drugset / Trial / NCT01773421
An Open-label, Dose Escalation, Pharmacodynamic, Pharmacokinetic, and Effect of Food Phase 1 Study of E7820 to Determine the Maximum Tolerated Dose Following Twice Daily Oral Administration in Subjects With Unresectable Solid Tumors
RandomizedCrossoverOpen-labelTreatment
Summary
This study consists of two Parts. Part A (Food Effect Study) and Part B (Determination of Maximum Tolerated Dose \[MTD\] for twice daily \[BID\] Dosing).Part A will be initiated first, and Part B will be initiated after the PK results of Part A have been evaluated.
Timeline
- Start
- 2011-06-30
- Primary completion
- 2014-04-30
- Completion
- 2017-11-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | E7820 | Small molecule | 50 mg | Oral |
| Subject | E7820 | Small molecule | 60 mg | Oral |
| Subject | E7820 | Small molecule | 80 mg | Oral |
| Subject | E7820 | Small molecule | 100 mg | Oral |