Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.ImClone Systems has reached agreement with the FDA under a special protocol assessment for its planned Phase III clinical trial of the company's anti-vascular endothelial growth factor receptor-2 monoclonal antibody IMC-1121B in women with metastatic breast cancer.
Subscribe to our email newsletter
Pursuant to the special protocol assessment, this Phase III trial will be a randomized, double-blind, placebo-controlled trial of IMC-1121B plus docetaxel in women with unresectable locally-recurrent or metastatic breast cancer who have not received prior chemotherapy in the locally-recurrent or metastatic setting.
The trial, which will be conducted under the auspices of the Cancer International Research Group, doing business as Translational Research in Oncology, is expected to enroll approximately 1,100 patients who will be randomized (2:1) to receive either IMC-1121B plus docetaxel or placebo plus docetaxel.
The primary endpoint of the trial will be progression-free survival. The trial will be conducted at more than 200 sites throughout the world. Patient enrollment is expected to begin in the third quarter of 2008.
Eric Rowinsky, executive vice president and chief medical officer of ImClone, said: “Our commitment to this accelerated developmental strategy of IMC-1121B is based on its antitumor activity and favorable safety and pharmacologic profiles noted in early clinical trials.”