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

Phase 2

Completed

• Conditions: Non-Small-Cell Lung Carcinoma
• Interventions: Drug: E7389 28 Day Cycle; Drug: E7389 21 Day Cycle

• Registration Number: NCT00100932
• Lead Sponsor: Eisai Inc.

Brief Summary

This is a study of E7389 in patients with recurrent and/or metastatic Non-Small-Cell Lung Cancer (NSCLC) who progressed during or after treatment with a platinum agent and another chemotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-01-07
• Study First Submitted QC: 2005-01-07
• Study First Posted: 2005-01-10
• Primary Completion: 2008-06
• Results First Submitted: 2011-12-26
• Results First Submitted QC: 2011-12-26
• Results First Posted: 2012-01-31
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-22
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	E7389 28 Day Cycle	E7389 28 day cycle
2	E7389 21 Day Cycle	E7389 21 day cycle

Primary Outcome Measures

Name	Time	Method
Overall Objective Response Rate (ORR)	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).

Secondary Outcome Measures

Name	Time	Method
Duration of Response	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	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	From time of start of study medication until death	Defined as the time from the start of study medication until death from any cause.