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I made some posts about this on the other board.

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Post# of 72447
Posted On: 02/01/2013 10:38:30 PM
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Posted By: TOB

I made some posts about this on the other board.


The data referenced in the PR would not involve shrinking tumours and gene activation, It is the PK data which is how the drug is absorbed, distributed, metabolized and eliminated by the body, not scans which would indicate tumour shrinkage.


They also won't be presenting any data at ASCO unless it has already been publicly presented or published.


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http://chicago2013.asco.org/trials-progress


What is acceptable in a Trials in Progress abstract and poster?



  • Scientific background/rationale for the trial. Preclinical and/or earlier-phase clinical data that has already been publically presented or published may be included with references. The Trials in Progress session should not be used to present preclinical or earlier-phase clinical data for the first time.



  • Trial design and statistical methods, highlighting any novel aspects of the design



  • Treatment or intervention planned



  • Major eligibility criteria, highlighting unusual aspects



  • Correlative studies of particular interest



  • Current enrollment without providing results or endpoints



  • Enrollment must have already begun or have been completed with no data analysis available.


Phase I studies may say, “Cohorts 1 and 2 have been completed without DLT . Enrollment to cohort 3 began in January 2011.”


What is not acceptable in a Trials in Progress abstract?



  • Any preliminary data including toxicity, response rate, PK , or correlative analyses. NOTE : Abstracts including results or preliminary data will be rejected without further review.





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