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

Launched by DECIPHERA PHARMACEUTICALS, LLC · Feb 8, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different medications, ripretinib and sunitinib, to see which one works better for patients with a type of cancer called gastrointestinal stromal tumors (GIST) that have certain genetic changes. The study is for adults who have already been treated with another medication called imatinib but their cancer has continued to grow. To participate, you need to be at least 18 years old and have a confirmed diagnosis of GIST with specific genetic mutations. You also need to have measurable tumors and be in good enough health to take part in the study.

If you join the trial, you will be randomly assigned to receive either ripretinib or sunitinib. If your cancer does not improve while taking sunitinib, you may have the option to switch to ripretinib. The study is currently recruiting participants, and it includes people of all genders. It’s important to know that there are some health conditions that might prevent you from joining, such as certain heart issues or other serious medical problems. Overall, this trial aims to find out which medication might help patients with advanced GIST more effectively.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.