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
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|ClinicalTrials.gov Identifier: NCT00121680|
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : December 11, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Drug: E7080||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||May 2015|
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121680
|United States, Texas|
|Dallas, Texas, United States|
|Houston, Texas, United States|
|Study Director:||Eisai Inc.||Eisai Limited|