Last updated: 09/22/2026 15:50:58

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

GSK study ID
310019
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
2026-526452-31
Trial status
Not yet recruiting
Not yet recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 2, StrateGIST Legacy Study to Provide Continued Treatment with Velzatinib to Participants With Gastrointestinal Stromal Tumors (GIST) Who Have Completed a Velzatinib Parent Study
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: Up to 224 weeks

Duration of TEAEs and SAEs

Timeframe: Up to 224 weeks

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

Timeframe: Up to 224 weeks

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

Timeframe: 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

Timeframe: Up to 224 weeks

Secondary outcomes:
Not applicable
Interventions:
Drug: Velzatinib
Enrollment:
72
Primary completion date:
2031-31-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Gastrointestinal Neoplasms
Product
GSK6042981
Collaborators
Not applicable
Study date(s)
October 2026 to January 2031
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • 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 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.
Inclusion and exclusion criteria
Inclusion criteria:

    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.
Exclusion criteria:

    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.

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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