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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00363766
First received: August 10, 2006
Last updated: October 16, 2009
Last verified: October 2009
  Purpose

The primary objective is to estimate the time to progressive disease for patients who receive 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. CT-scans will be done before the first dose and then after every other treatment.


Condition Intervention Phase
Non-Small-Cell Lung Cancer
Drug: LY573636
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of LY573636 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Time to progression [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: Cycle 1 through Cycle 6 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: time of response to time of progressive disease ] [ Designated as safety issue: No ]
  • Duration of stable disease [ Time Frame: baseline to time of measured progressive disease ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: September 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: LY573636
A loading dose to target 380 micrograms/ml Cmax followed by a lower chronic dose to maintain Cmax within this target range, IV, every 21 days until disease progression.
Other Name: tasisulam

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00363766

Locations
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, 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.
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.
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.
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.
Mannheim, Germany, 68167
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, 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.
San Sisto, Italy, 06156
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00363766     History of Changes
Other Study ID Numbers: 9813, H8K-MC-JZAC
Study First Received: August 10, 2006
Last Updated: October 16, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 14, 2014