Yakult initiates phase I trial in multiple myeloma with perifosine in Japan
Friday, June 29, 2012
Yakult, who is sponsoring and conducting the trial in Japan, reported that the first patient has been dosed with perifosine.
The open-label, two step phase I trial in which perifosine is combined with bortezomib (Velcade) and dexamethasone in patients with refractory multiple myeloma who have previously been treated with bortezomib. The trial is expected to include a total of 18 patients (6 in step one and 12 in step two). Patients will receive perifosine daily (50mg, Days 1-21) in combination with bortezomib (1.3 mg/m, Days 1, 4, 8 and 11) and dexamethasone (20mg, Days 1, 2, 4, 5, 8, 9,
11 and 12) according to a three-week cycle (21 days ± 3 days). The primary endpoint is safety while secondary endpoints include response rate, progression-free survival, and time to tumor progression.
“We would like to thank our partner Yakult for their close collaboration in initiating this important phase I trial in multiple myeloma which is necessary at this time in order to comply with Japan’s specific registration requirements,” said Juergen Engel, PhD, president and CEO of Aeterna Zentaris. “Perifosine [is] also currently in a phase III trial in other parts of the world in multiple myeloma—for which we expect to reach an interim analysis in the first quarter of next year.”