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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

NCT04530981

Description:

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

Related Conditions:
  • Gastrointestinal Stromal Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04530981

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: DCC-2618-01-007
  • NCT ID: NCT04530981

Conditions

  • GIST - Gastrointestinal Stromal Tumor

Interventions

DrugSynonymsArms
RipretinibQINLOCKRepaglinide 0.5 mg + Ripretinib 150 mg QD
RepaglinideRepaglinide 0.5 mg + Ripretinib 150 mg QD

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Repaglinide 0.5 mg + Ripretinib 150 mg QDExperimentalA 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.
  • Ripretinib
  • Repaglinide

Eligibility Criteria

        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.

          6. Patients who have type 1 or type 2 diabetes.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Observed Plasma Concentration for Repaglinide
Time Frame: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.
Safety Issue:
Description:Measure the Cmax

Secondary Outcome Measures

Measure:Incidence of Adverse Events
Time Frame:Cycle 1 through study completion (~ 12 months). Each cycle is 28 days.
Safety Issue:
Description: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).

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Deciphera Pharmaceuticals LLC

Last Updated

August 17, 2021