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A Drug-Drug Interaction Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate in Patients With Advanced GIST

Sponsor
Deciphera Pharmaceuticals LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04530981
Collaborator
(none)
30
Enrollment
3
Locations
1
Arm
14.3
Anticipated Duration (Months)
10
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Substrate

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Open-label, Multicenter Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate (Repaglinide) in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Actual Study Start Date :
Sep 22, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Repaglinide 0.5 mg + Ripretinib 150 mg QD

A single dose of repaglinide 0.5 mg (1 × 0.5-mg tablet) will be administered orally on Cycle 1 Day 1 and Cycle 1 Day 15. Ripretinib 150 mg QD (3 × 50-mg tablets) will be administered orally from Day 2 through Day 28 for Cycle 1 and will be administered continuously from Cycle 2 until disease progression as assessed by the Investigator, unacceptable toxicity, or withdrawal of consent.

Drug: Ripretinib
Oral KIT/PDGFRA kinase inhibitor
Other Names:
  • QINLOCK

    • Drug: Repaglinide
    Oral antihyperglycemic agent

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Observed Plasma Concentration for Repaglinide [Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.]

      Measure the Cmax

    2. Area under the concentration-time curve (AUC) from time 0 up to time t (AUC0-t) for Repaglinide [Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.]

      Measure the AUC0-t

    3. AUC from time 0 and extrapolated to infinity (AUC0-∞) [Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.]

      Measure the AUC0-∞

    Secondary Outcome Measures

    1. Incidence of Adverse Events [Cycle 1 through study completion (~ 12 months). Each cycle is 28 days.]

      Adverse events [TEAEs, SAEs, AESIs], dose reduction, dose interruption, or discontinuation, vital signs (heart rate [beats/min], and changes in laboratory parameters (chemistry, hematology, urinalysis, coagulation).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients ≥18 years of age.

    2. Patients must have a histologic diagnosis of GIST.

    3. Patients must have GIST that has progressed on or have intolerance to at least 2 lines of prior TKI therapies.

    4. Patients must have an Eastern Cooperative Oncology Group performance score of ≤ 2.

    5. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements.

    6. Adequate organ and bone marrow function.

    Exclusion Criteria:

    1. Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose.

    2. Prior treatment with ripretinib.

    3. Patients who have had prior repaglinide treatment within 30 days of screening.

    4. History or presence of clinically relevant cardiovascular abnormalities.

    5. Gastrointestinal abnormalities including but not limited to:

    • inability to take oral medication,

    • malabsorption syndromes,

    • requirement for intravenous alimentation.

    1. Patients who have type 1 or type 2 diabetes.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Florida Jacksonville Florida United States 32224
    2 Sylvester Comprehensive Cancer Center Miami Florida United States 33136
    3 Oregon Health & Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • Deciphera Pharmaceuticals LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Deciphera Pharmaceuticals LLC
    ClinicalTrials.gov Identifier:
    NCT04530981
    Other Study ID Numbers:
    • DCC-2618-01-007
    First Posted:
    Aug 28, 2020
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gastrointestinal Stromal Tumors
    Repaglinide

    Study Results

    No Results Posted as of Mar 9, 2022