Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK6042981
Velzatinib · 6 trials · 3 indications
PFS is defined as time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.
ORR is defined as the percent of participants reaching confirmed complete response (CR) or partial response (PR).
| Arm | Type | Description |
|---|---|---|
| Velzatinib | EXPERIMENTAL | - |
| Imatinib | EXPERIMENTAL | - |
| Participants with mild hepatic impairment receiving Velzatinib | EXPERIMENTAL | - |
| Participants with moderate hepatic impairment receiving Velzatinib | EXPERIMENTAL | - |
| Participants with severe hepatic impairment receiving Velzatinib | EXPERIMENTAL | - |
| Participants with normal hepatic function receiving Velzatinib | ACTIVE_COMPARATOR | - |
| Participants with Moderate Renal Impairment receiving velzatinib | EXPERIMENTAL | - |
| Participants with Severe Renal Impairment receiving velzatinib | EXPERIMENTAL | - |
| Participants with Normal Renal Function receiving velzatinib | ACTIVE_COMPARATOR | - |
| Participants receiving velzatinib | EXPERIMENTAL | - |
| Participants receiving omeprazole + velzatinib | EXPERIMENTAL | - |
| Participants receiving velzatinib + cyclosporine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Velzatinib | DRUG | Velzatinib will be administered |
| Imatinib | DRUG | Imatinib will be administered |
| Cyclosporine | DRUG | Cyclosporine will be administered. |
| Omeprazole | DRUG | Omeprazole will be administered. |
Inclusion Criteria: * Is at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF). * Has histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable. * Has ...
Velzatinib is an investigational small molecule kinase inhibitor being developed by GSK plc for gastrointestinal neoplasms, including gastrointestinal stromal neoplasms. It is in Phase 2 clinical development and has not been approved by the FDA. Velzatinib is being studied in five active clinical trials with a total planned enrollment of about 800 participants.
Velzatinib is being studied for the treatment of gastrointestinal neoplasms and gastrointestinal stromal neoplasms. It is an investigational therapy in Phase 2 development and is not approved for any indication. One Phase 2 trial, NCT07843641, is evaluating Velzatinib in participants with gastrointestinal stromal tumors.
Velzatinib is a small molecule kinase inhibitor, belonging to the -tinib class of drugs. Kinase inhibitors work by blocking specific enzymes involved in cell signaling. Velzatinib is being developed for gastrointestinal neoplasms, including gastrointestinal stromal neoplasms, and is currently in Phase 2 clinical testing.
Velzatinib is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical trials evaluating Velzatinib in gastrointestinal neoplasms and gastrointestinal stromal neoplasms. The drug is currently in Phase 2 development.
Velzatinib is in Phase 2 clinical development. It is an investigational small molecule kinase inhibitor and has not been approved by the FDA for any indication. GSK plc is running five active trials, including Phase 1 studies in healthy participants and a Phase 2 study in gastrointestinal stromal tumors.
Velzatinib is being studied in five active clinical trials. These include NCT07867171, which examines the effects of renal impairment; NCT07862114, which evaluates interactions with omeprazole and cyclosporine; NCT07859735, which assesses hepatic impairment; and NCT07843641, a Phase 2 study in gastrointestinal stromal tumors. Total planned enrollment is about 800 participants.