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

Last updated date
Study Location
Epic Pharmacy,Newcastle Private Hospital
New Lambton Heights, New South Wales, 2305, Australia
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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 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) .

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Sequence 1
    Participants receive Treatment B for 28 days, followed by Treatment A for 21 days, followed by Treatment C for 21 days.
    Interventions:
    • Drug: TALZENNA capsule
    • Drug: Talazoparib soft gel capsule
    • Drug: Talazoparib soft gel capsule
  • Experimental: Sequence 2
    Participants receive Treatment A for 28 days, followed by Treatment B for 21 days, followed by Treatment C for 21 days.
    Interventions:
    • Drug: TALZENNA capsule
    • Drug: Talazoparib soft gel capsule
    • Drug: Talazoparib soft gel capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2020)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 12, 2023
Estimated Primary Completion Date February 18, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) .
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04672460
Other Study ID Numbers  ICMJE C3441037
2020-006101-35 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP