Spots Global Cancer Trial Database for Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib
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Trial Identification
Brief Title: Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib
Official Title: A Phase Ib Open Label Clinical Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 Plus Sirolimus in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib
Study ID: NCT00993499
Conditions
Study Description
Brief Summary: The primary objective of this trial is to identify the Maximum Tolerated Dose of BIBW 2992 therapy when given continuously in combination with Sirolimus. The MTD will be based on the Dose Limiting Toxicity information collected during the first two cycles. Overall safety, pharmacokinetics and anti-tumour efficacy will be evaluated as secondary objectives.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
1200.70.34001 Boehringer Ingelheim Investigational Site, Badalona (Barcelona), , Spain
1200.70.34008 Boehringer Ingelheim Investigational Site, Barcelona, , Spain
1200.70.34009 Boehringer Ingelheim Investigational Site, Barcelona, , Spain
1200.70.34006 Boehringer Ingelheim Investigational Site, Girona, , Spain
1200.70.34007 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat (Barcelona), , Spain
1200.70.34005 Boehringer Ingelheim Investigational Site, Majadahonda (Madrid), , Spain
1200.70.34004 Boehringer Ingelheim Investigational Site, Valencia, , Spain
1200.70.34002 Boehringer Ingelheim Investigational Site, Zaragoza, , Spain
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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