Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 To...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Pathologically or cytologically confirmed diagnosis of Stage IIIB or Stage IV NSCLC
- Patients who have failed conventional treatment (at least 1 prior treatment line), or for whom no therapy of proven efficacy exists
- Patients whose tumors:
- are EGFR mutation-positive or
- are EGFR mutation-negative or unknown provided they had disease progression after achieving either response or stable disease for at least 6 months from a previous treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
- Patients aged 18 years or older
- Life expectancy of at least three (3) months
- Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0-2
- Written informed consent that is consistent with ICH-GCP guidelines
- Exclusion criteria:
- Prior major surgery, chemotherapy or radiation therapy within 4 weeks before start of therapy.
- Prior treatment with an mTOR inhibitor within the past 4 weeks before start of therapy or concomitantly with this study
- Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of run-in treatment with Sirolimus
- Active CNS metastases (defined as stable for \<4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants or steroids)
- Severe alteration in serum fasting cholesterol (equal or more than 350 mg/dL) or triglycerides (equal or more than 400 mg/dL). Patients may be allowed to enrol on the trial after initiation of lipid lowering agents.
- Requirement for treatment with any of the prohibited concomitant medications:
- Concomitant CYP3A4 inhibitors within the past 7 days before start of therapy or concomitantly with this study.
- Concomitant CYP3A4 inducers within the past 14 days before start of therapy or concomitantly with this study.
- Any contraindications for therapy with Sirolimus.
- Known hypersensitivity to BIBW 2992, Sirolimus or other rapamycin analogues (everolimus, temsirolimus, deforolimus, etc.) or the excipients of any of the trial drugs.
- Use of any investigational drug within 4 weeks before start of therapy.
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00993499
Start Date
October 1 2009
End Date
September 1 2014
Last Update
October 7 2015
Active Locations (8)
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1
1200.70.34001 Boehringer Ingelheim Investigational Site
Badalona (Barcelona), Spain
2
1200.70.34008 Boehringer Ingelheim Investigational Site
Barcelona, Spain
3
1200.70.34009 Boehringer Ingelheim Investigational Site
Barcelona, Spain
4
1200.70.34006 Boehringer Ingelheim Investigational Site
Girona, Spain