Study of LY573636-Sodium in Patients With Metastatic Non-Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Non-Small-Cell Lung Cancer
• Interventions: Drug: LY573636-sodium

• Registration Number: NCT00363766
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The primary objective is to estimate the time to progressive disease for patients who receive LY573636-sodium (hereafter referred to as LY573636) after two previous treatments for metastatic non-small cell lung cancer. Patients will receive an intravenous infusion of study drug once every 21 days. Computed tomography (CT)-scans will be done before the first dose and then after every other treatment.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-08-10
• Study First Submitted QC: 2006-08-10
• Study First Posted: 2006-08-15
• Study Start: 2006-09
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Disposition First Submitted: 2009-10-16
• Disposition First Submitted QC: 2009-10-16
• Disposition First Posted: 2009-10-19
• Status Verified: 2018-03
• Results First Submitted: 2018-03-17
• Results First Submitted QC: 2018-03-17
• Last Update Submitted: 2018-03-17
• Results First Posted: 2018-10-19
• Last Update Posted: 2018-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Diagnosis of metastatic non-small-cell lung cancer
• At least 18 years of age
• Have received 2 previous treatment regimens for metastatic non-small-cell lung cancer

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Exclusion Criteria

• Serious pre-existing medical conditions
• Previous cancer (except skin cancer, excluding melanoma)
• Have received 3 or more previous treatment regimens for metastatic non- small-cell lung cancer
• Active treatment with Coumadin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY573636	LY573636-sodium	-

Primary Outcome Measures

Name	Time	Method
Time to Progression	First dose to measured progressive disease or death from study disease up to 10.35 months	Defined as the time from date of first dose to the first observation of progression of disease (PD) or death from study disease. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival	First treatment dose to measured progressive disease or death from any cause up to 10.35 months	Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)	First treatment dose to measured progressive disease or death due to any cause up to 10.35 months	Objective response rate is the percentage of participants with complete response (CR) + partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Duration of Response	Time of response to progressive disease or death up to 10.35 months	The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression of disease or death due to any cause. CR or PR is classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.
Duration of Stable Disease	Time from documented stable disease or better to first date of progressive disease up to 10.35 months	Duration of stable disease (SD) is defined from date of documented SD or better to first date of progression of disease (PD) (assessed every cycle during study therapy, or every 2 months during post-therapy until PD). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636	Predose up to 2 hours postdose in Cycles 1 and 2 (21 days cycle)
Overall Survival Time	First treatment dose to death due to any cause up to 25.23 months	Defined as the time from date of first dose to the date of death due to any cause.
Number of Participants With Adverse Events (Safety)	First treatment dose up to 25.23 months	Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇮🇹 San Sisto, Italy