IDRX-42 + Sunitinib for Gastrointestinal Stromal Tumor
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new drug, IDRX-42, is more effective than the existing drug, sunitinib, for treating Gastrointestinal Stromal Tumors (GIST). It targets individuals whose GIST has spread or cannot be surgically removed and who have not responded to the drug imatinib. Participants must have a confirmed diagnosis of GIST that is either metastatic or inoperable. As a Phase 3 trial, this study serves as the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that IDRX-42 has been tested in people with advanced gastrointestinal stromal tumors (GIST). In these studies, most participants tolerated IDRX-42 well, experiencing no serious side effects. Some experienced mild or moderate side effects, which caused discomfort but were not severe for most.
Sunitinib, the other drug in this study, has received FDA approval for treating GIST, indicating its safety is well-understood. Common side effects include fatigue, diarrhea, and changes in skin color, but these are usually manageable.
Both treatments have undergone safety studies, and while side effects can occur, they are often not severe. Participants should discuss any concerns with their doctor to understand what to expect and how to manage any possible side effects.12345Why do researchers think this study treatment might be promising for GIST?
Researchers are excited about IDRX-42 for treating gastrointestinal stromal tumor (GIST) because it offers a novel approach compared to existing therapies like imatinib and regorafenib. Unlike these standard treatments, which primarily target the KIT and PDGFRA mutations in GIST, IDRX-42 introduces a new mechanism by targeting additional pathways that could overcome resistance found in later-stage tumors. Additionally, when combined with sunitinib, a well-established therapy, there’s potential for enhanced effectiveness, providing hope for patients who have limited options after resistance to first-line treatments.
What evidence suggests that this trial's treatments could be effective for Gastrointestinal Stromal Tumor?
Research has shown that IDRX-42, also known as GSK6042981, holds promise for treating Gastrointestinal Stromal Tumors (GIST). In early studies, IDRX-42 reduced tumor size in about 29% of patients, a significant outcome for those who have tried other treatments. IDRX-42 targets specific proteins in cancer cells to halt tumor growth. In this trial, participants will receive either IDRX-42 or sunitinib, an existing treatment effective for GIST after treatments like imatinib. Studies suggest both drugs have potential, but IDRX-42 might offer new hope for patients whose cancer has spread or cannot be surgically removed.23467
Are You a Good Fit for This Trial?
This trial is for adults with Gastrointestinal Stromal Tumors (GIST) that have spread or can't be removed by surgery, and who've already tried imatinib. Participants must have confirmed GIST diagnosis and provide tumor tissue for analysis. They cannot join if they haven't progressed on or tolerated imatinib.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either IDRX-42 or Sunitinib to evaluate effectiveness and safety in treating GIST
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IDRX-42
- Sunitinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School