Clinical trial NCT00363766: Study of LY573636-Sodium in Patients With Metastatic Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small-Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Progression
timeFrame: First dose to measured progressive disease or death from study disease up to 10.35 months
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: First treatment dose to measured progressive disease or death from any cause up to 10.35 months
measure: Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)
timeFrame: First treatment dose to measured progressive disease or death due to any cause up to 10.35 months
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
timeFrame: Predose up to 2 hours postdose in Cycles 1 and 2 (21 days cycle)
measure: Overall Survival Time
timeFrame: First treatment dose to death due to any cause up to 25.23 months
measure: Duration of Response
timeFrame: Time of response to progressive disease or death up to 10.35 months
measure: Duration of Stable Disease
timeFrame: Time from documented stable disease or better to first date of progressive disease up to 10.35 months
measure: Number of Participants With Adverse Events (Safety)
timeFrame: First treatment dose up to 25.23 months
Other outcomes:
Locations:
city: Gauting
country: Germany
facility: 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.
city: Großhansdorf
country: Germany
facility: 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.
city: Hamburg
country: Germany
facility: 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.
city: Loewenstein
country: Germany
facility: 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.
city: Mannheim
country: Germany
facility: 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.
city: Orbassano
country: Italy
facility: 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.
city: San Sisto
country: Italy
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: