Clinical trial ABBV-399

Discussion Board › Forums › Clinical Trials › Clinical trial ABBV-399

Viewing 4 posts - 1 through 4 (of 4 total)
  • Author
    Posts
  • November 13, 2016 at 8:27 pm #24756
    marions
    Moderator

    Michelle…..fingers crossed for a fantastic and full response to current treatment.
    Hugs
    Marion

    November 13, 2016 at 2:23 am #24755
    mvpratt
    Spectator

    Sorry I have been away a bit but I have been super busy with the start of the trial. I am almost finished the first cycle.

    I believe I am in Cohort F as I am on a dose escalating 28 day cycle. I am at the low dose end however I was just told that I am in Process 2.

    I just finished my second treatment. I am receiving my treatment at Duke Hospital with Dr. Strickler. He has a ton of active studies that he is willing to try and qualify cholangiocarcinoma patients. I have also learned that he has several other C MET studies that have involved HER + breast cancers.

    I am doing well. Just noticed fatigue today and some joint aches. I scan in December so we will see how I do.

    Hope all is well.
    Michelle

    PS if anyone is on a CMET therapy I would love to hear from you.

    October 29, 2016 at 3:31 am #24754
    marions
    Moderator

    Michelle….thanks for sharing and wishing you the best of luck. Michelle, do you know which cohort study you are enrolled in?

    Experimental: Cohort A (ABBV-399)
    ABBV-399 will be administered at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate ABBV-399.

    Experimental: Cohort C (ABBV-399 plus Cetuximab)
    ABBV-399 to be evaluated with Cetuximab.

    Experimental: Cohort D (ABBV-399 plus Bevacizumab)
    ABBV-399 to be evaluated with Bevacizumab.

    Experimental: Cohort F (ABBV-399)
    ABBV-399 will be administered at escalating dose levels in 28-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate ABBV-399.

    Experimental: Cohort E (ABBV-399 plus Nivolumab)
    ABBV-399 to be evaluated with Nivolumab.

    This is the link to the study protocol:
    https://clinicaltrials.gov/ct2/show/NCT02099058

    Contact: Juliette Beaulieu, MS 650-454-2753 juliette.beaulieu@abbvie.com
    Contact: Judy Li, BS 650-454-2840 judy.li@abbvie.com

    Locations:

    United States, Arizona
    Site Reference ID/Investigator# 123761 Recruiting
    Scottsdale, Arizona, United States, 85258
    Principal Investigator: Site Reference ID/Investigator# 123761, MD

    United States, California
    Site Reference ID/Investigator# 148295 Recruiting
    Los Angeles, California, United States, 90095
    Principal Investigator: Site Reference ID/Investigator# 148295, MD
    Site Reference ID/Investigator# 129805 Recruiting

    Sacramento, California, United States, 95817
    Principal Investigator: Site Reference ID/Investigator# 129805, MD
    United States, Colorado
    Site Reference ID/Investigator# 123759 Recruiting

    Aurora, Colorado, United States, 80045
    Principal Investigator: Site Reference ID/Investigator# 123759, MD
    United States, Illinois
    Site Reference ID/Investigator# 136995 Recruiting

    Chicago, Illinois, United States, 60637
    Principal Investigator: Site Reference ID/Investigator# 136995, MD
    United States, Massachusetts
    Site Reference ID/Investigator# 129804 Recruiting

    Boston, Massachusetts, United States, 02114
    Principal Investigator: Site Reference ID/Investigator# 129804, MD
    Site Reference ID/Investigator# 135314 Recruiting

    Boston, Massachusetts, United States, 02114
    Principal Investigator: Site Reference ID/Investigator# 135314, MD
    United States, Michigan
    Site Reference ID/Investigator# 149857 Recruiting

    Detroit, Michigan, United States, 48202
    Principal Investigator: Site Reference ID/Investigator# 149857, MD
    United States, Missouri
    Site Reference ID/Investigator# 143798 Recruiting
    St. Louis, Missouri, United States, 63110
    Principal Investigator: Site Reference ID/Investigator# 143798, MD

    United States, North Carolina
    Site Reference ID/Investigator# 123763 Recruiting
    Durham, North Carolina, United States, 27710
    Principal Investigator: Site Reference ID/Investigator# 123763, MD

    United States, Tennessee
    Site Reference ID/Investigator# 129802 Recruiting
    Nashville, Tennessee, United States, 37203
    Principal Investigator: Site Reference ID/Investigator# 129802, MD
    United States, Texas

    Site Reference ID/Investigator# 123760 Recruiting
    Dallas, Texas, United States, 75230
    Principal Investigator: Site Reference ID/Investigator# 123760, MD
    Site Reference ID/Investigator# 154528 Not yet recruiting
    Dallas, Texas, United States, 75390-8852
    Principal Investigator: Site Reference ID/Investigator# 154528, MD

    France
    Site Reference ID/Investigator# 132747 Recruiting
    Villejuif, Cedex, France, 94805
    Principal Investigator: Site Reference ID/Investigator# 132747, MD

    Hugs
    Marion

    October 28, 2016 at 9:49 pm #1778
    mvpratt
    Spectator

    Hi All!

    I have just started a clinical trial that targets the CMet mutation. I am curious if there is anyone else out there on this trial or has tried this trial. I am the first person at Duke on the improved version of ABBV-399. The formal name of the study is :

    Phase 1/1b, Open label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in subjects with Advanced Solid Tumors.

    I would love to hear if anyone has participated in this study or has knowledge of anything about this study.

    It looks very promising as the drug targets the CMet mutation which is only found in malignancies.

    I had my first infusion on the 27th. Drug ran over 30 minutes and then a quick flush. Because it was my very first treatment I had to stay for an additional 3 hours for vitals and labs. I had to return today for timed lab work. I go back on Monday to see the doctor and more labs.

    It has been a great experience. I definitely feel well cared for as the research RN has been following me everywhere and handling anything that I might need. As an added bonus I get a meal ticket, parking pass, and mileage b/c I have to travel greater than 50 miles.

    I have learned that I am in the lesser end of the total amount of drug that is administered. There will be a second cohort if this dose is tolerated to get the top end amount of what is safe to be administered. Side effects so far have been pretty mild when I compare this drug to my gem/cis regimen…. neuropathy, n/v, fatigue, swelling of hands or feet, neutrapenia, thrombocytopenia, and elevated liver function studies.

    It is composed of ABT-700 and MMAE.

    And so far that is all I have to tell. Will keep everyone posted as I go further along in the study.

    Have a great weekend!!

    Michelle Pratt

    I will keep everyone

  • Author
    Posts
Viewing 4 posts - 1 through 4 (of 4 total)
  • The forum ‘Clinical Trials’ is closed to new topics and replies.