BIBW 2992 (Afatinib) and Vinorelbine in Japanese Patients With Advanced Solid Tumours

An Open-label Phase I Study of Once Daily Oral Treatment With BIBW 2992 in Combination With Weekly Vinorelbine Intravenous Injection in Japanese Patients With Advanced Solid Tumours

• To identify the Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine i.v. by assessment of Dose Limiting Toxicities (DLT);
• To assess safety and anti-tumour efficacy and determine pharmacokinetic characteristics of afatinib and vinorelbine i.v.

Inclusion criteria:

• Histologically confirmed diagnosis of malignancy that is advanced and for which standard therapies do not exist or are no longer effective.
• Life expectancy at least 12 weeks
• Eastern Cooperative Oncology Group Performance Status 0 or 1
• Adequate hepatic, renal, haematologic and other organ function
• Written informed consent

Exclusion criteria:

• Chemotherapy, immunotherapy, surgery and radiotherapy within the past 4 weeks
• Prior treatment with afatinib and or vinorelbine
• Clinically significant active infectious disease