Iressa 2nd Line Phase III Study in Japan

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252707
First received: November 14, 2005
Last updated: December 14, 2007
Last verified: December 2007

November 14, 2005
December 14, 2007
September 2003
Not Provided
Determine the overall survival with these treatments as the primary outcome.
Same as current
Complete list of historical versions of study NCT00252707 on ClinicalTrials.gov Archive Site
  • Determine the followings as the secondary outcome variables:
  • - Progression-free survival (PFS)
  • - Time to treatment failure (TTF)
  • - Objective tumour response (CR, PR) and the disease control rate (CR, PR, SD [≥12 weeks]) based on the RECIST guidelines
  • - Lung cancer subscale (LCS)
  • - QOL according to FACT-L questionnaire
  • - Frequency and severity of adverse events.
  • Determine the followings as the exploratory outcome variables:
  • - Biomarkers related to expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways
  • - Biomarkers related to somatic (non-inheritable) mutation analyses of genes of the ErbB family, their signalling pathways and associated pathways which are thought to be influenced by gefitinib in tumour cells.
Same as current
Not Provided
Not Provided
 
Iressa 2nd Line Phase III Study in Japan
A Multicentre, Randomised, Open-Label, Parallel-Group, Phase III Post-Marketing Clinical Study to Compare the Overall Survival Between Gefitinib and Docetaxel in Patients With Advanced or Metastatic (Stage IIIB/IV), or Recurrent Non-Small Cell Lung Cancer, Who Have Failed One or Two Chemotherapy Regimens

In this study, among the patients with non-small cell lung cancer, those with metastasis or recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and we will compare the effectiveness and safety of gefitinib with docetaxel.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
Drug: Gefitinib or Docetaxel
Not Provided
Maruyama R, Nishiwaki Y, Tamura T, Yamamoto N, Tsuboi M, Nakagawa K, Shinkai T, Negoro S, Imamura F, Eguchi K, Takeda K, Inoue A, Tomii K, Harada M, Masuda N, Jiang H, Itoh Y, Ichinose Y, Saijo N, Fukuoka M. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol. 2008 Sep 10;26(26):4244-52.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
484
November 2006
Not Provided

Inclusion Criteria:

  • You are "histologically" or "cytologically" confirmed to have recurrent or metastatic NSCLC
  • You have been treated with chemotherapy including platinums for NSCLC.

Exclusion Criteria:

  • You have received treatment for non-small lung cancer within 4 weeks before your participation in this study (except for specific therapies)
  • You have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, pulmonary pneumonia, or pneumoconiosis evident on the X-ray
  • You have or had any disease of radiation pneumonia or drug-induced pneumonia, which requires treatment with corticosteroids
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00252707
D791AL00001, V-15-32
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Japan Medical Director, MD AstraZeneca
AstraZeneca
December 2007

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