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
NCT00121680 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 115
Last updated 2015-12-11
Summary
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.
Conditions
Interventions
- DRUG
-
E7080
Oral.
Sponsors & Collaborators
-
Eisai Inc.
lead INDUSTRY
Principal Investigators
-
Eisai Inc. · Eisai Limited
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-07-31
- Primary Completion
- 2011-09-30
- Completion
- 2015-05-31
Countries
- United States
Study Locations
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