E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00400829|
Recruitment Status : Completed
First Posted : November 17, 2006
Results First Posted : January 7, 2015
Last Update Posted : January 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer||Drug: eribulin mesylate||Phase 2|
I. Evaluate the antitumor activity of E7389 (eribulin mesylate), in terms of objective response rate, in patients with recurrent or progressive stage IIIB or IV non-small cell lung cancer.
II. Evaluate the time to progression and overall survival of patients treated with this drug.
III. Evaluate the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed once monthly for at least 6 months and then periodically thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of the Halichondrin B Analog E7389 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With a Taxane|
|Study Start Date :||November 2006|
|Primary Completion Date :||January 2011|
|Study Completion Date :||January 2011|
Experimental: Arm I
Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: eribulin mesylate
- Objective Response Rate (CR or PR) According to RECIST Criteria [ Time Frame: Tumor measurements repeated every 6 weeks ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
- Overall Survival [ Time Frame: From start of treatment to death from any cause, assessed up to 5 years ]Will be estimated using the product-limit method of Kaplan and Meier.
- Progression Free Survival [ Time Frame: From start of treatment to the time of documented progression, assessed up to 5 years ]Will be estimated using the product-limit method of Kaplan and Meier.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400829
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Barbara Gitlitz||City of Hope Medical Center|