Cholangiocarcinoma Clinical Trial
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
NCT number | NCT03414489 |
Other study ID # | ABC-108-EA |
Secondary ID | |
Status | Available |
Phase | |
First received | |
Last updated |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
RedHill Biopharma Limited |
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
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05497531 -
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
|
N/A | |
Recruiting |
NCT05678218 -
Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
|
||
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT05179486 -
Molecular Epidemiology of Biliary Tree Cancers
|
||
Suspended |
NCT05124743 -
HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
|
||
Terminated |
NCT04304781 -
Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer
|
Phase 1 | |
Completed |
NCT03150615 -
Enteral Nutrition After Pancreaticoduodenectomy
|
N/A | |
Completed |
NCT01912053 -
Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma
|
Phase 2 | |
Recruiting |
NCT01439698 -
Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry
|
N/A | |
Terminated |
NCT01434459 -
Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin
|
Phase 1 | |
Completed |
NCT01206049 -
Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations
|
Phase 2 | |
Recruiting |
NCT00973713 -
Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol
|
Phase 2 | |
Terminated |
NCT00975039 -
Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma
|
Phase 2 | |
Completed |
NCT00779454 -
Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma
|
Phase 2 | |
Terminated |
NCT04066491 -
Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
|
Phase 2/Phase 3 | |
Recruiting |
NCT04340986 -
Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma
|
||
Active, not recruiting |
NCT04526106 -
REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03603834 -
Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma
|
Phase 2 | |
Recruiting |
NCT05007106 -
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
|
Phase 2 |