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Enzyme Inhibitor

ABC294640 for Bile Duct Cancer

Phase 2
Waitlist Available
Led By Mitesh Borad, MD
Research Sponsored by RedHill Biopharma Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to treatment till the end of study (assessed at screening, beginning of cycle three of treatment and every 8 weeks thereafter, up to 24 months)
Awards & highlights

Study Summary

This trial is exploring whether the combination of ABC294640 and hydroxychloroquine sulfate is more effective than ABC294640 alone in treating cholangiocarcinoma.

Eligible Conditions
  • Bile Duct Cancer
  • Cholangiocarcinoma
  • Intrahepatic Cholangiocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to treatment till the end of study (assessed at screening, beginning of cycle three of treatment and every 8 weeks thereafter, up to 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to treatment till the end of study (assessed at screening, beginning of cycle three of treatment and every 8 weeks thereafter, up to 24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 2 - Determine the Durable Disease Control Rate
Part1 - Determine Response Rate
Secondary outcome measures
A general neurological exam to measure safety and tolerability of ABC294640 alone and in combination with HCQ
Daily diary entries to aid in asessing safety and tolerability of ABC294640 alone and in combination with HCQ
Determine Disease Control Rate (DCR=CR+PR+SD)
+9 more
Other outcome measures
Determine the effect of treatment with ABC294640 alone or in combination with HCQ on pharmacodynamic markers that are associated with the mechanism of action of the drug.
Serial measurement of circulating tumor DNA (ctDNA)

Side effects data

From 2021 Phase 4 trial • 93 Patients • NCT03122431
60%
Only sensory peripheral neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
SLE/Cutaneous Lupus With Thalidomide
Inactive SLE With Standard Dose of HCQ
Inactive SLE With Reduced Dose of HCQ

Trial Design

1Treatment groups
Experimental Treatment
Group I: ABC294640 +/- HCQ treatmentExperimental Treatment2 Interventions
Part 1: All participants will be receiving ABC294640, 500 mg twice a day (BID), continuously in 28 day cycles Part 2: All participants will be receiving ABC294640, 500 mg twice a day (BID) and HCQ at a determined level, continuously in 28 day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABC294640
2018
Completed Phase 2
~70
Hydroxychloroquine Sulfate 200 MG
2018
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

RedHill Biopharma LimitedLead Sponsor
19 Previous Clinical Trials
3,005 Total Patients Enrolled
Mitesh Borad, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
285 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of ABC294640 (Yeliva ®) Alone and in Combination With Hydroxychloroquine Sulfate in Treatment of Patients With Advanced Cholangiocarcinoma
2018. "A Study of ABC294640 (Yeliva ®) Alone and in Combination With Hydroxychloroquine Sulfate in Treatment of Patients With Advanced Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03377179.
~9 spots leftby Apr 2025
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