Conditions: Glioma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 151
Healthy volunteers: no

Brief summary:
Phase I Part: To determine the maximum tolerated dose (MTD) and pharmacokinetics of BIBW 2992 administered in combination with TMZ in patients with recurrent malignant gliomas (WHO Grade III and IV).

Phase II Part: To estimate the efficacy and safety of BIBW 2992 monotherapy and BIBW 2992 / TMZ combination therapy compared to TMZ monotherapy (three treatment arms) in patients with recurrent GBM. To evaluate molecular determinants of response to BIBW 2992.

Detailed description:

Arms:
arm 1: BIBW 2992 once daily arm 2: TMZ 21/28 days arm 3: BIBW 2992 once daily plus TMZ 21/28 days

Interventions: intervention 1: BIBW 2992 intervention 2: TMZ intervention 3: BIBW 2992 plus TMZ
Intervention descriptions: intervention 1: BIBW 2992 once daily intervention 2: TMZ 21/28 intervention 3: BIBW 2992 once daily plus TMZ 21/28 days

Protocol document: