A Study of ABC294640 Alone and in Combination With HCQ Sulfate in the Treatment of Advanced Chola… (NCT03377179) | Clinical Trial Compass
CompletedPhase 2
A Study of ABC294640 Alone and in Combination With HCQ Sulfate in the Treatment of Advanced Cholangiocarcinoma
United States65 participantsStarted 2018-03-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with histologically confirmed intrahepatic, perihilar or extra-hepatic CCA.
✓. Patients with no more than 2 prior treatments with systemic anti-neoplastic therapy for CCA.
✓. The tumor is unresectable and not amenable to curative therapy.
✓. One or more tumors measurable on CT scan per RECIST 1.1.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0- 1.
✓. Life expectancy of at least 3 months.
✓. Age ≥18 years.
✓. Signed, written IRB-approved informed consent.
Exclusion criteria
✕. \>2 previous systemic anti-neoplastic regimens for CCA.
✕. Previously having received ABC294640 or HCQ (or chloroquine) for the treatment of a malignancy.
What they're measuring
1
Part1 - Determine Response Rate
Timeframe: At least 4 months
2
Part 2 - Determine the Durable Disease Control Rate
. New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG.
✕. Pregnant or nursing women. NOTE: If a woman became pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately.
✕. Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 28 days prior to study entry.
✕. Unwillingness or inability to comply with procedures required in this protocol.
✕. Known infection with human immunodeficiency virus.