« Return to News | Clinical Intelligence

Trial Results: Oncology

Wednesday, October 1, 2008 07:55 AM

PharmaMar reported positive results from a phase III trial of Yondelis for the treatment of ovarian cancer. This randomized study enrolled 627 women with ovarian cancer who had relapsed after receiving standard first-line chemotherapy, across several international sites.

The subjects received Yondelis in combination with Doxil (pegylated liposomal doxorubicin) or Doxil alone. The primary endpoint, progression-free survival, was reached with statistical significance. Median progression-free survival was 7.3 months for subjects who received the combination of Yondelis and Doxil versus 5.8 months for those treated with Doxil alone (p=0.019), for a clinically meaningful 21% reduction in the risk of progression or death. There was an increased response rate with the Yondelis and Doxil combination of 28% versus Doxil alone (19%), as measured by a blinded radiology review.

The secondary endpoint of overall survival has not been determined, however a positive trend with a 15% reduction in the risk of death favored the Yondelis and Doxil treatment group. Treatment was generally well tolerated.

Based on the results, PharmaMar and plans to file an MAA with the EMEA and, with their U.S partner, an NDA with the FDA, both before the end of 2008.

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.