Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00536835 | Study to Assess the Pharmacokinetics and Pharmacodynamics of GSK461364 in Subjects With Non-Hodgkins Lymphoma | PHASE1 | COMPLETED | 41 | — | — | Aug 16, 2007 | Sep 29, 2009 | Jun 26, 2017 | 3 | United Kingdom |
| 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...