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  • gavin
    Moderator

    ABC-108: Study of ABC294640 (Yeliva®) in the Treatment of Patients With Advanced Cholangiocarcinoma

    ABC-108: Study of ABC294640 (Yeliva®) in the Treatment of Patients With Advanced Cholangiocarcinoma

    https://clinicaltrials.gov/ct2/show/NCT03377179

    Gavin

    gavin
    Moderator

    ABC-108: Study of ABC294640 (Yeliva®) in the Treatment of Patients With Advanced Cholangiocarcinoma

    ABC-108: Study of ABC294640 (Yeliva®) in the Treatment of Patients With Advanced Cholangiocarcinoma

    https://clinicaltrials.gov/ct2/show/NCT03377179

    Gavin

    #99437
    Litvak
    Participant

    Hi Fred,

    maybe the results regarding the effectiveness of YELIVA are in?

    – MB

     

    gavin
    Moderator

    ABC-108: Study of ABC294640 (Yeliva®) in the Treatment of Patients With Advanced Cholangiocarcinoma

    ABC-108: Study of ABC294640 (Yeliva®) in the Treatment of Patients With Advanced Cholangiocarcinoma

    https://clinicaltrials.gov/ct2/show/NCT03377179

    Gavin

    gavin
    Moderator

    ABC-108: Study of ABC294640 (Yeliva®) in the Treatment of Patients With Advanced Cholangiocarcinoma.

    https://cholangiocarcinoma.org/abc-108/

    https://clinicaltrials.gov/ct2/show/NCT03377179

    Gavin

    #98863
    bglass
    Moderator

    Hi Fred,

    Thank you for your note.  I looked through the discussion board and while there is discussion about possibly seeking this treatment, I did not find any patients who wrote about being treated with Yeliva.  I also contacted a caregiver who was looking into it, and that patient did not in the end pursue Yeliva either.  Hopefully, if a patient or caregiver who is under Yeliva treatment sees this string, they will post on their experience.

    If you do enroll in this trial, I hope you will keep us posted.

    Regards, Mary

     

    #98470

    In reply to: Yeliva

    gavin
    Moderator

    A google search throws this up for you W.

    https://www.google.com/search?q=yeliva+cholangiocarcinoma&rlz=1C1ASUM_enGB770GB770&oq=yeliva+cholangiocarcinoma&aqs=chrome..69i57j69i60l2.5791j0j7&sourceid=chrome&ie=UTF-8

    Gavin

    #98453

    In reply to: Yeliva

    gavin
    Moderator

    Hi W,

    Yes Yeliva has come up on the boards and been discussed before and I think a few of the members here have some experience of this. Hopefully they will chip in soon with their experiences of it. In the meantime, I did a search of the boards for you and come up with this –

    https://cholangiocarcinoma.org/db/search/yeliva/

    Hopefully you will be able to get more info from the links and discussions contained in the link above.

    My best to you,

    Gavin

    #98450

    Topic: Yeliva

    Whammoudeh
    Participant

    Hi everyone, we are exploring yeliva. Does anyone have experience or know anyone who has tried it? Some first hand accounts would really help us decide whether to continue to seek access.

    Best,

    W

    #97669

    In reply to: 3rd line treatment?

    Elodie
    Participant

    Hi lilitm,

    My name is Elodie and I’m Priscilla’s sister. I am really sad to hear about your dad 2nd scan. I understand your feelings… I have never heard about biliary pneumonia. It seems a weird term… My first langage is French so that’s maybe why. Did a doctor mention you this term or was it only on the report? Also, is it the AST and ALT who are high or only GGT?

    I looked also for Yeliva… maybe it is a good option.  Do you know what are the side effects?

    We are thinking about you and your dad.

     

    Élodie

    #97661

    In reply to: 3rd line treatment?

    lilitm
    Participant

    Dear all,

    Yesterday at the NIH we got my dad’s 2nd scan and there was peritoneal growth and dilated bile ducts. so they don’t think immunotherapy trial is working.

    I hope somehow we will have a delayed response – although the trial doctor was very pessimistic about pseudo-progression for biliary cancer. But they don’t have the data yet from this trial, so i don’t know how he could know that… we were only the 2nd biliary patient on the trial, so how far along could the timeline be? Maybe he means other immuno trials… but what if the ablation made a difference? or the combo of anti pd-l1 and anti ctla4? They seemed to really discourage the idea that we try more immuno.

