Phase I Clinical Study of E7389
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|