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Results of G004, a phase IIb actively controlled clinical trial with the TGF-b2 targeted compound AP 12009 for recurrent anaplastic astrocytoma.
Sub-category: CNS Tumors
Category: Central Nervous System Tumors
Meeting: 2006 ASCO Annual Meeting
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Abstract No: 1566
Citation: Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 1566
Author(s): P. Hau, G. Stockhammer, M. Kunst, A. Mahapatra, K. V. Sastry, V. E. Parfenov, V. G. Leshinsky, P. Jachimczak, U. Bogdahn, K. Schlingensiepen, AP 12009 study group
Abstract: Background: In 3 phase I/II dose-escalation studies the TGF-β2 specific compound AP 12009 proved to be well tolerated and revealed an excellent safety profile. Furthermore, antitumor activity including complete tumor remissions was observed. Methods: G004 is an international open-label, actively controlled, dose finding phase IIb trial in adult patients with histopathologically confirmed recurrent high-grade glioma. 145 patients with recurrent anaplastic astrocytoma (AA, WHO grade III) or glioblastoma (GBM, WHO grade IV) were enrolled into the study. Objective of the current phase IIb study is to compare the efficacy and safety of two doses of AP 12009 and standard treatment. Patients were randomized to receive either one of two doses of AP 12009 (10 µM or 80 µM) or standard chemotherapy (TMZ or PCV). AP 12009 was administered intratumorally by CED. 134 patients received treatment and all of them have completed active treatment. Primary endpoint is tumor response by local and central MRI reading and survival. Results: Here we report on patients with recurrent AA (for GBM see separate Abstract). 38 patients with AA (68% male, 32% female; median age 39, range 22-60; median Karnofsky performance status: 90, range 70-100) were treated. 26 patients received AP 12009 (10 µM or 80 µM), 12 patients were treated with TMZ or PCV. Up to now, in 89 patients treated with AP 12009 (both AA and GBM patients) 6 SAEs possibly related to the study drug and 37 procedure related SAEs (92% mild or moderate) were documented. Partial and complete tumor responses were observed. Exact response rates will be determined after central MRI reading is completed. Responses in the AP 12009 groups are long lasting. The results confirm the good safety profile of AP 12009 as well as the efficacy data seen in phase I studies. The median overall survival is not yet reached. Conclusions: The long-term tumor free survival of several patients may actually hint towards a potential to cure some patients with this devastating disease. Phase III clinical trials in both AA and GBM patients are currently in preparation.
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