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Compares treatment options for Gastrointestinal Neoplasms
Official title A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy
ClinicalTrials.gov ID: NCT07218926
What this study is testing
What is IDRX-42?
IDRX-42 is an investigational medicine, being studied as a potential treatment for gastrointestinal neoplasms.
Also referred to as velzatinib - subject to USAN approval.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to find out if a new drug, called IDRX-42 (also known as GSK6042981), is effective in treating adults with a type of cancer called Gastrointestinal Stromal Tumors (GIST) when compared to another drug named sunitinib. The study will see if IDRX-42 works well and is safe for participants whose GIST has spread or cannot be surgically removed, and who have already taken the drug imatinib.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
- Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease.
- Documented mutation status of KIT and/or PDGFRA using a tissue based next-generation sequencing or polymerase chain reaction (PCR) assay.
- Tumor tissue must be available for retrospective biomarker analysis. Sample may be archival or new biopsy.
You likely can't join if
- GIST that is both KIT and PDGFRA wild-type or known to harbor an activating PDGFRA exon 18 mutation.
- Known untreated or active central nervous system metastases.
- Participants with a known allergy or hypersensitivity to any component of IDRX-42 (GSK6042981) or sunitinib. Participants with a history of...
- Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Iowa City, Iowa, United States
- Overland Park, Kansas, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Lake Success, New York, United States
- New York, New York, United States
- Rochester, New York, United States
- Durham, North Carolina, United States
+ 89 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; San Francisco, California, United States; New Haven, Connecticut, United States; Jacksonville, Florida, United States and 103 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 ClinicalTrials.gov; the study team decides eligibility.