    The labs showed elevated LFTs (all over 3 times normal upper limits) but low bilirubin. Perhaps related to the dilated bile ducts – which on the scan it says may be caused by hilar infiltration? Does this mean he has mets to the lung now?

    Nobody mentioned this but I read on the scan report that they saw biliary pneumonia?! I didn’t know that was possible, or what we are supposed to do about that.)

    So they said just wait and see how LFTs are next week – so we’re just supposed to hope it goes down on its own? They said with elevated LFTs, he can’t do this or other treatments anyway. I can’t tell if they were just beating around the bush because the dilated bile ducts and elevated LFTs without clear solvable cause are so dire? I have no idea how dire it really is.

    His constipation pains get so bad (even with constipation meds) and they mentioned that happens with peritoneal mets. So is there nothing to be done about it??

    But when he’s not having one of those pain episodes, he is strong enough to swim 30 laps almost every morning! I mean, of course he is fatigued and much weaker than before but it just seems impossible that there is nothing else we should try. Are they trying to tell us the end is near? I am so scared, and no idea what to do next.

    I was looking at the Yeliva expanded trial  because they had one complete response, but I’m scared of side effects and whether this will just  be harder on him. How do we  give him the best quality of life possible for as long as possible? I don’t even understand how palliative care could help with his constipation/digestion pains if it’s stemming from peritoneal mets… just mask the pain and knock him out with painkillers?!?

    I have no idea how terribly to take this news… more scared than ever.

    gavin
    Moderator

    RedHill Biopharma Announces Advancement to Second Stage of Phase IIa Study with YELIVA® for Cholangiocarcinoma

    The first stage of the Phase IIa study with YELIVA® for advanced cholangiocarcinoma (bile duct cancer), a highly lethal malignancy, achieved its pre-specified efficacy goal, and the study can therefore continue to its second stage, enrolling the full cohort of 39 evaluable patients who previous received other treatments

    Complete response (i.e. disappearance of all target lesions and all non-target lesions) reported in U.S. patient with advanced gallbladder carcinoma treated with YELIVA® as part of RedHill’s Expanded Access Program, allowing compassionate use for eligible patients

    https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=1384&PID=0&IID=9184

     

    lilitm
    Participant

    Does anyone have any experience with Yeliva? Is it a good idea if an immunotherapy trial fails, or perhaps more promising and should be tried first? Is it similar to Avastin? Any benefits? Thanks so much

    gavin
    Moderator

    Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)

     

    Please note that information regarding clinical trials is being rovided for informational purposes only.The Cholangiocarcinoma Foundation does not endorse any specific clinical trial. Please discuss any questions you may have about clinical trials with your healthcare provider.

    https://clinicaltrials.gov/ct2/show/NCT03414489

    Study Description

    Go to
    Brief Summary:
    This is an expanded access program (EAP) for eligible participants who do not qualify for participation in, or who are otherwise unable to access, the ongoing clinical trial ABC-108. This program is designed to provide access to ABC294640 (Yeliva ®) for treatment of cholangiocarcinoma (CCA) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. An oncologist must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient’s medical history and program eligibility criteria.

    Condition or disease
    Intervention/treatment
    CholangiocarcinomaCholangiocarcinoma Non-resectableCholangiocarcinoma, PerihilarCholangiocarcinoma, ExtrahepaticCholangiocarcinoma, Intrahepatic
    Drug: ABC294640

     

    Study Design

    Go to
     

    Study Type  :
    Expanded Access
    Official Title:
    Expanded Access to ABC-108, A Phase IIA Study of ABC294640 in the Treatment of Patients With Advanced,Unresectable Intra-hepatic, Perihilar and Extra-Hepatic Cholangiocarcinoma
    Resource links provided by the National Library of Medicine

     

    Genetics Home Reference related topics: Cholangiocarcinoma
    Genetic and Rare Diseases Information Center resources: Bile Duct Cancer Klatskin Tumor
    U.S. FDA Resources

     

    Interventions

    Go to
    Eligibility Criteria

    Go to

     

    Information from the National Library of Medicine

    Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

     

