Study oversight
Anderson cancer, Anderson Cancer, toxicities
The study was conducted in compliance with the Declaration of Helsinki, Good Clinical Practice, and all relevant federal, state and local regulatory guidelines and was approved by the MD Anderson cancer center Institutional Review Board (IRB). To ensure adherence to the study procedures and patient safety, the study was monitored by Investigational New Drug (IND) office at MD Anderson Cancer Center. All treatment-related toxicities experienced by the patients, including any cases of early termination, were reported to and reviewed by the IND office before approval of enrollment to subsequent cohorts.