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govorchin

12/14/12 11:11 AM

#14242 RE: TheDane #14238

Yes – everyone in the first cohort needs to complete a full cycle before a subsequent cohort opens. The escalation of the dose in subsequent cohorts is dependent on the how the prior dose levels fare. There are very specific rules to guide increases in the protocol document.



Patients enrolled in a specific dose level cannot have their dose increased, until the participants in a subsequent cohort have deemed it safe. For example, when dose level 3 opens, dose level two has been deemed tolerable and those receiving treatment in dose level one are allowed in this protocol to increase.



Hope that answers your questions

Andrew