Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01488513 | ABC294640 in Treating Patients With Advanced Solid Tumors | PHASE1 | COMPLETED | 22 | — | — | Aug 1, 2011 | Jul 1, 2015 | Jan 7, 2020 | 1 | United States |
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...