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
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deciphera Pharmaceuticals LLC
• Treatments: Repaglinide

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.