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

NCT04530981 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: DCC-2618-01-007
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

GIST - Gastrointestinal Stromal Tumor

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• AUC from time 0 and extrapolated to infinity (AUC0-∞)

  Measure the AUC0-∞

  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 Outcomes (1)

• Incidence of Adverse Events

  Cycle 1 through study completion (~ 12 months). Each cycle is 28 days.

Study Arms (1)

Repaglinide 0.5 mg + Ripretinib 150 mg QD

EXPERIMENTAL

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.

Drug: Ripretinib; Drug: Repaglinide

Interventions

Ripretinib DRUG

Oral KIT/PDGFRA kinase inhibitor

Also known as: QINLOCK

Repaglinide 0.5 mg + Ripretinib 150 mg QD

Repaglinide DRUG

Oral antihyperglycemic agent

Repaglinide 0.5 mg + Ripretinib 150 mg QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 14 days prior to Cycle 1 Day 1.
• 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.

Sponsors & Collaborators

• Deciphera Pharmaceuticals, LLC: lead

Study Sites (3)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

ripretinib; repaglinide

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 28, 2020
• Study Start: September 22, 2021
• Primary Completion: November 16, 2023
• Study Completion: July 29, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)