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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04530981
Recruitment Status : Active, not recruiting
First Posted : August 28, 2020
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC

Study Description
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Brief Summary:
Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Substrate

Condition or disease Intervention/treatment Phase
GIST - Gastrointestinal Stromal Tumor Drug: Ripretinib Drug: Repaglinide Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 22, 2021
Actual Primary Completion Date : November 16, 2023
Estimated Study Completion Date : March 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Ripretinib
Oral KIT/PDGFRA kinase inhibitor
Other Name: QINLOCK

Drug: Repaglinide
Oral antihyperglycemic agent


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530981


Locations
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United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Deciphera Pharmaceuticals LLC
More Information
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Responsible Party: Deciphera Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT04530981    
Other Study ID Numbers: DCC-2618-01-007
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Repaglinide
Hypoglycemic Agents
Physiological Effects of Drugs