Speaker: Steven H. Stein, M.D., Senior Vice President, US Clinical Development & Medical Affairs, Novartis Oncology US
SIGNATURE is a patient-triggered, target specific, tissue-agnostic clinical trial program. Each trial tests a drug that targets a specific genetic mutation. Patients with any tumor can enroll as long as they have the target mutation, and meet minimal inclusion criteria. Experienced Research Physicians with pre-identified patients (based on local mutational testing) contact the SIGNATURE Call Center to qualify their patient and trigger rapid study startup. The research site will be opened within 3 weeks. This allows the patient to remain close to their Physician as we deliver the "Protocol to the Patient". The endpoint of the study is Clinical Benefit Rate, and Safety. Using adaptive statistical design, data is analyzed frequently to look for early signals of efficacy, or to close enrollment in tumor types that do not show efficacy. Using this new approach, we can test an individual drug in multiple tumors, versus the old model of conducting individual studies for each tumor.