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

NCT01773421

Phase 1 Completed 45 enrolled Eisai Inc.
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

EvaluationDrugModalityDoseRoute
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

Indications