Pancreatic Cancer Clinical Trial
Official title:
A Phase I, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of ABC294640 in Patients With Advanced Solid Tumors
This phase I trial studies the side effects and best dose of ABC294640 in treating patients with advanced solid tumors. ABC294640 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Please note that the FDA OOPD is participating as a funding source.
PRIMARY OBJECTIVES:
I. To assess safety and determine the maximum tolerated dose (MTD) and the dose limiting
toxicities (DLT) of ABC294640 (sphingosine kinase-2 inhibitor ABC294640) in patients with
solid organ tumors. (Part I) II. To assess the safety and tolerability of ABC294640 at the
MTD in an expanded cohort of hepatocellular carcinoma (HCC) patients. (Part II)
SECONDARY OBJECTIVES:
I. To establish the dose of ABC294640 recommended for future phase II protocols. (Part I) II.
To describe the pharmacokinetics of ABC294640 in patients with solid organ tumors. (Part I)
III. To describe the effects of ABC294640 on plasma levels of sphingosine 1-phosphate in
patients with solid organ tumors. (Part I) IV. To assess antitumor activity of ABC294640 in
patients with solid organ tumors by objective radiographic assessment using Response
Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. (Part I) V. To describe the
pharmacokinetics of ABC294640 in HCC patients. (Part II) VI. To describe the effects of
ABC294640 on plasma levels of sphingosine 1-phosphate in HCC patients. (Part II) VII. To
assess antitumor activity of ABC294640 in HCC patients by objective radiographic assessment
using RECIST 1.1 criteria. (Part II)
OUTLINE: This is a dose-escalation study.
Patients receive sphingosine kinase-2 inhibitor ABC294640 orally (PO) twice daily (BID) on
days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up monthly for 1 year.
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