Back to results

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

Primary Purpose

GIST - Gastrointestinal Stromal Tumor

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ripretinib

Repaglinide

About this trial

This is an interventional treatment trial for GIST - Gastrointestinal Stromal Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 30 days of screening.
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.

Sites / Locations

Mayo Clinic FloridaRecruiting
Sylvester Comprehensive Cancer CenterRecruiting
Oregon Health & Science UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Repaglinide 0.5 mg + Ripretinib 150 mg QD

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration for Repaglinide

Measure the Cmax

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

Measure the AUC0-t

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

Measure the AUC0-∞

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT04530981

First Posted

August 24, 2020

Last Updated

August 4, 2023

Sponsor

Deciphera Pharmaceuticals LLC

1. Study Identification

Unique Protocol Identification Number

NCT04530981

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 22, 2021 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Deciphera Pharmaceuticals LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

GIST - Gastrointestinal Stromal Tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Repaglinide 0.5 mg + Ripretinib 150 mg QD

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ripretinib

Other Intervention Name(s)

QINLOCK

Intervention Description

Oral KIT/PDGFRA kinase inhibitor

Intervention Type

Drug

Intervention Name(s)

Repaglinide

Intervention Description

Oral antihyperglycemic agent

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration for Repaglinide

Description

Measure the Cmax

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.

Title

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

Description

Measure the AUC0-t

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.

Title

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

Description

Measure the 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.

Secondary Outcome Measure Information:

Title

Incidence of Adverse Events

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Study Director

Phone

785-830-2100

clinicaltrials@deciphera.com

Facility Information:

Facility Name

Mayo Clinic Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Steven Attia, DO, CCRP

Facility Name

Sylvester Comprehensive Cancer Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gina Z D'Amato, MD

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael C Heinrich, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs