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Clinical Trial Details — Status: Available

Administrative data

NCT number NCT03414489
Other study ID # ABC-108-EA
Secondary ID
Status Available
Phase
First received
Last updated

Study information

Verified date March 2022
Source RedHill Biopharma Limited
Contact Mark L Levitt, MD, PhD
Phone +972-3-541-3131
Email mark@redhillbio.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.


Recruitment information / eligibility

Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
ABC294640


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
RedHill Biopharma Limited

References & Publications (4)

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. — View 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 S — View 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. — View 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. — View Citation

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