ClinicalTrials.gg
No longer availableNCT03414489Updated Mar 18, 2025

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

An expanded access record providing ABC294640 in Cholangiocarcinoma, Cholangiocarcinoma Non-resectable and Cholangiocarcinoma, Perihilar, sponsored by RedHill Biopharma Limited. No longer available. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-18.

Primary conditionKlatskin TumorRegistry: CholangiocarcinomaReclassifiedWhy we changed it
Registry
Cholangiocarcinoma — the first condition term the registry derived for this study.
ClinicalTrials.gg
Klatskin Tumor
Why
  1. The study's listed conditions name Klatskin Tumor, a narrower term within Cholangiocarcinoma.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by RedHill Biopharma Limited · Expanded access

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Study type
Expanded access
Access type
Individual patients
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cholangiocarcinoma
  • Cholangiocarcinoma Non-resectable
  • Cholangiocarcinoma, Perihilar
  • Cholangiocarcinoma, Extrahepatic
  • Cholangiocarcinoma, Intrahepatic

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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
03

In context

Klatskin Tumor Reclassified

82 studies on the registry are indexed under Klatskin Tumor; 27 are open to participants now.

Browse Klatskin Tumor studies →

Lead sponsor

RedHill Biopharma Limited is the lead sponsor of 19 studies on the registry; 2 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Compared within Klatskin Tumor, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cholangiocarcinoma. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  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

Exclusion Criteria:

  1. Any medical condition that may cause treatment with ABC294640 to be potentially harmful as judged by RedHill
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

06

Where to request access

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 26956050 ↗
  • 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. PubMed 20179157 ↗
  • 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. PubMed 20061445 ↗
  • 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. PubMed 28420720 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03414489
Lead sponsor
RedHill Biopharma Limited
Responsible party
Sponsor
First posted
Jan 30, 2018
Last update
Mar 18, 2025
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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