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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01787552 | A Phase Ib/II Dose-finding Study to Assess the Safety and Efficacy of LDE225 + INC424 in Patients With MF | PHASE1 | COMPLETED | 50 | — | — | May 8, 2013 | Apr 10, 2018 | Apr 15, 2020 | 18 | Australia, Belgium +9 |
A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
Reduction in spleen volume as measured by magnetic resonance imaging/Cat Scan (MRI/CT) in Phase Ib expansion and Phase II Stage 1 patients
| Arm | Type | Description |
|---|---|---|
| LDE225 + INC424 | EXPERIMENTAL | LDE225 and INC424 in combination |
| Name | Type | Description |
|---|---|---|
| LDE225 | DRUG | - |
| INC424 | DRUG | - |
Inclusion Criteria: * Diagnosed with PMF per 2008 WHO criteria, post-PV MF or post-ET MF per IWG-MRT criteria. * Ineligible or unwilling to undergo stem cell transplantion. * PLT counts \> or = 75X 10\^9/L not reached with the aid of transfusions. * ECOG performance status ≤ 2. * Palpable splenomeg...