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Thread: CPI-613 + mFOLFIRINOX: A real advance?

  1. #1
    Super Moderator Top User ddessert's Avatar
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    Oct 2013
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    CPI-613 + mFOLFIRINOX: A real advance?

    The phase 3 clinical trial for mFOLFIRINOX +/- CPI-613 (called AVENGER 500, NCT03504423) opened for enrollment in Chicago, IL and Winston-Salem, NC. With an expected enrollment of 500, I'd guess that it would have to open up quickly at other sites as well (ask PanCan.org for updated info). CPI-613 has recently been renamed devimistat.

    The phase 1 results NCT01835041 were impressive, although only results from 18 patients, according to the published paper (and study participant cobraearl from this forum). CPI-613 has already been used in a variety of cancers and over 300 patients.

    It appears that Rafael Pharmaceuticals confident enough that it is skipping the phase 2 trial (NCT03374852, 45 patients & never accrued) and going straight on to phase 3.

    I think this one may have some legs!
    BRCA2 3398del5
    Dec 2010 - back/abd pain
    May 2011 - Unresectable stage III, 2.5cm tumor
    Jun-Aug 2011 - Gem/Cis, 9 rounds
    Oct-Nov 2011 - IMRT+Xeloda
    Oct 2011-Sep 2012 - shrinking tumor
    Feb 2012 - National Familial Pancreatic Study
    Aug 2012 - Downgraded to stage IIA, PGP
    Sep 2012 - Whipple, T3N0M0, 0.5cm tumor, 0/16 lymph nodes
    Dec 2012 - Quebec PanCan Study
    Sep 2012-May 2019 - NED
    Mar 2013-present - NCT01088789
    Jun 2019- NCT03805919

  2. #2
    Regular User
    Join Date
    Feb 2017
    April 24, 2019, Direct from Rafael Phamacuticals the sites of the Phase III CPI613 study are:

    •NYU Langone Health - Paul Oberstein in NYC
    •Atlantic Health System - Angela Alistar in Morristown, NJ
    •Blue Ridge Cancer Care - Mark Kochenderfer in Roanoke, VA
    •Ingall Cancer Center (Chicago) - Mark Kozloff in Chicago, IL
    •Levine Cancer - Mohamed Salem in Charlotte, NC
    •Wake Forest - Caio Max, Rocha Lima in Winston Salem, NC
    •Huntsman Cancer Center (University of Utah) - Ignacio Garrido-Laguna in Salt Lake City, UT
    •University of Pittsburgh - Nathan Bahary in Pittsburgh, PA
    •University Hospitals Seidman Cancer Center (Cleveland) - David Bajor in Cleveland, OH

    More sites will be added as they are looking for up to 100 sites and up to 500 patients WORLD WIDE...

    To the best of my knowledge, To be part of the study, a patient has to have stage 4 pancreatic Cancer. AND must not have had any chemo yet.. there are other restrictions but these are two big restrictions.

  3. #3
    Regular User
    Join Date
    Feb 2017
    IM POSITIVE that CPI613 HAS LEGS...……. otherwise David Wingo and I would be Dead for several years!!!!!!!!! David was given 2 weeks to 2 months by his firs oncologist. In June 2019 he will be a FIVE YEAR SURVIVOR..

    In September 2019 I will be a FOUR YEAR survivor...….

    I know 4 more patients that survived about 3 years. Out of 18 patients...

  4. #4
    Senior User
    Join Date
    Mar 2018
    So have you guys been taking folfirinox along with cpi-613? Has that caused problems over that length of time of are you just cpi613 alone? I'm on this treatment and am curious.
    Mar. '18 - Diagnosed Stage IV with liver mets CA-19 124,000
    Apr. '18 - Started chemo - Gem, Abrx, Cis
    July and Sept '18 - Ct scan - all tumors shrinking
    Oct. '18 - CA-19 - 1,495
    Oct. '18 - Started Gem, Abrx 1/2 dose

  5. #5
    Regular User
    Join Date
    Feb 2017
    WE have both been taking Folfirinox plus CPI613..... Some one told me that we only get about 80% as much folfirinox as patients not getting the CPI613. I personally just completed chemo round 84. Wish I could quit but its impossible to know if im cured or not... only takes one bad cancer cell for it to come back. Im very willing to continue the chemo treatment.. as I only feel poorly about about 2 days of the 14 day cycle. AND ITS KEEPING ME ALIVE.

    I think David has had somewhere between 50 and 60 rounds... David works everyday as a building contractor except when he is hunting, fishing, playing with his grandkids or getting chemo. David is in his late 60's. Im 71.


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