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Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01163058
Recruitment Status : Unknown
Verified July 2010 by Istituto Clinico Humanitas.
Recruitment status was:  Active, not recruiting
First Posted : July 15, 2010
Last Update Posted : July 29, 2010
Sponsor:
Information provided by:
Istituto Clinico Humanitas

Tracking Information
First Submitted Date June 29, 2010
First Posted Date July 15, 2010
Last Update Posted Date July 29, 2010
Study Start Date June 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2010)
Determine the incidence of EGFR (Epidermal growth factor ) and KRAS (Kirsten ras sarcoma viral oncogene homolog ) mutations in 300 NSCLC (non small cell lung cancer) patients treated with gefitinib or erlotinib [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01163058 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 14, 2010)
Investigate the association of clinical features such as sex, age, smoking history and histology with oncogenic alterations. [ Time Frame: 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer
Official Title Retrospective Analysis Evaluating Molecular Factors of Primary Resistance to Tyrosine Kinase Inhibitors in Metastatic Non Small Cell Lung Cancer Patients
Brief Summary Aim of the present retrospective study is to evaluate molecular factors of primary resistance to tyrosine kinase inhibitors in metastatic non small cell lung cancer (NSCLC) patients. The investigators assess first, the incidence of epidermal growth factor receptor (EGFR) and Kirsten ras sarcoma viral oncogene homolog (KRAS) mutations, SOS and hepatocyte growth factor (HGF) expression, anaplastic lymphoma kinase (ALK) translocation and expression and, secondly, the investigators correlate molecular markers with clinical features and outcome in terms of response rate, progression free survival and overall survival.
Detailed Description Non small cell lung cancer patients.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population non small cell lung cancer patients treated with gefitinib or erlotinib
Condition Non Small Cell Lung Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Unknown status
Estimated Enrollment
 (submitted: July 14, 2010)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2011
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of NSCLC (non small cell lung cancer) with available tumor tissue for mutational analysis
  • Metastatic disease treated with gefitinib or erlotinib
  • Presence of at least one measurable lesion according to RECIST criteria

Exclusion Criteria:

  • No tumor tissue available
  • No clinical data available
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01163058
Other Study ID Numbers ONC/OSS-01/2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Armando Santoro, MD, Istituto Clinico Humanitas
Study Sponsor Istituto Clinico Humanitas
Collaborators Not Provided
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
PRS Account Istituto Clinico Humanitas
Verification Date July 2010