Trials / Completed
CompletedNCT00536835
Study to Assess the Pharmacokinetics and Pharmacodynamics of GSK461364 in Subjects With Non-Hodgkins Lymphoma
A Phase I Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of [GSK461364], a Polo-like Kinase 1 (PLK1) Inhibitor, in Adult Subjects With Advanced Solid Tumor or Non-Hodgkins Lymphoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a first time in human study that is being done to determine the maximum tolerated dose and initial pharmacokinetic parameters of GSK461364, given by IV, in adult subjects with solid tumors and Non-Hodgkins lymphoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK461364 | 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. |
Timeline
- Start date
- 2007-08-16
- Primary completion
- 2009-09-29
- Completion
- 2009-09-29
- First posted
- 2007-09-28
- Last updated
- 2017-06-26
Locations
3 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00536835. Inclusion in this directory is not an endorsement.