Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

BIBW 2992

Dose escalation (19-40 patients): low or high dose oral + 12 addit. pat. at MTD, until progression or undue AEs

DRUG

Sirolimus (rapamycin)

Dose escalation (19-40 patients): several dose levels + 12 addit. pat. at MTD until progression or undue AEs.

Trial Locations (8)

Unknown

1200.70.34001 Boehringer Ingelheim Investigational Site, Badalona (Barcelona)

1200.70.34008 Boehringer Ingelheim Investigational Site, Barcelona

1200.70.34009 Boehringer Ingelheim Investigational Site, Barcelona

1200.70.34006 Boehringer Ingelheim Investigational Site, Girona

1200.70.34007 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat (Barcelona)

1200.70.34005 Boehringer Ingelheim Investigational Site, Majadahonda (Madrid)

1200.70.34004 Boehringer Ingelheim Investigational Site, Valencia

1200.70.34002 Boehringer Ingelheim Investigational Site, Zaragoza

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT00993499 - Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib | Biotech Hunter | Biotech Hunter