A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib (INSIGHT)
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05734105 |
Recruitment Status :
Recruiting
First Posted : February 17, 2023
Last Update Posted : May 3, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
GIST | Drug: Ripretinib Drug: Sunitinib | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | December 13, 2023 |
Estimated Primary Completion Date : | February 2026 |
Estimated Study Completion Date : | December 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Ripretinib
150 mg QD of ripretinib (3×50 mg tablets) will be dosed continuously in repeated 42-day cycles.
|
Drug: Ripretinib
50 mg tablets
Other Name: QINLOCK, DCC-2618 |
Active Comparator: Sunitinib
50 mg QD of sunitinib (4×12.5 mg capsules) will be dosed in 42-day cycles. Sunitinib will be given continuously for 4 weeks with a 2-week break.
|
Drug: Sunitinib
12.5 mg tablets
Other Name: Sutent |
- Progression-free Survival (PFS) [ Time Frame: Up to end of treatment; up to approximately 48 months ]The time from randomization until documented progressive disease (PD) based on IRR per mRECIST or death due to any cause, whichever occurs first.
- Objective Response Rate (ORR) [ Time Frame: Up to end of treatment; up to approximately 48 months ]Compare ORR by IRR of ripretinib vs sunitinib using mRECIST
- Overall Survival (OS) [ Time Frame: Up to approximately 48 months ]Compare OS of ripretinib vs sunitinib
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female ≥18 years of age.
- Histologic diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample.
- Participants must have advanced GIST and radiologic progression on imatinib treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening.
- Female participants of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug.
- Participants of reproductive potential must agree to follow contraception requirements.
- Participants must have at least 1 measurable lesion according to mRECIST v1.1 within 21 days prior to the first dose of study drug.
- Adequate organ function and bone marrow reserve based on laboratory assessments performed at screening.
- Resolution of all toxicities from prior therapy to Grade ≤1 (or participant baseline) within 1 week prior to the first dose of study drug.
Exclusion Criteria:
- History of KIT exon 9 mutation or detection of KIT exon 9, 13, or 14 mutations in a ctDNA sample.
- Has known active central nervous system metastases.
- 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.
- 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.
- Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug.
- 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.
-
Gastrointestinal abnormalities including, but not limited to:
- inability to take oral medication
- malabsorption syndromes
- requirement for intravenous alimentation
- Any active bleeding excluding hemorrhoidal or gum bleeding.
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): NCT05734105
Contact: Clinical Team | 785-830-2100 | Clinicaltrials@deciphera.com |
Study Director: | Clinical Team | Deciphera Pharmaceuticals LLC |
Responsible Party: | Deciphera Pharmaceuticals LLC |
ClinicalTrials.gov Identifier: | NCT05734105 |
Other Study ID Numbers: |
DCC-2618-03-003 |
First Posted: | February 17, 2023 Key Record Dates |
Last Update Posted: | May 3, 2024 |
Last Verified: | May 2024 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
advanced gastrointestinal tumors gastrointestinal stromal tumors imatinib ripretinib |
Sunitinib Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances |
Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |