BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma
Status:
Completed
Trial end date:
2016-05-25
Target enrollment:
Participant gender:
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.