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

Primary Purpose

Cholangiocarcinoma, Cholangiocarcinoma Non-resectable, Cholangiocarcinoma, Perihilar

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
ABC294640
Sponsored by
RedHill Biopharma Limited
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Cholangiocarcinoma focused on measuring 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 ®, opaganib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  1. Diagnosis of cholangiocarcinoma
  2. Ineligible to participate in the ABC294640 clinical trial for the treatment of cholangiocarcinoma or geographically inaccessible to the trial.
  3. Judged by the treating oncologist to be medically suitable for treatment with ABC294640
  4. Willing and able to provide written, signed informed consent
  5. Approval by RedHill of the treating oncologist's clinical trial experience for the purpose of making ABC294640 available
  6. 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 22, 2018
    Last Updated
    March 14, 2022
    Sponsor
    RedHill Biopharma Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03414489
    Brief Title
    Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)
    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
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    RedHill Biopharma Limited

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cholangiocarcinoma, Cholangiocarcinoma Non-resectable, Cholangiocarcinoma, Perihilar, Cholangiocarcinoma, Extrahepatic, Cholangiocarcinoma, Intrahepatic
    Keywords
    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 ®, opaganib

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ABC294640

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mark L Levitt, MD, PhD
    Phone
    +972-3-541-3131
    Email
    mark@redhillbio.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vered Katz Ben-Yair, MSc
    Phone
    347-414-4462
    Email
    vered@redhillbio.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26956050
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20179157
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20061445
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28420720
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

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

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