drugset / Trial / NCT00559182
A Study of MK-8033 in Patients With Advanced Solid Tumors (MK-8033-001)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II Dose (RP2D), pharmacodynamic, and clinical activity of MK-8033. Parts A and B of the study will determine the maximum tolerated dose (MTD) and RP2D. Part C of the study will be a single panel crossover study to determine the effect of omeprazole, a gastric pH modifier, on the pharmacokinetics of MK-8033.
Timeline
- Start
- 2007-12-05
- Primary completion
- 2010-06-10
- Completion
- 2010-07-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MK-8033 | Small molecule | 25 mg | Oral |
| Subject | MK-8033 | Small molecule | 50 mg | Oral |
| Subject | MK-8033 | Small molecule | 100 mg | Oral |
| Subject | MK-8033 | Small molecule | 200 mg | Oral |
| Subject | MK-8033 | Small molecule | 400 mg | Oral |
| Subject | MK-8033 | Small molecule | 750 mg | Oral |
| Subject | MK-8033 | Small molecule | 770 mg | Oral |
| Subject | MK-8033 | Small molecule | 1500 mg | Oral |
| Subject | Omeprazole | Other / unclassified | 20 mg | — |