Gastrointestinal NeoplasmsPhase 2NCT07843641
A Legacy Study in Participants With Gastrointestinal Stromal Tumors (GIST)
A Phase 2 study testing Velzatinib in people with Gastrointestinal Neoplasms, run by GlaxoSmithKline.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms
- What is being tested?
- Velzatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 13 Oct 2026to 31 Jan 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Velzatinib
- Keywords
- Velzatinib, GSK6042981, Gastrointestinal Stromal Tumors
- Medical subject headings
- Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelzatinibDrug
Also called GSK6042981
Velzatinib will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Velzatinib | Experimental | Not described Receives: Drug: Velzatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measured: Up to 224 weeks
Duration of TEAEs and SAEs
Measured: Up to 224 weeks
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity
Measured: Up to 224 weeks
Number of participants with adverse events or serious adverse events leading to dose modification or study intervention discontinuation
Measured: 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
Measured: Up to 224 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start13 Oct 2026 (estimated)
- Primary completion31 Jan 2031 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843641
- Sponsor's protocol ID
- 310019
- Other IDs
- 2026-526452-31
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07843641
- Acronym / sponsor ID
- 310019
- Conditions
- Gastrointestinal Neoplasms
- Keywords
- Velzatinib, GSK6042981, Gastrointestinal Stromal Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2031 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Velzatinib | Experimental | Drug: Velzatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VelzatinibAlso: GSK6042981Velzatinib will be administered. | Drug | Velzatinib |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Up to 224 weeks
Duration of TEAEs and SAEs
Time frame: Up to 224 weeks
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity
Time frame: Up to 224 weeks
Number of participants with adverse events or serious adverse events leading to dose modification or study intervention discontinuation
Time frame: 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
Time frame: Up to 224 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Related trials for Gastrointestinal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Velzatinib in people with Gastrointestinal Neoplasms, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (time frame: Up to 224 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.