Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SK2 inhibitor ABC294640
sphingosine kinase-2 inhibitor ABC294640 · 1 trial · 2 indications
MTD defined as the highest dose at which 0 or 1 patient of 6 experiences a DLT. The DLT rate will be estimated with its 95% confidence interval.
Assessed using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 4.0. Adverse events (AEs) will be coded by body system and summary tables with incidence rates of adverse events will be generated. Descriptive statistics of AEs will be reported by doses and for subsets of patients with serious adverse events (SAEs), patients who discontinue due to AEs, and patients with related AEs.
| Arm | Type | Description |
|---|---|---|
| Treatment (enzyme inhibitor therapy) | EXPERIMENTAL | Patients receive sphingosine kinase-2 inhibitor ABC294640 PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| sphingosine kinase-2 inhibitor ABC294640 | DRUG | Given PO Starting dose of ABC294640 250 mg once on day on Days 1-28 of each 28-day cycle. Subsequent cohort doses (if reached) are as follows: 250 BID, 500 BID, 750 BID, 1,000 BID, 1,500 BID, 2,000 BID, 2,500 BID |
Inclusion Criteria: * PART I: * Patients with histologically confirmed solid organ carcinomas * Tumor progression after receiving standard/approved chemotherapy or as first-line therapy for malignancies where there is no standard therapy * One or more tumors measurable on computed tomography (CT) s...
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ABC294640 is an investigational small molecule being studied for the treatment of pancreatic cancer. It was evaluated in a Phase 1 clinical trial in patients with advanced solid tumors, including pancreatic cancer. The drug is not approved and remains in clinical development.
ABC294640 is a sphingosine kinase-2 inhibitor. It works by inhibiting the activity of sphingosine kinase-2, an enzyme involved in cell signaling pathways that can promote tumor growth. This mechanism is being explored as a potential therapeutic approach for pancreatic cancer.
ABC294640 is being developed by Redhill Biopharma Ltd., a biopharmaceutical company. The company's stock is traded under the ticker symbol RDHL. Redhill Biopharma is conducting clinical research on this investigational drug for oncology indications.
ABC294640 is in Phase 1 clinical development. It has completed a Phase 1 trial in patients with advanced solid tumors, including pancreatic cancer. The drug is investigational and has not received FDA approval for any indication.
ABC294640 has been studied in one completed Phase 1 clinical trial with the identifier NCT01488513. The trial, titled 'ABC294640 in Treating Patients With Advanced Solid Tumors,' enrolled 22 participants in the United States and included patients with pancreatic cancer and other advanced solid tumors.