- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00363766
Study of LY573636-Sodium in Patients With Metastatic Non-Small Cell Lung Cancer
March 17, 2018 updated by: Eli Lilly and Company
A Phase 2 Study of LY573636-Sodium Administered as an Intravenous Infusion on Day 1 of a 21-Day Cycle as Third-line Treatment in Patients With Unresectable, Metastatic Non-Small Cell Lung Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gauting, Germany, D-82131
- 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.
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Großhansdorf, Germany, D-22927
- 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.
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Hamburg, Germany, D-21075
- 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.
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Loewenstein, Germany, 74245
- 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.
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Mannheim, Germany, 68167
- 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.
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Orbassano, Italy, 10043
- 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.
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San Sisto, Italy, 06156
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: LY573636
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A loading dose to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) or 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within these target ranges, intravenous, every 21 days until disease progression.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Progression
Time Frame: First dose to measured progressive disease or death from study disease up to 10.35 months
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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.
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First dose to measured progressive disease or death from study disease up to 10.35 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival
Time Frame: First treatment dose to measured progressive disease or death from any cause up to 10.35 months
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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.
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First treatment dose to measured progressive disease or death from any cause up to 10.35 months
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Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)
Time Frame: First treatment dose to measured progressive disease or death due to any cause up to 10.35 months
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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.
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First treatment dose to measured progressive disease or death due to any cause up to 10.35 months
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Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
Time Frame: Predose up to 2 hours postdose in Cycles 1 and 2 (21 days cycle)
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Predose up to 2 hours postdose in Cycles 1 and 2 (21 days cycle)
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Overall Survival Time
Time Frame: First treatment dose to death due to any cause up to 25.23 months
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Defined as the time from date of first dose to the date of death due to any cause.
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First treatment dose to death due to any cause up to 25.23 months
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Duration of Response
Time Frame: Time of response to progressive disease or death up to 10.35 months
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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.
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Time of response to progressive disease or death up to 10.35 months
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Duration of Stable Disease
Time Frame: Time from documented stable disease or better to first date of progressive disease up to 10.35 months
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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.
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Time from documented stable disease or better to first date of progressive disease up to 10.35 months
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Number of Participants With Adverse Events (Safety)
Time Frame: First treatment dose up to 25.23 months
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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.
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First treatment dose up to 25.23 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
August 10, 2006
First Submitted That Met QC Criteria
August 10, 2006
First Posted (Estimate)
August 15, 2006
Study Record Updates
Last Update Posted (Actual)
October 19, 2018
Last Update Submitted That Met QC Criteria
March 17, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9813
- H8K-MC-JZAC (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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