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.”