Phase I Clinical Study of E7389
The primary objective of this study is to determine the dose limiting toxicity and maximum tolerated dose of E7389 in patients with solid tumors. The secondary objectives are to investigate the pharmacokinetics, safety, estimated recommended dose, and anti-tumor effects (in evaluable cases) of E7389 in patients with solid tumors.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Clinical Study of E7389 in Patients With Solid Tumors|
- Number of Subjects Who Experienced Dose Limiting Toxicity (DLT) [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]DLT is an adverse drug reaction defined as 1)Grade 4 neutropenia for 5 days, 2)>/=Grade 3 febrile neutropenia, 3)>/=Grade 3 neutropenia requiring iv antibiotics, 4)Grade 4 thrombocytopenia, 5)>/=Grade 3 nonhematologic toxicity, 6)Omission of study drug on Day 8 due to >/=Grade 3 neutropenia or thrombocytopenia or investigator decision.
- Maximum Tolerated Dose (MTD) [ Time Frame: 3 Weeks ] [ Designated as safety issue: Yes ]MTD was the lowest dose at which a dose limiting toxicity occurred.
- Safety, Tolerability, the Pharmacokinetics, a Recommended Dose (RD) for Phase II Clinical Study and the Anti-tumor Effect in Evaluable Subjects. [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2006|
|Study Completion Date:||February 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m2, with planned dose levels of 1.0, 1.4, 2.0 mg/m2.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326950
|Kashiwa, Chiba-prefecture, Japan, 277-0882|
|Study Director:||Tomio Nakamura||Eisai Co., Ltd.|