Afatinib and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2

Phase I Open Label Trial to Assess Safety of BIBW 2992 With Vinorelbine in Solid Tumors Known to Overexpress HER2 and/or EGFR

To determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of oral BIBW 2992 in combination with intravenous or oral vinorelbine

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.