Conditions: Neoplasms
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 55
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: Daily low (20mg), medium (40mg) and high (50mg) dosages of BIBW 2992 with standard dosage of vinorelbine i.v. arm 2: Daily low (20mg), medium (40mg) and high (50mg) dosages of BIBW 2992 with standard dosage of vinorelbine per os.

Interventions: intervention 1: BIBW 2992 low (20mg) dosage intervention 2: BIBW 2992 medium (40mg) dosage intervention 3: BIBW 2992 high (50mg) dosage intervention 4: Vinorelbine per os 60 mg/m² intervention 5: Vinorelbine per os 80 mg/m² intervention 6: Vinorelbine i.v. 25 mg/m²
Intervention descriptions: intervention 1: Patients will receive 20mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine. intervention 2: Patients will receive 40mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine. intervention 3: Patients will receive 50mg dosage of BIBW 2992 plus standard dosage of vinorelbine. intervention 4: Patients will receive 60 mg/m² Vinorelbine per os at J1 J8 and J15 intervention 5: Patients will receive 80 mg/m² Vinorelbine per os at J22 intervention 6: Patients will receive 25 mg/m² of Vinorelbine i.v.

Protocol document: