Personalized Therapy - Early Phase Clinical Trials

MSK experts strive to lead the way in every stage of the research process. All treatment options for cancer patients available today started with the early phase (phase I study) of a clinical trial.

Early phase trials of promising new medicines for solid tumors in the body of adult and pediatric cancer patients are conducted by MSK's Early Drug Development (EDD) Service. They run early phase clinical trials across disease types and molecular targets. Early Drug Development Service aims to

• Provide MSK patients the opportunity to access the latest drugs for specific cancer or cancer mutation at the earliest.
• Determine the optimal safe doses to start with later phases (phase II and phase III) and advance the research and development of new treatment modalities.
• Allow rapid evaluation of drugs showing promising results using advanced clinical trial designs like basket trials. This targets a specific genetic mutation in various tumors from different cancer types.

Early Phase Trials at MSK

• Experience - MSK, Memorial Sloan Kettering Cancer Center, was among the first institutions to receive the designation of a National Cancer Institute-designated Comprehensive Cancer Center in 1971. More than 600 clinical trials in different research phases for various types of cancer are currently ongoing at MSK. From these clinical trials, the EDD team is conducting around 35 early phase studies.
• Large Patient Groups - Early phase trials need a substantial number of volunteers. As MSK is a high-volume cancer center, patients with many disease types and rare cancers get enrolled in the trials. MSK's comprehensive care facilities at many regional sites have made the recruitment and study start-up more convenient and faster. For trials requiring more significant numbers of volunteers, MSK leads and participates in multisite trials and collaborates with other cancer centers.
• Experience - MSK-IMPACT™, MSK's targeted tumor-sequencing test, can match patients with tumors to targeted drugs based on the tumor's molecular profile. This US Food and Drug Administration authorized test provides the opportunity to choose the participants based on who will most likely be benefited from experimental therapies. It also detects microsatellite instability, which can identify people that may benefit from immunotherapy.
• Advanced Technologies - MSK-IMPACT™, MSK's targeted tumor-sequencing test, can match patients with tumors to targeted drugs based on the tumor's molecular profile. This US Food and Drug Administration authorized test provides the opportunity to choose the participants based on who will most likely be benefited from experimental therapies. It also detects microsatellite instability, which can identify people that may benefit from immunotherapy.
• Collaboration - A collaboration between MSK's physicians and scientists is the key to MSK's expansion of drug development initiatives. The EDD Service supports the Department of Medicine, Sloan Kettering Institute, and Human Oncology and Pathogenesis Program. MSK's EDD team also works closely with the Precision Pathology Biobanking Center, Marie-Josée and Henry R. Kravis Center for Molecular Oncology, Functional Genomics Initiative, Brain Tumor Center, and Center for Epigenetics Research.
• Study Support - MSK's experienced Primary Investigators oversee clinical trials at all their study sites. Their Primary Investigators collaborate with clinical research support teams, which includes research program managers, clinical research managers, clinical research supervisors, clinical trial nurses, and protocol research study assistants.
• Exceptional Patient Care - MSK experts provide comprehensive care to cancer patients, including their families, through all phases of treatment. Genetic counseling, pain management, rehabilitation, integrative medicine services, and assistance in managing life after treatment are included in cancer care. MSK's cancer care teams are in close communication with patients participating in clinical trials.