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

Non-Small-Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363766
• Other study ID #: 9813
• Secondary ID: H8K-MC-JZAC
• Status: Completed
• Phase: Phase 2
• Start date: September 2006
• Est. completion date: October 2008

Study information

• Verified date: March 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Intervention

Drug:
• LY573636-sodium
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.

Locations

Country	Name	City	State
Germany	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.	Gauting
Germany	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.	Großhansdorf
Germany	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.	Hamburg
Germany	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.	Loewenstein
Germany	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.	Mannheim
Italy	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.	Orbassano
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression	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.	First dose to measured progressive disease or death from study disease up to 10.35 months
Secondary	Progression-Free Survival	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.	First treatment dose to measured progressive disease or death from any cause up to 10.35 months
Secondary	Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)	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.	First treatment dose to measured progressive disease or death due to any cause up to 10.35 months
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of LY573636		Predose up to 2 hours postdose in Cycles 1 and 2 (21 days cycle)
Secondary	Overall Survival Time	Defined as the time from date of first dose to the date of death due to any cause.	First treatment dose to death due to any cause up to 25.23 months
Secondary	Duration of Response	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.	Time of response to progressive disease or death up to 10.35 months
Secondary	Duration of Stable Disease	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.	Time from documented stable disease or better to first date of progressive disease up to 10.35 months
Secondary	Number of Participants With Adverse Events (Safety)	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.	First treatment dose up to 25.23 months

External Links

•   Lilly Clinical Trial Registry