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.Supratek Pharma has reported that under the special protocol assessment process, it has obtained agreement with the FDA for the design of its pivotal study protocol for SP1049C, for the treatment of metastatic adenocarcinoma of the upper gastrointestinal tract.
Subscribe to our email newsletter
The randomized, multicenter Phase III pivotal clinical trial will compare SP1049C plus best supportive care (BSC) versus BSC alone for the treatment of patients with advanced adenocarcinoma of the esophagus, gastroesophageal junction and stomach who have failed adjuvant or first- or second-line chemotherapy. Supratek Pharma is the sponsor of the international trial and its clinical oncology team will direct the clinical development program.
Christopher Newman, vice president and chief medical officer of Supratek Pharma, said: “In the SPA communication, the FDA advised that the clinical design and analysis plan of our submitted protocol are suitable to provide evidence of safety and efficacy to support a new drug application for SP1049C for the treatment of cancer of the upper gastrointestinal tract.”