Last updated: 09/11/2026 14:10:55
Individual Patient Expanded Access for Velzatinib (GSK6042981) in patients with Gastrointestinal Stromal Tumours with KIT mutations
GSK study ID
300826
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Available
Available
Trial overview
Official title:
Trial description: 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Velzatinib (GSK6042981)
Enrollment:
50
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Gastrointestinal Neoplasms
Product
GSK6042981
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Expanded Access
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
- Specific eligibility criteria must be met for access outside of a clinical trial. These include:
- 1. There is no satisfactory alternative treatment for the patient including approved standard of care treatments for their diagnosis of Gastrointestinal Stromal Tumour (GIST)
Inclusion and exclusion criteria
- Specific eligibility criteria must be met for access outside of a clinical trial. These include: 1. There is no satisfactory alternative treatment for the patient including approved standard of care treatments for their diagnosis of Gastrointestinal Stromal Tumour (GIST) 2. There is reason to believe that the benefit of the patient using GSK6042981 (IDRX-42) outweighs the risk 3. Patient does not qualify for other ongoing clinical trials Additional inclusion and exclusion criteria are detailed below. Inclusion Criteria: Patients are eligible to be included in the Programme only if all the following criteria apply: 1. Patient is diagnosed with Gastrointestinal Stromal Tumour (GIST) and positive for a KIT mutation (in one of exons 9, 11, 13, 17) 2. Patient has had at least 3 prior lines of therapy 3. Patient has adequate organ system function 4. Written informed consent can be obtained from the patient or legally authorized representative 5. Patient is 18 years or older 6. Required Contraception 7. 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: Patients are excluded from the Programme if any of the following criteria apply: 1. Active uncontrolled infection 2. Known hypersensitivity to GSK6042981 or any of the formulation excipients 3. Women who are pregnant or currently breastfeeding 4. ALT >2.5xULN or (for patients with documented liver metastases/tumour infiltration) has an ALT value >5xULN 5. 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. 6. 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). 7. 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 8. 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: a. RNA test negative b. 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 location(s)
No location data available.
Study documents
Not applicable
Results overview
Not applicable
Recruitment status
Available
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable
Additional information about the trial
Participate in clinical trial
Additional information
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.
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