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

Deciphera Pharmaceuticals, LLC

Status and phase: Completed; Phase 1

Conditions: GIST - Gastrointestinal Stromal Tumor

Treatments: Drug: Repaglinide; Drug: Ripretinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04530981

DCC-2618-01-007

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 14 days prior to Cycle 1 Day 1.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Repaglinide 0.5 mg + Ripretinib 150 mg QD

Experimental group

Description:

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.

Treatment:

Drug: Repaglinide

Drug: Ripretinib