Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer - Tabular View

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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. Last updated on June 23, 2005. Information provided by Shionogi

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer
Official Title ^†	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.
Brief Summary	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.
Detailed Description	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.
Study Phase	Phase I, Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Non Small Cell Lung Cancer Lung Cancer Stage IIIA Non Small Cell Lung Cancer Stage IIIB Non Small Cell Lung Cancer
Intervention ^†	Drug: S-3304
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	90
Start Date ^†	February 2003
Completion Date
Eligibility Criteria ^†	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
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00078390
Organization ID	0207P1421
Secondary IDs ^††
Study Sponsor ^†	Shionogi
Collaborators ^††
Investigators ^†
Information Provided By	Shionogi
Verification Date	December 2004
First Received Date ^†	February 24, 2004
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.