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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

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ClinicalTrials.gov Identifier: NCT04672460
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: TALZENNA capsule Drug: Talazoparib soft gel capsule Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 21, 2020
Estimated Primary Completion Date : February 18, 2022
Estimated Study Completion Date : February 12, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Talazoparib

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 :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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) .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04672460


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04672460    
Other Study ID Numbers: C3441037
2020-006101-35 ( EudraCT Number )
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Pfizer:
PARP inhibitor
Talazoparib
Talzenna
Pharmacokinetics
Additional relevant MeSH terms:
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Neoplasms
Talazoparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents