Conditions: Neoplasms
Allocation: NON_RANDOMIZED | Intervention model: 
Enrollment: 57
Healthy volunteers: no

Brief summary:
The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD) in terms of safety and tolerability of the combination of BI 6727 with BIBW 2992, in patients with advanced or metastatic solid tumours. Dosages of both BI 6727 and BIBW 2992 will be varied to establish the MTD of the combination. Two combination treatment schedules will be tested, the MTD of each combination will be determined.

Secondary objectives are the exploration of pharmacokinetics, overall safety and preliminary efficacy.

Detailed description:

Arms:
arm 1: patients receive increasing doses of BI 6727 in combination with increasing doses of BIBW 2992

Interventions: intervention 1: BI 6727 + BIBW 2992
Intervention descriptions: intervention 1: BI 6727 administered i.v. every 21 days + BIBW 2992 given orally once a day

Protocol document: