Clinical Trials /

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

NCT04672460

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: C3441037
  • NCT ID: NCT04672460

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
TALZENNA capsuleSequence 1
Talazoparib soft gel capsuleSequence 1
Talazoparib soft gel capsuleSequence 1

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Sequence 1ExperimentalParticipants receive Treatment B for 28 days, followed by Treatment A for 21 days, followed by Treatment C for 21 days.
  • TALZENNA capsule
  • Talazoparib soft gel capsule
  • Talazoparib soft gel capsule
Sequence 2ExperimentalParticipants receive Treatment A for 28 days, followed by Treatment B for 21 days, followed by Treatment C for 21 days.
  • TALZENNA capsule
  • Talazoparib soft gel capsule
  • Talazoparib soft gel capsule

Eligibility 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) .
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:AUC24 of all talazoparib treatment
Time Frame:24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3]
Safety Issue:
Description:Area under the plasma concentration-time curve from time 0 to 24 hours

Secondary Outcome Measures

Measure:Tmax of all talazoparib treatment
Time Frame:24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3]
Safety Issue:
Description:Time for Cmax
Measure:Ctrough of all talazoparib treatment
Time Frame:24 hours [On Day 27 for Period 1 and on Day 20 for Periods 2]
Safety Issue:
Description:Predose plasma drug concentration
Measure: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]
Safety Issue:
Description:Apparent clearance after oral dose
Measure:AUClast of all talazoparib treatment
Time Frame:24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3]
Safety Issue:
Description:Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)
Measure:Safety and tolerability of the proposed talazoparib soft gel capsule formulation
Time Frame:Approximately 4 years
Safety Issue:
Description:Incidence of AEs characterized by type, severity (graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study treatment

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Pfizer

Trial Keywords

  • PARP inhibitor
  • Talazoparib
  • Talzenna
  • Pharmacokinetics

Last Updated

December 23, 2020