This phase IIb study is an international, multicenter, open label, randomized, controlled clinical trial to evaluate the safety and efficacy of treatment with CoFactor plus 5-fluorouracil (5-FU) in patients with metastatic colorectal carcinoma.
Adventrx plans to conduct the trial in the UK, Germany, Romania, Poland, Serbia, India and Croatia with approximately 300 patients and expects to begin patient enrollment by the end of April 2005.
“This clearance comes on the heels of meeting our primary clinical endpoint for response rate with our ongoing US CoFactor phase II trial in metastatic colorectal cancer,” said Evan Levine, president and CEO of Adventrx. “This is an important step in the overall late stage clinical development of CoFactor and we look forward to launching this phase IIb trial in the UK and other countries involved.”
Adventrx has filed for clearance to initiate a phase III trial in the US with CoFactor in metastatic colorectal cancer and currently plans to file in the first half of this year for clearance to initiate an EU-based phase III study in pancreatic cancer.