BridgeMD
A Study of Ripretinib vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) with Specific KIT Exon Mutations Who Were Previously Treated with Imatinib
EU CTIS ID: 2022-503058-37-00
What this study is testing
To compare the efficacy of ripretinib vs sunitinib as measured by progression-free survival (PFS) based on independent radiologic review (IRR) in this patient population (KIT exon 11+17/18 mutations)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female ≥18 years of age.
- Histologic diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample analyzed by the central laboratory at pre-screening
- Participants must have advanced GIST and radiologic progression on imatinib treatment. Imatinib treatment must have been discontinued at least 5 days prior to the first dose of study drug. All prior imatinib treatment will count as 1 line of therapy (eg, adjuvant imatinib and dose escalation of imatinib).
- ECOG PS of ≤2 at screening.
- Female participants of childbearing potential must have a negative serum beta-human chorionic gonadotrophin pregnancy test at screening and a negative pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug.
You likely can't join if
- Presence of co-occurring KIT exons 11+17 and/or 18 mutations that cannot be confirmed by central laboratory testing of ctDNA at pre-screening.
- History of KIT exon 9 mutation or detection of KIT exons 9, 13, or 14 mutation in a ctDNA sample by the central laboratory at pre-screening.
- Treatment with any other line of therapy in addition to imatinib for advanced GIST. Imatinib containing combination therapy in the first-line setting is not allowed.
- A prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical study are not eligible. For example, participants receiving adjuvant cancer treatment are not eligible if those medications are potentially active against GIST or excluded per protocol. NOTE: Participants with a history of breast cancer, requiring continued hormonal treatment (eg, anti-estrogen or an aromatase inhibitor) may continue treatment. Participants with a history of prostate cancer, requiring continued support with luteinizing hormone-releasing hormone agonists, with or without androgens, may continue treatment.
- Has known active central nervous system metastases.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Australia
- Taiwan
- Canada
- United States
- Chile
- United Kingdom
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Australia; Taiwan; Canada; United States; Chile and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.