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

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ClinicalTrials.gov Identifier: NCT00363766
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : October 19, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:
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 or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Drug: LY573636 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Time to progression [ Time Frame: baseline to measured progressive disease ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: baseline to measured progressive disease ]
  2. Objective response rate [ Time Frame: baseline to measured progressive disease ]
  3. Pharmacokinetics [ Time Frame: Cycle 1 through Cycle 6 ]
  4. Overall survival [ Time Frame: baseline to date of death from any cause ]
  5. Duration of response [ Time Frame: time of response to time of progressive disease ]
  6. Duration of stable disease [ Time Frame: baseline to time of measured progressive disease ]
  7. Safety [ Time Frame: every cycle ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Chief Medical Officer, Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00363766     History of Changes
Other Study ID Numbers: 9813
H8K-MC-JZAC
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: October 19, 2009
Last Verified: October 2009

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