Phase I Clinical Study of E7389
|ClinicalTrials.gov Identifier: NCT00326950|
Recruitment Status : Completed
First Posted : May 17, 2006
Results First Posted : December 20, 2011
Last Update Posted : March 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: E7389||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Clinical Study of E7389 in Patients With Solid Tumors|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||February 2008|
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.
- Number of Subjects Who Experienced Dose Limiting Toxicity (DLT) [ Time Frame: 3 weeks ]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 ]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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326950
|Kashiwa, Chiba-prefecture, Japan, 277-0882|
|Study Director:||Tomio Nakamura||Eisai Co., Ltd.|