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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01563302 | Phase 1/2, Open-label, Dose-escalation Study of IONIS-STAT3Rx, Administered to Patients With Advanced Cancers | PHASE1 | COMPLETED | 64 | — | — | Feb 27, 2012 | Mar 23, 2016 | Jun 25, 2018 | 9 | United States |
Highest dose level at which no more than 1 out of 6 patients develops a DLT
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | IONIS-STAT3Rx |
| Name | Type | Description |
|---|---|---|
| IONIS-STAT3Rx | DRUG | Three-hour IV infusions on Cycle 0 Days 1, 3, 5, and weekly three-hour IV infusions in Cycles 1 and beyond, on Days 1, 8, and 15 of each cycle. |
Inclusion Criteria: * Aged 18 years or older * Tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists * Expansion cohort only: Advanced lymphoma confirmed by histopathology * Measurable or evaluable disease according to RECIS...