A Phase I/Ib, Multicenter, Open-Label, Dose Escalation Study of E7080 in Patients With Solid Tumors and in Combination With Temozolomide in Patients With Advanced and/or Metastatic Melanoma
The purpose of this study is to study the safety of E7080 administered to patients with solid tumors or lymphomas.
Please note: this study is now recruiting patients with advanced and/or metastatic melanoma only.
In the current phase of this study, To determine the MTD and the pharmacokinetic profile of E7080 when given as continuous daily (qd) dosing in combination with temozolomide.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/Ib, Multicenter, Open-Label, Dose Escalation Study of E7080 in Patients With Solid Tumors and in Combination With Temozolomide in Patients With Advanced and/or Metastatic Melanoma|
- To determine the maximum tolerated dose (MTD) of E7080 for two different schedules incorporating dose interruptions. [ Time Frame: Every two cycles. ]
- Identify the dose limiting toxicities (DLT); explore safety and tolerability; determine pharmacokinetic profile; explore anti-tumor efficacy. [ Time Frame: Every two cycles. ]
|Study Start Date:||July 2005|
|Study Completion Date:||May 2015|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121680
|United States, Texas|
|Dallas, Texas, United States|
|Houston, Texas, United States|
|Study Director:||Eisai Inc.||Eisai Limited|