An Open Label Phase I Dose Escalation Study Of E7080
The purpose of this study is to determine the maximum tolerated dose (MTD) of lenvatinib in patients with solid tumors or lymphomas.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Phase I Dose Escalation Study Of E7080|
- The maximum tolerated dose as defined by an incidence of dose limiting toxicity of no more than 17% (one in six). [ Time Frame: First four weeks of treatment. ] [ Designated as safety issue: Yes ]
- Tumor assessments should be performed at screening and at appropriate clinical intervals as determined by the investigator. [ Time Frame: At screening, every 2 cycles and where clinically indicated. ] [ Designated as safety issue: No ]
- The best response to treatment with lenvatinib, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), will be documented. [ Time Frame: Every 2 cycles. ] [ Designated as safety issue: No ]
- Blood samples taken to determine the pharmacokinetic profile of lenvatinib. [ Time Frame: Blood samples taken from patient on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 of all other cycles. ] [ Designated as safety issue: No ]
- Blood samples taken to identify pharmacodynamic biomarkers of lenvatinib. [ Time Frame: Blood samples taken from patient on Days 1, 15 and 22 of Cycle 1 and on Day 1 of all other cycles. ] [ Designated as safety issue: No ]
- Adverse Events (AEs) recorded to explore the safety and tolerability of lenvatinib. [ Time Frame: All AEs are recorded in case report forms on an ongoing basis throughout the study and constantly monitored and assessed. ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2005|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Lenvatinib tablets taken orally, once daily.
Other Name: E7080
This is an open-label, non-randomized, dose escalation study. Patients will be treated with lenvatinib once daily. Each four-week treatment period will be considered to be one treatment cycle. The selection of subsequent dose levels will be performed according to an accelerated design: Although initially 3 patients per dose level will be entered, the next dose level can be opened for patient accrual after only the first patient in the previous cohort completes Cycle 1 with no drug-related toxicity greater than grade 1 (except alopecia, lymphopenia and anemia).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121719
|Glasgow, United Kingdom|
|Study Director:||Jantien Wanders, M.D.||Eisai Limited|