Phase II Study Of E7389, Halichondrin B Analogue, In Patients With Advanced Non-Small Cell Lung Cancer, NSCLC, Who Progressed During Or After Platinum-Based Doublet Chemotherapy
|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: NCT00100932|
Recruitment Status : Completed
First Posted : January 10, 2005
Results First Posted : January 31, 2012
Last Update Posted : March 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Non-Small-Cell Lung Carcinoma||Drug: E7389 28 Day Cycle Drug: E7389 21 Day Cycle||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of E7389, a Halichondrin B Analog, in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC), Who Progressed During or After Platinum-Based Doublet Chemotherapy Stratified for Prior Taxane Therapy|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||June 2008|
E7389 28 day cycle
Drug: E7389 28 Day Cycle
E7389 1.4 mg/m^2 IV bolus on Days 1, 8, and 15 of a 28 day cycle.
E7389 21 day cycle
Drug: E7389 21 Day Cycle
E7389 1.4 mg/m^2 IV bolus on Days 1 and 8 of a 21 day cycle.
- Overall Objective Response Rate (ORR) [ Time Frame: From start of treatment until disease progression or recurrence ]Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).
- Duration of Response [ Time Frame: From time of CR or PR until recurrence or progressive disease ]Measured from the time that measurement criteria were met for complete response (CR) and partial response (PR) until the first date that recurrence or progressive disease was objectively documented.
- Progression Free Survival [ Time Frame: From start of study medication until progressive disease or death ]Defined as the time from the start of study medication until progressive disease or death from any cause during the study period.
- Overall Survival [ Time Frame: From time of start of study medication until death ]Defined as the time from the start of study medication until death from any cause.
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): NCT00100932
|United States, California|
|Gilroy, California, United States|
|United States, Florida|
|Ocala, Florida, United States|
|United States, Maryland|
|Baltimore, Maryland, United States|
|United States, Missouri|
|Columbia, Missouri, United States|
|St. Joseph, Missouri, United States|
|St. Louis, Missouri, United States|
|United States, Nebraska|
|McCook, Nebraska, United States|
|United States, Ohio|
|Canton, Ohio, United States|
|United States, Texas|
|Dallas, Texas, United States|
|Fort Worth, Texas, United States|
|United States, Virginia|
|Fairfax, Virginia, United States|
|Norfolk, Virginia, United States|
|United States, Washington|
|Vancouver, Washington, United States|
|Study Director:||Dale Shuster, Ph.D.||Eisai Inc.|