A Dose Escalation Study of E7107 Administered Intravenously on Days 1 and 8 Every 21 Days to Patients With Solid Tumors
- Registration Number
- NCT00499499
- Lead Sponsor
- Eisai Inc.
- Brief Summary
The purpose of this study is to investigate E7107 in patients with solid tumors. This is an open label, dose-escalation study of E7107. The maximum tolerated dose (MTD) of the single agent will be established by determining the occurrence of dose limiting toxicities during the first three weeks of therapy (Cycle 1). Patients in this study will be treated at multiple dose levels, starting at 0.6 mg/m\^2. Patients will receive E7107 as a 30-minute intravenous infusion on Days 1 and 8 every 21 Days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 E7107 -
- Primary Outcome Measures
Name Time Method Tumor assessments should be performed at screening and then every 2 cycles. A best response according to RECIST (Response Evaluation Criteria in Solid Tumors) will be documented by the investigator for each patient. Every 6 weeks
- Secondary Outcome Measures
Name Time Method Clinical examination (either full or symptom-directed), adverse event reporting, laboratory screens, and electrocardiograms (ECGs) will be performed at every visit. Every 21 days
Trial Locations
- Locations (2)
M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Karmanos Cancer Center
🇺🇸Detroit, Michigan, United States