    Ages Eligible for Study:
    18 Years and older   (Adult, Senior)
    Sexes Eligible for Study:
    All
    Criteria
    Inclusion Criteria:

    Diagnosis of cholangiocarcinoma
    Ineligible to participate in the ABC294640 clinical trial for the treatment of cholangiocarcinoma or geographically inaccessible to the trial.
    Judged by the treating oncologist to be medically suitable for treatment with ABC294640
    Willing and able to provide written, signed informed consent
    Approval by RedHill of the treating oncologist’s clinical trial experience for the purpose of making ABC294640 available
    Regulatory approval by the appropriate jurisdiction
    Exclusion Criteria:

    1. Any medical condition that may cause treatment with ABC294640 to be potentially harmful as judged by RedHill
    Contacts and Locations

    Go to

    Information from the National Library of Medicine

    To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

    Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414489

    Contacts

    Contact: Mark L Levitt, MD, PhD
    +972-3-541-3131
    mark@redhillbio.com

    Contact: Vered Katz Ben-Yair, MSc
    347-414-4462
    vered@redhillbio.com
    Sponsors and Collaborators
    RedHill Biopharma Limited
    More Information

    Go to

    Publications:Britten CD, Garrett-Mayer E, Chin SH, Shirai K, Ogretmen B, Bentz TA, Brisendine A, Anderton K, Cusack SL, Maines LW, Zhuang Y, Smith CD, Thomas MB. A Phase I Study of ABC294640, a First-in-Class Sphingosine Kinase-2 Inhibitor, in Patients with Advanced Solid Tumors. Clin Cancer Res. 2017 Aug 15;23(16):4642-4650. doi: 10.1158/1078-0432.CCR-16-2363. Epub 2017 Apr 18.
    Ding X, Chaiteerakij R, Moser CD, Shaleh H, Boakye J, Chen G, Ndzengue A, Li Y, Zhou Y, Huang S, Sinicrope FA, Zou X, Thomas MB, Smith CD, Roberts LR. Antitumor effect of the novel sphingosine kinase 2 inhibitor ABC294640 is enhanced by inhibition of autophagy and by sorafenib in human cholangiocarcinoma cells. Oncotarget. 2016 Apr 12;7(15):20080-92. doi: 10.18632/oncotarget.7914.
    Beljanski V, Knaak C, Smith CD. A novel sphingosine kinase inhibitor induces autophagy in tumor cells. J Pharmacol Exp Ther. 2010 May;333(2):454-64. doi: 10.1124/jpet.109.163337. Epub 2010 Feb 23.
    French KJ, Zhuang Y, Maines LW, Gao P, Wang W, Beljanski V, Upson JJ, Green CL, Keller SN, Smith CD. Pharmacology and antitumor activity of ABC294640, a selective inhibitor of sphingosine kinase-2. J Pharmacol Exp Ther. 2010 Apr;333(1):129-39. doi: 10.1124/jpet.109.163444. Epub 2010 Jan 8.

    Responsible Party:
    RedHill Biopharma Limited
    ClinicalTrials.gov Identifier:
    NCT03414489     History of Changes
    Other Study ID Numbers:
    ABC-108-EA

    First Posted:
    January 30, 2018    Key Record Dates
    Last Update Posted:
    January 30, 2018
    Last Verified:
    January 2018

    Keywords provided by RedHill Biopharma Limited:

    Clinical Trial, Phase II
    Multicenter Trials
    Clinical Study
    Clinical Trials, Non-Randomized
    Oral capsule
    Single arm
    Anti-cancer

    Anti-inflammatory
    ABC294640
    Expanded Access Program
    Compassionate Use
    Special Access Program
    Yeliva ®

     

    Additional relevant MeSH terms:

    Cholangiocarcinoma
    Klatskin Tumor
    Adenocarcinoma
    Carcinoma

    Neoplasms, Glandular and Epithelial
    Neoplasms by Histologic Type
    Neoplasms

     

     

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    gavin
    Moderator

    RedHill Biopharma Announces Initiation of Phase IIa Study with ABC294640 (YELIVA®) for Cholangiocarcinoma at Mayo Clinic and MD Anderson

    http://www.nasdaq.com/press-release/redhill-biopharma-announces-initiation-of-phase-iia-study-with-abc294640-yeliva-for-20171222-00194

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