Gastrointestinal NeoplasmsNCT07825701
Individual Patient Expanded Access for Velzatinib (GSK6042981) in Patients With Gastrointestinal Stromal Tumours With KIT Mutations
A study testing Velzatinib (GSK6042981) in people with Gastrointestinal Neoplasms, run by GlaxoSmithKline.
Trial 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 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 (GSK6042981)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- Cirrhosis or current unstable liver or biliary disease per physician assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) is acceptable if patient otherwise meets entry criteria).
- Patients with Hepatitis B will be excluded unless the following conditions are met: for patients who are hepatitis B core antibody positive and hepatitis B surface antigen negative (HbcAb+, HBsAg-), HBV DNA must be undetectable at screening and the patient must be monitored according to standard of care during programme treatment, with antiviral therapy instituted if HBV DNA becomes detectable. For patients who are hepatitis B surface antigen positive (HBsAg+) at screening or within 3 months prior to the first dose of programme treatment, HBV DNA must be undetectable at screening, highly effective antiviral treatment must be initiated at least 4 weeks prior to the first dose of programme treatment and maintained throughout programme treatment, and the patient must be monitored and managed according to standard of care.
- Note: Presence of isolated Hep B surface antibody (HBsAb) indicating previous vaccination will not exclude a patient
- Positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of programme treatment unless the patient can meet the following criteria:
- RNA test negative
- Successful antiviral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Velzatinib (GSK6042981)
- Keywords
- GIST, Gastrointestinal Stromal Tumor
- 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.
Velzatinib (GSK6042981)Drug
Also called IDRX-42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
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
- Expanded access
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825701
- Sponsor's protocol ID
- 300826
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Patient Expanded Access for Velzatinib (GSK6042981) in Patients With Gastrointestinal Stromal Tumours With KIT Mutations
- ClinicalTrials.gov ID
- NCT07825701
- Acronym / sponsor ID
- 300826
- Conditions
- Gastrointestinal Neoplasms
- Keywords
- GIST, Gastrointestinal Stromal Tumor
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- First posted
- 17 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.
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
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| Velzatinib (GSK6042981)Also: IDRX-42 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- 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.Link provided by the sponsor.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Velzatinib (GSK6042981) 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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 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.
Are results available for this study?
Results are not available in the source record.
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.
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 17 Sep 2026.