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

NCT ID: NCT04530981

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-22
• Study Completion Date: 2024-07-29

Brief Summary

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

Conditions

GIST - Gastrointestinal Stromal Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Repaglinide 0.5 mg + Ripretinib 150 mg QD

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.

Group Type: EXPERIMENTAL

Ripretinib

Intervention Type: DRUG

Oral KIT/PDGFRA kinase inhibitor

Repaglinide

Intervention Type: DRUG

Oral antihyperglycemic agent

Interventions

Ripretinib

Oral KIT/PDGFRA kinase inhibitor

Intervention Type: DRUG

Repaglinide

Oral antihyperglycemic agent

Intervention Type: DRUG

Other Intervention Names

QINLOCK

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deciphera Pharmaceuticals, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayo Clinic Florida

Jacksonville, Florida, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

DCC-2618-01-007

Identifier Type: -

Identifier Source: org_study_id