Open Label Trial to Explore Safety of Combining Afatinib (BIBW 2992) and Radiotherapy With or Without Temozolomide in Newly Diagnosed Glioblastoma Multiform

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

September 17, 2009

Primary Completion Date

September 12, 2017

Study Completion Date

September 12, 2017

Conditions
Glioblastoma
Interventions
DRUG

Temozolomide

During RT: 75 mg/m2 daily , 4 weeks after RT: given days 1 to 5 of 28 day cycles (150 mg/m2 in cycle 1, 200 mg/m2 in cycle 2 up to cycle 6)

PROCEDURE

Radiotherapy

Day 1 to day 42

DRUG

BIBW2992

Escalating dose cohorts during Radiotherapy(RT) period, fixed dose after RT

PROCEDURE

Radiotherapy

Day 1 to day 42

DRUG

BIBW2992

Escalating dose cohorts during Radiotherapy(RT) period , fixed dose after RT

Trial Locations (5)

CB2 0QQ

Addenbrooke's Hospital, Cambridge

DD1 9SY

Ninewells Hospital & Medical School, Dundee

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

M20 4BX

The Christie Hospital, Manchester

SM2 5PT

The Royal Marsden Hospital, Sutton

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT00977431 - Open Label Trial to Explore Safety of Combining Afatinib (BIBW 2992) and Radiotherapy With or Without Temozolomide in Newly Diagnosed Glioblastoma Multiform | Biotech Hunter | Biotech Hunter