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BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma
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.
Details
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | PHASE2 |
| Status | COMPLETED |
| Enrolment | 151 |
| Start date | Mon Jul 14 2008 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed May 25 2016 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Glioma
Interventions
- BIBW 2992
- TMZ
- BIBW 2992 plus TMZ
Countries
Canada, United States