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GSK461364 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Stage A | EXPERIMENTAL | Stage A will identify maximum tolerated doses for either Schedule 1 - GSK461364 given once weekly on Day 1, 8 and 15 every 28 days; Schedule 2 - GSK 461364 given twice weekly Days 1, 2, 8, 9, 15 and 16; Schedule 3 Daily on Day 1 to Day 15 every 21 days. |
| Stage B | EXPERIMENTAL | Evaluate safety, PK, pharmacodynamic (PD) \& tumor response in expanded cohorts at the MTD for at least one schedule from Stage A. |
| Name | Type | Description |
|---|---|---|
| GSK461364 | DRUG | GSK461364 will be given intravenously as a 4 hour infusion in either a final volume of 500 or 1000 mLs. The starting dose for Stage A - Schedule 1 was 50 mg and doses were to be escalated as described in protocol until maximum tolerated dose established. |
Inclusion Criteria: * Confirmed diagnosis of advanced solid tumor or Non-Hodgkins Lymphoma (excluding HIV-associated lymphoma) that has relapsed or is refractory to standard therapies * At least 18 years of age * Female who are of non-childbearing potential or who have a negative pregnancy test who...
GSK461364 is an investigational small molecule being studied for the treatment of Non-Hodgkin lymphoma. It was evaluated in a Phase 1 clinical trial that has been completed. The drug is not approved and remains in clinical development.
GSK461364 is being developed by GSK plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol GSK. The company conducted a Phase 1 study of the drug in subjects with Non-Hodgkin lymphoma.
GSK461364 is in Phase 1 clinical development. A Phase 1 study of the drug in Non-Hodgkin lymphoma has been completed. The drug is investigational and has not been approved by regulatory authorities.
GSK461364 has one completed clinical trial, NCT00536835, titled 'Study to Assess the Pharmacokinetics and Pharmacodynamics of GSK461364 in Subjects With Non-Hodgkins Lymphoma.' This Phase 1 study enrolled 41 participants in the United Kingdom.
GSK461364 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial for Non-Hodgkin lymphoma. The drug remains in clinical development and has not been authorized for commercial use.