A Legacy Study in Participants With Gastrointestinal Stromal Tumors (GIST)

NCT07843641 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: 3100192026-526452-31
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the long-term safety and tolerability of velzatinib (GSK6042981) in adults with GIST who have previously received velzatinib in parent study and continue to benefit from the treatment. Participants will be monitored for side effects and overall health to better understand the effects of long-term treatment and support future care for adults with GIST.

Conditions

Gastrointestinal Neoplasms

Keywords

Velzatinib; GSK6042981; Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (5)

• Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

  Up to 224 weeks

• Duration of TEAEs and SAEs

  Up to 224 weeks

• Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity

  Up to 224 weeks

• Number of participants with adverse events or serious adverse events leading to dose modification or study intervention discontinuation

  Up to 224 weeks

• Number of participants with clinically significant changes in vital signs, laboratory parameters, cardiac function, and Eastern Cooperative Oncology Group (ECOG) performance status changes

  Up to 224 weeks

Study Arms (1)

Velzatinib

EXPERIMENTAL

Drug: Velzatinib

Interventions

Velzatinib DRUG

Velzatinib will be administered.

Also known as: GSK6042981

Velzatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is currently receiving treatment with velzatinib for gastrointestinal stromal tumors in a velzatinib parent study that has fulfilled the requirement for the primary objective.
• Participant is benefiting from treatment with velzatinib as assessed by the investigator.
• Participant can understand the study procedures and will agree to participate in the study by providing written informed consent.
• Participant is willing and able to comply with scheduled visit assessments, treatment plans, and any other study procedures.
• Participant has not developed any condition which would preclude further treatment as per parent study.
• For female participants of childbearing potential, have a negative serum or urine (as required by local regulations) beta - Human chorionic gonadotropin (hCG) pregnancy test within 7 days prior to the first dose of study drug.
• 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.

You may not qualify if:

• Participant has permanently discontinued velzatinib treatment in a velzatinib parent study for any reason.
• Participant has received any other systemic anticancer therapy between last dose on the parent study and entering this study.
• Any laboratory abnormality or clinically significant adverse event that, in the opinion of the investigator, represents a clinically significant risk to the participant if enrolled.
• Participant is pregnant or breastfeeding.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Gastrointestinal Stromal Tumors

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: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start (Estimated): October 13, 2026
• Primary Completion (Estimated): January 31, 2031
• Study Completion (Estimated): January 31, 2031
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share