Trial Information
Phase I Open Label Trial to Assess Safety of BIBW 2992 With Vinorelbine in Solid Tumors Known to Overexpress HER2 and/or EGFR
Inclusion Criteria
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.
- Prior treatment with HER2 inhibiting drugs within the past two weeks before the start
of therapy or concomitantly with this trial.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To identify the MTD of BIBW 2992 therapy in combination with vinorelbine i.v. and vinorelbine oral.
Outcome Time Frame:
28 days
Safety Issue:
No
Principal Investigator
Boehringer Ingelheim
Investigator Role:
Study Chair
Investigator Affiliation:
Boehringer Ingelheim Pharmaceuticals
Authority:
France: AFFSAPS
Study ID:
1200.69
NCT ID:
NCT00906698
Start Date:
May 2009
Completion Date:
January 2013
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