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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	E7820	FOOD EFFECT STUDY: Each subject (a minimum of 12 subjects) will be assigned according to a randomization code to receive a single 50 mg dose of E7820 on Day 1, either after fasting for 10 hours, or immediately after consuming a high fat breakfast. Following a 7-day washout period, the subjects will crossover and a second 50 mg dose of E7820 will be administered on Day 8.
DRUG	E7820	MTD DETERMINATION FOR BID DOSING SCHEDULE The initial dose of E7820 will be 50 mg BID. If allowed by the rules for dose escalation, the dose escalations will be to 60 mg BID, 80 mg BID, and 100 mg BID.

Timeline

• Start date: 2011-06-30
• Primary completion: 2014-04-30
• Completion: 2017-11-12
• First posted: 2013-01-23
• Last updated: 2023-06-22
• Results posted: 2020-01-18

Locations

6 sites across 2 countries: Netherlands, United Kingdom