Apogenix is developing APG101 for the treatment of glioblastoma. The present clinical study is a randomized, controlled open-label phase II trial comparing the efficacy of a combination therapy of intravenous APG101 weekly plus reirradiation versus a single reirradiation. Patients were eligible for inclusion if they suffered from first or second relapse or progression of glioblastoma and if they were treated with Temozolomide and a radiotherapy (at least 8 month ago). The study is still ongoing with treatment of recruited patients (patients can participate in this study until disease progression). Clinical endpoints of this trial include progression-free survival after 6 month (PFS6) and overall survival.
Recruitment was completed in September 2011 with inclusion of 84 patients. Participating countries were Germany, Austria and Russia. Further information about the trial can be found on the following webpage: www.clinicaltrials.gov