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NCT03377179 · ClinicalTrials.gov registry record · Phase 2
A Study of ABC294640 Alone and in Combination With HCQ Sulfate in the Treatment of Advanced Cholangiocarcinoma
A Phase 2 study of Cholangiocarcinoma and Cholangiocarcinoma, Intrahepatic, sponsored by RedHill Biopharma Limited.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 5
- Study locations
NCT03377179: Completed Phase 2 study of Cholangiocarcinoma and Cholangiocarcinoma, Intrahepatic, sponsored by RedHill Biopharma Limited.
NCT03377179 is a Phase 2 study of Cholangiocarcinoma and Cholangiocarcinoma, Intrahepatic that has completed, run by RedHill Biopharma Limited. The registered enrollment target is 65 participants, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (83% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03377179, a Phase 2 study of Cholangiocarcinoma and Cholangiocarcinoma, Intrahepatic, has completed, sponsored by RedHill Biopharma Limited.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 5
- Study locations
Study Summary
ABC-108 is a single-arm Phase IIA clinical study of ABC294640 (Yeliva ®, opaganib) alone and in combination with hydroxychloroquine sulfate (HCQ) in the treatment of cholangiocarcinoma (CCA). In Part 1 of this clinical study, all participants will be receiving ABC294640 and in Part 2 all participants will be receiving ABC294640 and HCQ to explore the drugs activity signal in CCA. The study drug, ABC294640 is an orally available inhibitor of the enzyme sphingosine kinase-2 (SK2). SK2 is an innovative target for anti-cancer therapy because of its critical role in sphingolipid metabolism, which is known to regulate tumor cell death and proliferation. ABC294640 also inhibits proliferation and induces apoptosis of cholangiocarcinoma cell lines. Furthermore, in a recent Phase I trial, ABC294640 demonstrated clinical activity in CCA patients. HCQ, is an orally available, FDA approved therapy for the treatment of malaria as well as discoid and systemic lupus erythematosus and rheumatoid arthritis. It is also known as an inhibitor of autophagy, a pro-survival mechanism utilized by many cancers. Evidence indicates that inhibition of autophagy can increase the therapeutic activity of ABC294640 in CCA. In Part 1 of this study, ABC294640 will be continuously administrated orally, twice a day, in 28 day cycles. In Part 2, ABC294640 and HCQ will be continuously administrated orally (the safe and tolerable will be determined in the study) in 28 day cycles. Administration of drug/s in both parts of the study will continue until disease progression, unacceptable toxicity or voluntary withdrawal initiated by the participants or physician.
Primary Outcome
To determine the response rate (RR) of CCA defined as objective responses (OR), i.e. complete and partial responses (CR, PR) plus stable disease (SD) of at least 4 months to treatment with ABC294640.
Conditions Studied
Interventions
- DRUG ABC294640
- DRUG Hydroxychloroquine Sulfate 200 MG
Study Locations (5)
Arizona
- Mayo Clinic Cancer Center - Phoenix
Georgia
- Emory University - Atlanta
Minnesota
- Mayo Clinic Cancer Center - Rochester
Texas
- MD Anderson Cancer Center - Houston
Utah
- Huntsman Cancer Institute, University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2018-03-07 |
| Est. Completion | 2022-06-21 |
| Phase | Phase 2 |
What the finished NCT03377179 record still lists
NCT03377179 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (83% lower).
The record links to 5 conditions, with Cholangiocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which ABC294640 is the first listed.
NCT03377179 lists 5 locations in 5 states (Arizona, Georgia, Minnesota).
Frequently Asked Questions
What is clinical trial NCT03377179 about?
NCT03377179 is a clinical study titled "A Study of ABC294640 Alone and in Combination With HCQ Sulfate in the Treatment of Advanced Cholangiocarcinoma". ABC-108 is a single-arm Phase IIA clinical study of ABC294640 (Yeliva ®, opaganib) alone and in combination with hydroxychloroquine sulfate (HCQ) in the treatment of cholangiocarcinoma (CCA). In Part 1 of this clinical study, all participants will be receiving ABC294640 and in Part 2 all participant...
What is the current status of trial NCT03377179?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2018-03-07. Estimated completion is 2022-06-21.
What conditions does trial NCT03377179 study?
This clinical trial studies the following conditions: Cholangiocarcinoma, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma Non-resectable, Cholangiocarcinoma, Perihilar, Cholangiocarcinoma, Extrahepatic.
What interventions are being tested in trial NCT03377179?
The interventions under investigation include: ABC294640 (DRUG), Hydroxychloroquine Sulfate 200 MG (DRUG).
Who is sponsoring clinical trial NCT03377179?
This trial is sponsored by RedHill Biopharma Limited, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03377179 being conducted?
This trial has 5 study locations across Arizona, Georgia, Minnesota, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03377179's enrollment target sits among peer trials
65 38th of 60 higher than 23 of 60 other Cholangiocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cholangiocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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