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

  • STATUS
    Recruiting
  • days left to enroll
    79
  • participants needed
    30
  • sponsor
    Deciphera Pharmaceuticals LLC
Updated on 15 December 2021

Summary

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

Details
Condition GIST - Gastrointestinal Stromal Tumor
Treatment repaglinide, ripretinib
Clinical Study IdentifierNCT04530981
SponsorDeciphera Pharmaceuticals LLC
Last Modified on15 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients ≥18 years of age
Patients must have a histologic diagnosis of GIST
Patients must have GIST that has progressed on or have intolerance to at least 2 lines of prior TKI therapies
Patients must have an Eastern Cooperative Oncology Group performance score of ≤ 2
If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements
Adequate organ and bone marrow function

Exclusion Criteria

Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose
Prior treatment with ripretinib
Patients who have had prior repaglinide treatment within 30 days of screening
History or presence of clinically relevant cardiovascular abnormalities
Gastrointestinal abnormalities including but not limited to
inability to take oral medication
malabsorption syndromes
requirement for intravenous alimentation
Patients who have type 1 or type 2 diabetes
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