perifosine trial open?

jscho
jscho Member Posts: 62
edited March 2014 in Colorectal Cancer #1
For those of you looking into clinical trials, the phase III perifosine trial looks like it is finally open. This drug showed a lot of promise in the phase II trials, and is worth looking at:

http://clinicaltrials.gov/ct2/show/NCT01097018?term=perifosine&rank=37

The drug should work for many different types of genotypes since it interferes not with a single enzymatic target (i.e a particular kinase) but by being incorporated into the cell membrane and disturbing cell signaling processes that occur near the membrane (PI3K-Akt, Raf-Mek-Erk).

Good health.
Jeremy

Comments

  • dianetavegia
    dianetavegia Member Posts: 1,942 Member
    No exposure to Xeloda
    Looks like the only problem is if someone was allergic to 5FU or took Xeloda.

    Recruiting right now in Georgia. Maybe Patti will see this!

    CLICK HERE It's a blind study so some people will receive a placebo. :-(
  • lisa42
    lisa42 Member Posts: 3,625 Member
    checked it out
    Thanks for the info, Jeremy.
    I did check out and read all the info on the link. This particular study is taking place in Florida, Georgia, and Tennessee. It compares taking perifosine pills and capecitabine pills (Xeloda) vs. taking just the Xeloda and a placebo. I don't know if there's any choice there or not if you can know you're getting the perifosine pills or not. That does scare me, as I've failed on just Xeloda alone before. Then I read further down and among the inclusion criteria for the study, it said no previous exposure to capecitabine except for in a radioclinical setting (I'm thinking maybe that means taking it while getting radiation, but am not totally sure). So, I guess that would exclude anyone who has already taken Xeloda, as I have. Too bad, I was getting excited that another opportunity may be opening up for me. I'm sure it will be an opportunity for some people, however, so thanks for posting it.

    Lisa
  • coloCan
    coloCan Member Posts: 1,944 Member
    lisa42 said:

    checked it out
    Thanks for the info, Jeremy.
    I did check out and read all the info on the link. This particular study is taking place in Florida, Georgia, and Tennessee. It compares taking perifosine pills and capecitabine pills (Xeloda) vs. taking just the Xeloda and a placebo. I don't know if there's any choice there or not if you can know you're getting the perifosine pills or not. That does scare me, as I've failed on just Xeloda alone before. Then I read further down and among the inclusion criteria for the study, it said no previous exposure to capecitabine except for in a radioclinical setting (I'm thinking maybe that means taking it while getting radiation, but am not totally sure). So, I guess that would exclude anyone who has already taken Xeloda, as I have. Too bad, I was getting excited that another opportunity may be opening up for me. I'm sure it will be an opportunity for some people, however, so thanks for posting it.

    Lisa

    Just read that FDA is fast-tracking use of perifosine,
    or KRX-0401,for CCR treatment, with a phase 3 trial set to begin by end of 2011,"followed by a US launch for perifodsine in 2012."......reuters.com

    steve

    Fast track also "grants the drug developers seven years of market exclusivity."
  • jscho
    jscho Member Posts: 62
    coloCan said:

    Just read that FDA is fast-tracking use of perifosine,
    or KRX-0401,for CCR treatment, with a phase 3 trial set to begin by end of 2011,"followed by a US launch for perifodsine in 2012."......reuters.com

    steve

    Fast track also "grants the drug developers seven years of market exclusivity."

    This is a trial of KRX-0401
    I'm a little confused here. This is a phase III trial that is scheduled to end in September 2011. It is NOW open and in the United States.

    Jeremy
  • coloCan
    coloCan Member Posts: 1,944 Member
    jscho said:

    This is a trial of KRX-0401
    I'm a little confused here. This is a phase III trial that is scheduled to end in September 2011. It is NOW open and in the United States.

    Jeremy

    A fine example of chemo brain at work- I miswrote!!!!!
    You're right,Jeremy,I apologize for confusion; should have stated "study completion expected in second half of 2011." Commercialization expected to start mid-2012 if results indicate success.

    Its "an oral anti-cancer agent that inhibits Akt activationb in the phosphoinositide 3-kinase (P13K) pathway, for the treatment of refractory advanced colkorectal cancer."

    Made by Keryx biopharmaceuticals in the US with Canada's Aeterna Zentaris;;;;steve

    Sorry for misinfo in first post--embarrassing!!!!