StrateGIST Frontline

 StrateGIST Frontline: Velzatinib (IDRX-42) vs. Imatinib in patients with metastatic or unresectable GIST, as first-line treatment. 

Agent: Velzatinib (IDRX-42)
Imatinib
Phase III
Status Recruiting
Sponsor GlaxoSmithKline

 

For further information please consult https://clinicaltrials.gov/study/NCT07585266

The purpose of this study is to find out if a new drug, Velzatinib (also known as IDRX-42 or GSK6042981), is effective in treating adults with Gastrointestinal Stromal Tumors (GIST). The study will assess if Velzatinib works well and is safe for participants with previously untreated GIST, which has spread or cannot be surgically removed. Velzatinib will be compared with Imatinib, the standard treatment in firstline, to assess whether it can delay disease worsening and is safe and well tolerated.

A Phase 3, Randomized, Multicenter, Open-Label Study of Velzatinib (GSK6042981) Versus Imatinib in Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST)

WHO is the trial for?

  • 18 years and older
  • Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
  • Patients who have not received prior systemic therapy for their metastatic and/or surgically unresectable GIST.
  • Tumor tissue should be available to be submitted to the central laboratory for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy.

Additional medical eligibility criteria apply and are reviewed by the study team

WHAT is the key question that this trial is attempting to answer?

Is IDRX-42 effective and safe as a first line treatment in adults with metastatic or unresectable GIST when compared to imatinib?

WHY patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

This study is not yet open for recruitment.

WHERE is the trial available?

The trial will be conducted in several countries. For further information check here.

US contact :

Name: US GSK Clinical Trials Call Center
Phone Number: 877-379-3718
Email: GSKClinicalSupportHD@gsk.com

EU contact:

Name: EU GSK Clinical Trials Call Center
Phone Number: +44 (0) 20 89904466
Email: GSKClinicalSupportHD@gsk.com

STUDY DESIGN: What does the study look like?

Open label design.

Patients in Group A receive Velzatinib (IDRX-42) (orally)
Patients in Group B receive Imatinib (orally)

HOW do I get more information?

Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients.

If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken