Status:
COMPLETED
Afatinib and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of oral BIBW 2992 in combination with intravenous or oral vinorelbine
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically or cytologically confirmed diagnosis of malignancy that is now advanced, non resectable and/or metastatic
- Tumours historically known to overexpress EGFR and/or HER2
- Exclusion criteria:
- Prior treatment with HER2 inhibiting drugs within the past 4 weeks before the start of therapy or concomitantly with this trial.
- Prior treatment with EGFR inhibiting drugs within the past two weeks before the start of therapy or concomitantly with this trial.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00906698
Start Date
June 1 2009
End Date
January 1 2013
Last Update
June 9 2014
Active Locations (2)
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1
1200.69.3301 Boehringer Ingelheim Investigational Site
Toulouse, France
2
1200.69.3302 Boehringer Ingelheim Investigational Site
Villejuif, France