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

Overview

About this study

The purpose of this study is to evaluate the effect of Ripretinib on the pharmacokinetics of a CYP2C8 Substrate.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Steven Attia, D.O.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20509322

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