Something I don't understand. If the trial design is "finalized", how can things like trial location and number of required patients not yet be determined?
Major factors in the overall trial design are:
The clinical trial will be international (United States, Europe and possibly Australia), multi-site, open-label and randomized.
Study sites under consideration in the United States include the Mayo Clinic in Scottsdale, Arizona, the Beth Israel Deaconess Cancer Center and the Dana-Farber Cancer Institute both in Boston, Massachusetts, the Baylor Cancer Center in Dallas, Texas, the City of Hope Cancer Center in Los Angeles, California, and sites in Germany and Spain.
As many as 84 patients will be required to complete the study, although fewer may be required based upon the data developed during the trial.
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