Glioma Clinical Trial
Official title:
Phase I/II Trial of BIBW 2992 (Afatinib) in Treating Patients With Recurrent Glioblastoma Multiforme
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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