Conditions: Neoplasms
Allocation: NON_RANDOMIZED | Intervention model: 
Enrollment: 47
Healthy volunteers: no

Brief summary:
Study to determine the maximum tolerated dose of BIBW 2992 when combined with backbone chemotherapies consisting in cisplatin plus paclitaxel or cisplatin plus 5 FU.

The overall safety, the pharmacokinetics and the anti-tumour efficacy will also be assessed.

Detailed description:

Arms:
arm 1: daily oral dose of BIBW 2992 combined with 3-weekly infusion of cisplatin-paclitaxel arm 2: daily oral dose of BIBW 2992 combined with 3-weekly infusion of cisplatin-5FU

Interventions: intervention 1: BIBW 2992 intervention 2: BIBW 2992
Intervention descriptions: intervention 1: In each arm, BIBW 2992 dose will be escalated to determine MTD. Starting dose will be 20mg daily followed by 40 mg (with the option of an intermediary dose of 30 mg) then 50mg daily. Dose escalation will stop at 50 mg. No intra patient dose escalation. intervention 2: low to high dose, daily

Protocol document: