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Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Laboratorio Progenetica
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00956280
First received: August 10, 2009
Last updated: May 11, 2010
Last verified: May 2010

August 10, 2009
May 11, 2010
September 2009
April 2010   (final data collection date for primary outcome measure)
To analyze the frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLC. [ Time Frame: March 31, 2010 ] [ Designated as safety issue: No ]
To analyze the frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLC. [ Time Frame: January 31, 2010 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00956280 on ClinicalTrials.gov Archive Site
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Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer
Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer

The purpose of this study is to characterize the demographic and clinical aspects, and describe the frequency and type of KRAS mutation in a Brazilian population sample with advanced non-small cell lung cancer (NSCLC).

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Patients with Advanced Non Small Cell Lung Cancer

Non Small Cell Lung Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histological or cytological confirmation of locally advanced or metastatic Non Small Cell Lung Cancer (IIIB-IV)
  • Tumour sample (block of slides) available for KRAS analysis

Exclusion Criteria:

  • Confirmation of locally advanced or metastatic NSCLC (IIIB-IV) exclusively by cytology, with no tumour sample access.
  • Previous treatment using a MEK inhibitor or any other regimen containing docetaxel (previous treatment with paclitaxel is accepted)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00956280
NIS-OBR-DUM-2008/1, IMPACT 14829
No
MC MD, AstraZeneca
AstraZeneca
Laboratorio Progenetica
Study Director: José Eduardo Pipolo das Neves, MD AstraZeneca do Brasil, MC Medical Director
AstraZeneca
May 2010

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