Study oversight
Hutchinson Cancer, Cancer
ONCOLOGY, CANCER
The protocol was approved by the institutional review board at each of the following sites enrolling patients: City of Hope, Duarte, CA; University of California Los Angeles, Los Angeles, CA; University of California, Irvine Medical Center, Orange, CA; University of California, Davis, Sacramento, CA; University of California, San Francisco, San Francisco, CA; Northwestern University Medical Center, Chicago, IL; Memorial Sloan Kettering Cancer Center, New York, NY; Tennessee Oncology, Nashville, TN; and Fred Hutchinson Cancer Research Center, Seattle, WA. The trial was conducted in accordance with the principles of the Declaration of Helsinki. An independent data and safety monitoring committee regularly reviewed safety data. All patients provided informed written consent. The trial protocol and statistical analysis plan were designed in a collaboration between the sponsor (PACT Pharma) and the authors.