Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640

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

TO TOP