Date: 2016-10-21
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Boston Biomedical (USA - MA)
Product: napabucasin (BBI608)
Action
mechanism: cancer cell stemness inhibitor. Napabucasin is an orally-administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3. Napabucasin is currently being investigated in three Phase III studies in advanced gastric and GEJ , colorectal ) and lung cancer. It is also being investigated in earlier phases in multiple solid and hematologic malignancies, including tumors of the liver, pancreas and brain.
Disease: colorectal cancer
Therapeutic area: Cancer - Oncology
Country: Japan, USA
Trial
details: This is an international multi-center, prospective, open-label, randomized phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC). (NCT02753127)
Latest
news: * On October 21, 2016, Boston Biomedical announced dosing of the first patient in CanStem303C, a new global Phase III study investigating napabucasin in combination with standard of care (FOLFIRI) in patients with previously treated metastatic colorectal carcinoma (mCRC). Patients in this global Phase III study will be randomized in a 1:1 ratio to receive either two daily doses of 240 mg napabucasin – an orally administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3 – plus biweekly FOLFIRI or biweekly FOLFIRI alone. The study also allows for the addition of bevacizumab per direction by the study investigator. A total of 1,250 patients will be enrolled in the study. The primary endpoint of the study is overall survival. Secondary endpoints include progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), safety and quality of life. Overall survival, PFS, ORR and DCR analyses will be conducted in the general study population as well as in biomarker-positive patients.
