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Re: RJFL post# 69184

Saturday, 09/13/2014 8:17:14 PM

Saturday, September 13, 2014 8:17:14 PM

Post# of 403092
Thumbs up from me too. There will be a great deal of information from the kevetrin trial. There's so much going on and it seems ihub has magnetized some really exceptional and knowledgeable people. WAY over my head as a mechanical engineering type so I find myself following along but I've been learning and continue to learn. From both sides. I agree with your statement that we're in the bottom of the 1st with phase 1 though soooo much has already been accomplished to get where we are. Even after phase 1 is completed there will be a time period to digest and publish all the data even as other trials start. One hell of a first inning imo.





Just posting this excerpt as a self reminder of the potential we're looking at.

http://www.clinicaltrials.gov/ct2/show/NCT01664000?term=Kevetrin&rank=1
Detailed Description:

Kevetrin was found to be effective in pre-clinical studies of human xenograft tumor models and was reasonably well-tolerated at therapeutic doses in the non-clinical animal studies. Kevetrin was also effective in multi-drug resistant tumor models; therefore, Kevetrin has the potential to treat tumors that have become resistant to standard chemotherapy. This trial will determine tolerance in humans and, possibly, efficacy with a Phase I, open-label, dose-escalation, safety, pharmacokinetic, and pharmacodynamic study of Kevetrin, in adult patients with solid tumors.

The primary objectives are the following:
•To determine the maximum tolerated dose (MTD) of Kevetrin.
•To determine the dose limiting toxicities (DLT) of Kevetrin.
•To establish a safe dose level of Kevetrin that can be used for future studies.

The secondary objectives are to determine the following:
•The pharmacokinetics of Kevetrin in humans.
•Observe for evidence of antitumor activity following administration of Kevetrin.
•If Kevetrin induces changes in the biomarker p21 in peripheral blood lymphocytes.
•If there is a pharmacodynamic relationship between the plasma concentrations of Kevetrin and a clinical or cellular effect.

Best to you (and everyone) as well from Virginia!

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