« Return to News | Clinical Intelligence

Yakult initiates phase I trial in multiple myeloma with perifosine in Japan

Friday, June 29, 2012 12:12 PM

Aeterna Zentaris’ Japanese partner Yakult Honsha has initiated a phase I trial in multiple myeloma with perifosine, the company's oral Akt/PI3K inhibitor drug.

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."

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.