BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma
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.
Timeline
- Start
- 2008-07-14
- Primary completion
- 2011-05-12
- Completion
- 2016-05-25
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Phase II - Temozolomide 75mg/m^2 vs Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2; p = 0.148; z-test; note: P-value is from an approximate normal test for the 6 month time point. NCT00727506 ↗
registry analysis (superiority or other test); Phase II - Temozolomide 75mg/m^2 vs Phase II - Afatinib 40mg; p = 0.008; z-test; note: P-value is an approximate normal test for the six month time point. NCT00727506 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afatinib | Small molecule | — | — |
| Comparator | TMZ | Unknown | — | — |
| Comparator | TMZ | Unknown | — | — |