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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00078390
Recruitment Status : Completed
First Posted : February 26, 2004
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

Tracking Information
First Submitted Date  ICMJE February 24, 2004
First Posted Date  ICMJE February 26, 2004
Last Update Posted Date May 2, 2018
Actual Study Start Date  ICMJE February 2003
Actual Primary Completion Date September 28, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00078390 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The Phase 1 part of the study will determine the tolerable dose of S-3304 in the presence of radiation and paclitaxel/carboplatin chemotherapy in a non-randomized manner.

The Phase 2 part will compare the effect combination of S-3304 in addition to chemo-irradiation therapy to the effect of radiation and paclitaxel/carboplatin chemotherapy alone on small cell lung tumors

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non Small Cell Lung Cancer
  • Lung Cancer
  • Stage IIIA Non Small Cell Lung Cancer
  • Stage IIIB Non Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: S-3304
    S-3304 will be administered at the tolerable dose BID along with chemo-irradiation
  • Other: Chemo-irradiation
    Standard of care chemo-irradiation
Study Arms
  • Experimental: S-3304 plus chemo-irradiation
    The tolerable dose of S-3304 determined in the Phase 1 part of the study will be dosed BID along with a standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy
    Interventions:
    • Drug: S-3304
    • Other: Chemo-irradiation
  • Active Comparator: Chemo-irradiation
    The standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy will be administered
    Intervention: Other: Chemo-irradiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2018)
9
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
90
Actual Study Completion Date October 26, 2006
Actual Primary Completion Date September 28, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00078390
Other Study ID Numbers  ICMJE 0207P1421
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Shionogi Inc. ( Shionogi )
Study Sponsor  ICMJE Shionogi
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shionogi Inc.
Verification Date April 2018

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