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Completed

NCT Number: NCT04530981

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

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

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Key information

Conditions

GIST - Gastrointestinal Stromal Tumor Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic Florida, Jacksonville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Ripretinib

Drug

Oral KIT/PDGFRA kinase inhibitor

Other names: QINLOCK

repaglinide

Drug

Oral antihyperglycemic agent

Primary outcomes

  1. Maximum Observed Plasma Concentration for Repaglinide

    Time frame: 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.

    Measure the Cmax

  2. Area under the concentration-time curve (AUC) from time 0 up to time t (AUC0-t) for Repaglinide

    Time frame: 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.

    Measure the AUC0-t

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

    Time frame: 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.

    Measure the AUC0-∞

Secondary outcomes

  1. Incidence of Adverse Events

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

    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).

Sponsors and collaborators

Lead sponsor

Deciphera Pharmaceuticals, LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 28, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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