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
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
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03414489
First Posted
January 22, 2018
Last Updated
March 14, 2022
Sponsor
RedHill Biopharma Limited
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
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Primary Completion Date
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Study Completion Date
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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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