Posted On: 05/21/2013 8:17:01 PM
Post# of 72443
Just got a response today to an email I sent to Leo after the abstract was posted. (guess the fact that i got a response also answers the speculation about a quiet period)
my question:
With the ASCO abstract now published, I had a question that you can hopefully answer or at least give me some insight on.
The ASCO abstract stated the following:
The starting dose was 10 mg/m2
What does this equate to in just plain total mg administered for the first cohort patients? Just trying to make sense of the dosing and escalation plan. I understand these cohorts take time to stage and get underway, so I am just trying to wrap my head around what is a reasonable range of the number of cohorts to expect in the trial? General consensus among us shareholders is there should be 5-6 cohorts before MTD is reached, but of course we are all guessing and that is obviously what the trial is for. Thanks for any insight you are able to provide.
The response:
Body surface area is calculated by the formula:
http://upload.wikimedia.org/math/5/4/7/5474a2...058178.png
Average men may be about 1.73 m^2 and women 1.71 m^2, or they receive about 17.3mg OR 17.1 mg respectively. It is calculated individually before administration.
We have no way of being certain but expect MTD could be reached in 5 to 9 cohorts. (If this werent a cancer study with stage 4 patients, one would estimate about 5 cohorts to reach MTD.)
Hopefully that clears up some of the confusion regarding what the starting dose was. Can anyone figure what the doses for the later cohorts would be?? (Calling Seel and polkadot!)
my question:
With the ASCO abstract now published, I had a question that you can hopefully answer or at least give me some insight on.
The ASCO abstract stated the following:
The starting dose was 10 mg/m2
What does this equate to in just plain total mg administered for the first cohort patients? Just trying to make sense of the dosing and escalation plan. I understand these cohorts take time to stage and get underway, so I am just trying to wrap my head around what is a reasonable range of the number of cohorts to expect in the trial? General consensus among us shareholders is there should be 5-6 cohorts before MTD is reached, but of course we are all guessing and that is obviously what the trial is for. Thanks for any insight you are able to provide.
The response:
Body surface area is calculated by the formula:
http://upload.wikimedia.org/math/5/4/7/5474a2...058178.png
Average men may be about 1.73 m^2 and women 1.71 m^2, or they receive about 17.3mg OR 17.1 mg respectively. It is calculated individually before administration.
We have no way of being certain but expect MTD could be reached in 5 to 9 cohorts. (If this werent a cancer study with stage 4 patients, one would estimate about 5 cohorts to reach MTD.)
Hopefully that clears up some of the confusion regarding what the starting dose was. Can anyone figure what the doses for the later cohorts would be?? (Calling Seel and polkadot!)
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