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
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