NCT00794781

A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of E6201 in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD), safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of E6201 in subjects with advanced solid tumors.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	E6201	E6201 Part A (Dose Escalation): Intravenous (IV) infusion administered over 30 minutes once weekly for 3 weeks (Days 1, 8, and 15). The first 3 to 6 subjects of the first cohort will receive 20 mg/m\^2/week for a cycle of 3 weeks followed by a 1-week rest period. Subsequent dose escalations may increase at increments of 100% until two Grade 2 toxicities or 1 dose-limiting toxicity (DLT) are observed in a dose group. Thereafter, doses will be increased in increments of 50% or less until the maximum tolerated dose (MTD) is determined. Part B (MTD Expansion): After the MTD is determined in Part A, 15 additional subjects will continue to receive cycles at the MTD.

Timeline

• Start date: 2008-06-22
• Primary completion: 2011-08-01
• Completion: 2015-10-15
• First posted: 2008-11-20
• Last updated: 2022-10-14

Locations

12 sites across 1 country: United States