Study to Determine the Maximum Tolerated Dose of BIBW 2992 (Afatinib) When Combined With Cisplatin/Paclitaxel or Cisplatin/5-FU in Patients With Advanced Solid Tumours

PHASE1CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

July 1, 2008

Primary Completion Date

July 1, 2010

Study Completion Date

July 1, 2010

Conditions
Neoplasms
Interventions
DRUG

BIBW 2992

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.

DRUG

BIBW 2992

low to high dose, daily

Trial Locations (3)

Unknown

1200.37.3202 Boehringer Ingelheim Investigational Site, Brussels

1200.37.3201 Boehringer Ingelheim Investigational Site, Edegem

1200.37.3203 Boehringer Ingelheim Investigational Site, Ghent

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY