Gastrointestinal Neoplasms
Conditions
Keywords
GIST, Gastrointestinal Stromal Tumor
Brief 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
Interventions
DRUGVelzatinib (GSK6042981)
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion 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
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
Outcome results
None listed