[ Time Frame: 24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3] ]

Time for Cmax
2. Ctrough of all talazoparib treatment
[ Time Frame: 24 hours [On Day 27 for Period 1 and on Day 20 for Periods 2] ]

Predose plasma drug concentration
3. CL/F of all talazoparib treatment
[ Time Frame: 24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3] ]

Apparent clearance after oral dose
4. AUClast of all talazoparib treatment
[ Time Frame: 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)
5. Safety and tolerability of the proposed talazoparib soft gel capsule formulation
[ Time Frame: Approximately 4 years ]

Incidence of AEs characterized by type, severity (graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study treatment
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria

  1. 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.
  2. ECOG performance score of 0-1.
  3. Adequate organ function:
    • ANC ≥1500 cells/mm3
    • Platelets ≥100,000 cells/mm3
    • Hemoglobin ≥10.0 g/dL
    • 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

  1. For ovarian participants: Non-epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors.
  2. 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.
  3. Diagnosed with MDS or AML.
  4. Active infection requiring systemic therapy within 2 weeks of enrollment.
  5. 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).
  6. Known or suspected brain metastasis or active leptomeningeal disease undergoing or requiring treatment. Asymptomatic brain metastases currently not undergoing treatment are allowed.
  7. 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.
  8. 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) .
Open or close this module Contacts/Locations
Central Contact Person: Pfizer CT.gov Call Center
Telephone: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Officials: Pfizer CT.gov Call Center
Study Director
Pfizer
Locations: United States, California
California Cancer Associates for Research and Excellence, Inc (cCARE)
Encinitas, California, United States, 92024
California Cancer Associates for Research and Excellence, Inc. (cCARE)
Encinitas, California, United States, 92024
California Cancer Associates for Research and Excellence, Inc. (cCARE)
San Marcos, California, United States, 92069
Open or close this module IPDSharing
Plan to Share IPD: No
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.
Open or close this module References
Citations:
Links: Description: To obtain contact information for a study center near you, click here.
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services