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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 01, 2014