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

  1. #1
    Super Moderator Top User ddessert's Avatar
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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
    @pancanology

  2. #2
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    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
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    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
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    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
    - Ca-19 up to over 6,000
    April '19 - Started 5-fu, Abraxane, Oxaliplatin
    Ca-19 down to 600, missing many doses due to
    low platelets
    Aug '19 - Started Irrinotecan, abraxane, cysplatin
    missing doses, low platelets
    Sept '19 - Ca-19 holding steady, ct scan shows 2 small
    lung nodules - 3mm, 5mm, blood clot in pulmonary
    vein, primary and liver mets stable started blood thinner
    Oct. '19 Switched back to POLF treatment - Paclitaxel,Oxaliplatin,
    Leucovorin, 5FU

  5. #5
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    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.

  6. #6
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    JUST HEARD that a hospital in Athens GA is starting the phase III in December. AND Vanderbuilt in Nashville is doing the study...

    DANG WE NEED SOME WEST COAST Hospitals to pick it up.

    ABOUT ME. Monday September 30, 2019 will be my FOURTH YEAR ANNIVERSARY!!!!!!!

    This diagnosis is not normally something to celebrate. But Im very much alive. And continue to be very active, especially for a 71 year old PC patient... My wife and I decided to skip Burning Man this year. HOPE to go back next year.
    We just got back from a week in Watkins Glen NY with the grandkids. That's 600 miles EACH WAY!!!!! we broke the trip into two days each way. But driving a 20 ft class b camper towing a 24 ft camper is a challenge. ESPECIALLY labor day weekend.

    BTW, Tuesday Oct 1, I get ROUND 93 of this chemo. An old man will do anything to hang around a group of SUPER NICE NURSES...

    I CONTINUE TO BE AN UNPAID Internet Ambassador for CPI613.

    I continue to be in touch with David Wingo, Patient #5 in the phase 1 study. He is in his 64th Month...… THAT OVER 5 YEARS!!!! only about 1% of all PC patients live 5 years. AND that includes the stage 1 patients that have Positive results of the whipple.

    CPI613 Rocks!!!!

    for more info email me at [email protected] That email thinks im on vacation and will auto reply with a WEALTH of Info on CPI613, Me and David Wingo and Rafael Pharmaceuticals . If you have specific questions I will try to help also. So Email me.





    Quote Originally Posted by cobraearl View Post
    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.

  7. #7
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    Hi all,
    I just heard there was going to be phase III clinical trial here in France, named Avenger 500.
    It’s great news.
    Yet it seems to be randomized trials. Is it true ? So I just wonder : if the results in the group effectively being administered CPI 613 appear to be really better than in the other, could the trial « switch » every patients to it ?
    I remember that has been the case for some drugs in clinical trials that had excellent results ?
    Thanks for your answers (and sorry for my poor English)

  8. #8
    Quote Originally Posted by cobraearl View Post
    J

    I continue to be in touch with David Wingo, Patient #5 in the phase 1 study. He is in his 64th Month...… THAT OVER 5 YEARS!!!! only about 1% of all PC patients live 5 years. AND that includes the stage 1 patients that have Positive results of the whipple.

    CPI613 Rocks!!!!

    for more info email me at [email protected] That email thinks im on vacation and will auto reply with a WEALTH of Info on CPI613, Me and David Wingo and Rafael Pharmaceuticals . If you have specific questions I will try to help also. So Email me.
    Thanks much for the information. I will be emailing you later this evening.

    RW

  9. #9
    Cobraearl, I've been very hopeful about this drug. I also try to stay hopeful in general, and I'm afraid the stats you give could take away hope. It's still dismal, but the survival rate for PC is not as low as 1% over five years. Thanks for good news.
    February 2016- diagnosed with PC
    March 2016- inoperable due to arteries, also liver mets suspected
    March 2016-January 2017 -Gemzar/Abraxane
    February 2017 surgery-PC tumour and liver mets removed at same time
    July 2018 Back on Gemzar/Abraxane due to rising CA 19-9. Scans were clear.
    January 2019 Tried FOLFIRINOX after G/A became ineffective. FFX doesn't work. CA 19-9 rising
    February 2019 two small tumors appear on liver
    May 2019 - CA 19-9 skyrocketing. Started IMRT radiation treatment.
    August 2019 MRI done. No Evidence of Disease (NED). CA 19-9 dropped significantly. Still not normal range.

  10. #10
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    I'm also hopefull about this treatment. Something that gives me pause though, is the combination with folfirinox. This chemo itself is usually not effective over years and years (let alone being more difficult to take). I understand that Cobra Earl is taking a reduced dose. Is there some thing novel in the cpi613 that helps folfirinox work for longer periods of time? And the reduced dose plus the cpi613 results in better tolerability?
    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
    - Ca-19 up to over 6,000
    April '19 - Started 5-fu, Abraxane, Oxaliplatin
    Ca-19 down to 600, missing many doses due to
    low platelets
    Aug '19 - Started Irrinotecan, abraxane, cysplatin
    missing doses, low platelets
    Sept '19 - Ca-19 holding steady, ct scan shows 2 small
    lung nodules - 3mm, 5mm, blood clot in pulmonary
    vein, primary and liver mets stable started blood thinner
    Oct. '19 Switched back to POLF treatment - Paclitaxel,Oxaliplatin,
    Leucovorin, 5FU

 

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