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

GIST - Gastrointestinal Stromal Tumor Clinical Trial

Official title:

A Phase 1 Open-label, Multicenter Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate (Repaglinide) in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04530981
• Other study ID #: DCC-2618-01-007
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 22, 2021
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Deciphera Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: March 2025
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors
• GIST - Gastrointestinal Stromal Tumor

Intervention

Drug:
• Ripretinib
Oral KIT/PDGFRA kinase inhibitor
• Repaglinide
Oral antihyperglycemic agent

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Deciphera Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration for Repaglinide	Measure the Cmax	Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
Primary	Area under the concentration-time curve (AUC) from time 0 up to time t (AUC0-t) for Repaglinide	Measure the AUC0-t	Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
Primary	AUC from time 0 and extrapolated to infinity (AUC0-8)	Measure the AUC0-8	Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
Secondary	Incidence of Adverse Events	Adverse events [TEAEs, SAEs], dose reduction, dose interruption, or discontinuation, vital signs (heart rate [beats/min], and changes in laboratory parameters (chemistry, hematology, urinalysis, coagulation).	Cycle 1 through study completion (~ 12 months). Each cycle is 28 days.