Individual Patient Expanded Access for Velzatinib (GSK6042981) in Patients With Gastrointestinal Stromal Tumours With KIT Mutations

NCT07825701 | Unknown

• 1 other identifier: 300826
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Compassionate Use, Individual Patient access to velzatinib (GSK6042981) for eligible patients with Gastrointestinal Stromal Tumours (GIST) who have KIT mutations and at least three prior lines of therapy

Conditions

Gastrointestinal Neoplasms

Keywords

GIST, Gastrointestinal Stromal Tumor

Interventions

Velzatinib (GSK6042981) DRUG

Also known as: IDRX-42

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients are eligible to be included in the Programme only if all the following criteria apply:
• Patient is diagnosed with Gastrointestinal Stromal Tumour (GIST) and positive for a KIT mutation (in one of exons 9, 11, 13, 17)
• Patient has had at least 3 prior lines of therapy
• Patient has adequate organ system function
• Written informed consent can be obtained from the patient or legally authorized representative
• Patient is 18 years or older
• Required Contraception
• Female participants of childbearing potential, if not postmenopausal or surgically sterile, must agree to abstain from heterosexual intercourse or use a highly effective form of contraception with their sexual partners during the dosing period and for a period of at least 30 days after the end of treatment.
• Male participants with partners of childbearing potential must agree that they will abstain from heterosexual intercourse or use condoms and their partners will use highly effective contraceptive methods during the dosing period until at least 30 days after the last dose of study drug
• Patients are excluded from the Programme if any of the following criteria apply:
• Active uncontrolled infection
• Known hypersensitivity to GSK6042981 or any of the formulation excipients
• Women who are pregnant or currently breastfeeding
• ALT \>2.5xULN or (for patients with documented liver metastases/tumour infiltration) has an ALT value \>5xULN
• Total bilirubin \>1.5xULN; patients with Gilbert's syndrome can be included with total bilirubin \>1.5xULN as long as direct bilirubin is ≤1.5xULN.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Links

• If you are a Healthcare Professional who would like to request compassionate use of a GSK investigational medicine for a patient, please use the GSK Compassionate Use Request Portal.

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Gastrointestinal Stromal Tumors

Interventions

IDRX-42

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09