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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 drug developed by GSK plc for oncology. It was studied in non-Hodgkin lymphoma and reached Phase 1 clinical development. It is not an approved medicine and remains an experimental agent that was evaluated in a single completed early-stage trial.
GSK461364 was studied as a treatment for non-Hodgkin lymphoma, a group of blood cancers affecting the lymphatic system. It was tested in a Phase 1 trial in adults with this condition. It is investigational and has not been approved for treating non-Hodgkin lymphoma or any other indication.
GSK461364 targets PLK1, or polo-like kinase 1, and acts as an inhibitor of this enzyme. PLK1 is involved in regulating cell division, and inhibiting it is the intended mechanism of action for this small molecule in oncology research. The drug was designed to interfere with that target in cancer cells.
GSK461364 is made by GSK plc, which trades under the ticker GSK. The company developed and sponsored the clinical program for this compound. GSK is the sole developer named for GSK461364 in its non-Hodgkin lymphoma study.
GSK461364 is in Phase 1 development. Its only recorded clinical trial was a Phase 1 study that has been completed, and no active trials are ongoing. The drug is investigational and has not received FDA approval for any indication.
GSK461364 was evaluated in one clinical trial, NCT00536835, titled a study to assess the pharmacokinetics and pharmacodynamics of GSK461364 in subjects with non-Hodgkin lymphoma. That Phase 1 trial enrolled 41 participants in the United Kingdom and is now completed.