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Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Study NCT00078390   Information provided by Shionogi
First Received: February 24, 2004   Last Updated: June 23, 2005   History of Changes

February 24, 2004
June 23, 2005
February 2003
 
 
 
Complete list of historical versions of study NCT00078390 on ClinicalTrials.gov Archive Site
 
 
 
Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer
A Phase I/II Study of the Safety, Pharmacokinetic Interaction and Efficacy of S-3304 in Combination With Standard Therapy in Patients With Locally Advanced Non-Small Cell Lung Cancer.

A study to measure the safety and effectiveness of S-3304 when given in combination with conventional chemo-radiation therapy in patients with locally advanced non-small cell lung cancer.

A two part study to evaluate the safety and efficacy of S-3304 in combination with standard therapy in patients with locally advanced non-small cell lung cancer. The first part of the study is a Phase I design to evaluate the maximum tolerated dose of S-3304 when given in combination with radiation and paclitaxel/carboplatin chemotherapy that is appropriate for further evaluation. The second part of the study is a randomized Phase II design to evaluate the efficacy of recommended S-3304 dose in combination with chemo-radiation.

Phase I, Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
  • Non Small Cell Lung Cancer
  • Lung Cancer
  • Stage IIIA Non Small Cell Lung Cancer
  • Stage IIIB Non Small Cell Lung Cancer
Drug: S-3304
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
90
 
 

INCLUSION CRITERIA

  • newly diagnosed non-small cell lung cancer of stage IIIA non-resectable or of stage IIIB without pleural effusion
  • ECOG performance status 0-1
  • adequate organ function
  • clinically indicated and able to receive conventional chemoradiation therapy

EXCLUSION CRITERIA

  • patients with prior history of cancer, other than basal cell carcinoma after appropriate treatment, or prior systemic chemotherapy treatment
  • patients with other serious intercurrent illness including HIV/AIDS, or contraindicated for paclitaxel/carboplatin or thoracic irradiation treatment
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00078390
 
0207P1421
Shionogi
 
 
Shionogi
December 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP