AMP: Phase I/II study of AMG 102 and panitumumab in recurrent Glioblastoma Multiforme (GBM)

The purpose of this study is to investigate the effectiveness of a combination of two drugs, called AMG 102 and panitumumab, for patients with brain tumours that have returned after previous treatment. In addition, the study will investigate the side-effects that might be associated with the combination of these two drugs when treating brain tumours. Research has shown that AMG 102 is effective at treating brain tumours in a small proportion of patients, and preliminary results in the laboratory show that panitumumab could make AMG 102 more effective at treating brain tumours. Therefore this study will be testing this combination of drugs. The combination of AMG 102 and panitumumab has previously been tested in 8 patients with bowel cancer, and is continuing to be tested in an ongoing bowel cancer study, but has not previously been tested in patients with brain tumours. Because very few patients have been treated with the combination of AMG 102 and panitumumab, the study will be conducted in two phases. Initially 3 patients will be treated at least one week apart. Once these 3 patients have completed 4 weeks of treatment each, and if there are no concerns with side effects, a further 3 patients will be treated at the same dose. If unacceptable side effects are observed, a lower dose will be tested, again treating 3 patients at least one week apart. If unacceptable side effects are still observed at the lower dose, an even lower dose will be tested. Using this system, the dose for the second phase will be identified, or if an acceptable dose cannot be identified, the study will not continue. A total of 6 to 18 patients will participate in the first phase of the study. The second phase of the study will enrol patients until a total of 42 patients have been treated at the dose identified in the first phase.