ACTIVE_NOT_RECRUITING

A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

Conditions

GIST advanced gastrointestinal tumors gastrointestinal stromal tumors imatinib ripretinib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib.

Official Title

An International, Phase 3, Randomized, Multicenter, Open-label Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With KIT Exon 11 and Co-occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated With Imatinib

Quick Facts

Study Start:2023-12-13

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05734105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female ≥18 years of age. 2. Histologic diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample. 3. Participants must have advanced GIST and radiologic progression on imatinib treatment. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening. 5. Female participants of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug. 6. Participants of reproductive potential must agree to follow contraception requirements. 7. Participants must have at least 1 measurable lesion according to mRECIST v1.1 within 21 days prior to the first dose of study drug. 8. Adequate organ function and bone marrow reserve based on laboratory assessments performed at screening.	1. History of KIT exon 9 mutation or detection of KIT exon 9, 13, or 14 mutations in a ctDNA sample. 2. Has known active central nervous system metastases. 3. New York Heart Association Class II-IV heart disease, myocardial infarction within 6 months of Cycle 1 Day 1, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or congestive heart failure. 4. Use of strong or moderate inhibitors or inducers of cytochrome P450 (CYP) 3A prior to the first dose of study drug, and consumption of grapefruit or grapefruit juice within 14 days prior to the first dose of study drug. 5. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug. 6. Known human immunodeficiency virus or hepatitis C infection only if the participant is taking medications that are excluded per protocol, acute or chronic hepatitis B, or acute or chronic hepatitis C infection. 7. Gastrointestinal abnormalities including, but not limited to: 1. inability to take oral medication 2. malabsorption syndromes 3. requirement for intravenous alimentation 8. Any active bleeding excluding hemorrhoidal or gum bleeding.

Inclusion Criteria

Exclusion Criteria

1. Male or female ≥18 years of age.
2. Histologic diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample.
3. Participants must have advanced GIST and radiologic progression on imatinib treatment.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening.
5. Female participants of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug.
6. Participants of reproductive potential must agree to follow contraception requirements.
7. Participants must have at least 1 measurable lesion according to mRECIST v1.1 within 21 days prior to the first dose of study drug.
8. Adequate organ function and bone marrow reserve based on laboratory assessments performed at screening.

1. History of KIT exon 9 mutation or detection of KIT exon 9, 13, or 14 mutations in a ctDNA sample.
2. Has known active central nervous system metastases.
3. New York Heart Association Class II-IV heart disease, myocardial infarction within 6 months of Cycle 1 Day 1, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or congestive heart failure.
4. Use of strong or moderate inhibitors or inducers of cytochrome P450 (CYP) 3A prior to the first dose of study drug, and consumption of grapefruit or grapefruit juice within 14 days prior to the first dose of study drug.
5. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug.
6. Known human immunodeficiency virus or hepatitis C infection only if the participant is taking medications that are excluded per protocol, acute or chronic hepatitis B, or acute or chronic hepatitis C infection.
7. Gastrointestinal abnormalities including, but not limited to:
1. inability to take oral medication
2. malabsorption syndromes
3. requirement for intravenous alimentation
8. Any active bleeding excluding hemorrhoidal or gum bleeding.

Contacts and Locations

Principal Investigator

Clinical Team

STUDY_DIRECTOR

Deciphera Pharmaceuticals, LLC

Study Locations (Sites)

UC San Diego Moores Cancer Center

La Jolla, California, 92093

United States

Yale University

New Haven, Connecticut, 06520

United States

Mayo Clinic Florida

Jacksonville, Florida, 32224

United States

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Johns Hopkins Hospital

Baltimore, Maryland, 21287

United States

Boston Medical Center

Boston, Massachusetts, 02118

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, 55455

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Northwell Health Cancer Institute/ R.J. Zuckerberg Cancer Center

New York, New York, 11042

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

University of Virginia

Charlottesville, Virginia, 22908

United States

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Deciphera Pharmaceuticals, LLC

Clinical Team, STUDY_DIRECTOR, Deciphera Pharmaceuticals, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-13

Study Completion Date2028-12

Study Record Updates

Study Start Date2023-12-13

Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

advanced gastrointestinal tumors
gastrointestinal stromal tumors
imatinib
ripretinib

Additional Relevant MeSH Terms

GIST