In general, no positive scan is required to move forward cohorts, just no evidence of harm and lack of toxicity. This was email to team member of Kevetrin asking about cohort movement. Not very general. The DF clinician on the drug development team was answering a question about forward movement of Kevetrin cohort one. Or was he?


A participant can advance to the next cycle assuming they tolerate the drug and perceive a benefit (stable disease or improvement) if scans are performed.




Sent: Thursday, January 10, 2013 10:43 AM
To: Wolanski, Andrew P.,N.P.
Subject: its me again



dear andrew,



in a previous email i asked what was needed for a participant to advance to the next cycle. i see some criteria on the nci trial page. you once told me that a participant had to RETRIEVE (emphasis mine) a benefit. does the word retrieve have any added significance? does the participant go on to the next cycle if they maintain the required blood counts and don't have serious vomiting and diarhea? or do they have to show that something positive has happened in regards to tumor growth even if it only means slowing down?

or something else?

ps now we have THE ANSWER. stable desease or improvement

mri scans are performed at 2 months. cohort 1 is in cycle 3.