Velzatinib for advanced GIST after multiple prior TKIs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial evaluates velzatinib (GSK6042981/IDRX-42) in Japanese participants with GI tumors, specifically GIST, who progressed after imatinib, sunitinib, regorafenib, and pimitespib. The study will assess tumor response and safety to determine if velzatinib can provide clinical benefit and be tolerated in this setting. Eligible participants must have confirmed GIST with documented KIT and/or PDGFRA mutations and may contribute tissue samples for biomarker analysis. Exclusion criteria include active CNS metastases, uncontrolled cardiovascular disease, or prior severe adverse reactions to TKIs. The trial is sponsored by GlaxoSmithKline and is conducted at GSK investigational sites in Fukuoka, Hokkaido, and Tokyo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
* Documented disease progression on or intolerance to imatinib, sunitinib, regorafenib, and pimitespib.
* Documented mutation status of KIT and/or PDGFRA.
* Tumor tissue may be available for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Investigators may consult with the sponsor regarding the enrolment of participants for whom archival tissue is no longer available and who are not eligible to undergo a new biopsy.
* Is willing to use adequate contraception male and/or female participants.

Exclusion Criteria:

* Known untreated or active central nervous system metastases.
* Has significant, uncontrolled, or active cardiovascular disease.
* Participants with a known allergy or hypersensitivity to any component of velzatinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded.
* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \[e.g., breast, cervix, bladder\] that have been resected with no evidence of metastatic disease.
* Prior treatment with ripretinib or other investigational agents that are currently under clinical development for GIST.
* Is pregnant or breastfeeding.
* Any condition or illness that, in the opinion of the Investigator, might compromise participant safety or interfere with the evaluation of the safety of the study treatment.

Where it's running

• GSK Investigational Site
  Fukuoka, Japan Recruiting
• GSK Investigational Site
  Hokkaido, Japan Recruiting
• GSK Investigational Site
  Tokyo, Japan Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• IDRX-42 versus sunitinib for adults with advanced gastrointestinal stromal tumors after imatinib

  This test compares IDRX-42 (GSK6042981) with sunitinib in adults with advanced or unresectable GIST who have already been treated with imatinib to see which controls the cancer better and is safer.

  Recruiting at 156 sites Phase 3 GlaxoSmithKline · Phoenix, Arizona and 155 other locations · NCT07218926

• Velzatinib vs. Imatinib as frontline treatment for metastatic or unresectable GIST

  This trial tests velzatinib against imatinib as the first systemic therapy for adults with newly diagnosed metastatic or unresectable gastrointestinal stromal tumors to see if velzatinib can delay progression and be tolerable.

  Recruiting at 93 sites Phase 3 GlaxoSmithKline · Scottsdale, Arizona and 92 other locations · NCT07585266

• Lenvatinib for advanced GIST after imatinib, sunitinib, and regorafenib

  This trial tests whether the oral drug lenvatinib can help people with metastatic or advanced GIST whose disease has progressed on imatinib, sunitinib, and regorafenib.

  Recruiting Phase 1/2 Asan Medical Center · Seoul · NCT07096609

• Oral Liporaxel (paclitaxel) treatment for gastrointestinal stromal tumors

  This study will test whether taking oral Liporaxel (a form of paclitaxel) can help people with advanced GIST who stopped responding to imatinib, sunitinib, and regorafenib and whose tumors have low P‑glycoprotein levels.

  Recruiting Phase 2 Asan Medical Center · Seoul, Songpagu · NCT06326346

• Combination of rivoceranib and paclitaxel for advanced gastrointestinal stromal tumors

  This study is testing if a new combination of two drugs, rivoceranib and paclitaxel, can help adults with advanced gastrointestinal stromal tumors that haven't improved with standard treatments.

  Recruiting Phase 2 Asan Medical Center · Seoul, Seoul · NCT05905887

• Preoperative Muscle Health and Postoperative Outcomes in Older Adults with GI Cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.