Afatinib and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2

PHASE1CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
Neoplasms
Interventions
DRUG

BIBW 2992 low (20mg) dosage

Patients will receive 20mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.

DRUG

BIBW 2992 medium (40mg) dosage

Patients will receive 40mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.

DRUG

BIBW 2992 high (50mg) dosage

Patients will receive 50mg dosage of BIBW 2992 plus standard dosage of vinorelbine.

DRUG

Vinorelbine per os 60 mg/m²

Patients will receive 60 mg/m² Vinorelbine per os at J1 J8 and J15

DRUG

Vinorelbine per os 80 mg/m²

Patients will receive 80 mg/m² Vinorelbine per os at J22

DRUG

Vinorelbine i.v. 25 mg/m²

Patients will receive 25 mg/m² of Vinorelbine i.v.

Trial Locations (2)

Unknown

1200.69.3301 Boehringer Ingelheim Investigational Site, Toulouse

1200.69.3302 Boehringer Ingelheim Investigational Site, Villejuif

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT00906698 - Afatinib and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2 | Biotech Hunter | Biotech Hunter