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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01822691 | Phase II INCB024360 Study for Patients With Myelodysplastic Syndromes (MDS) | PHASE2 | COMPLETED | 15 | — | — | Jul 1, 2013 | Feb 1, 2015 | Jan 18, 2016 | 1 | United States |
ORR, measured by Response Criteria for Patients with Myelodysplastic Syndrome (MDS). According International Working Group (IWG) 2006 criteria (Cheson et al, 2006). Complete Remission (CR), Partial Remission (PR), Marrow CR, and Hematological Improvement (HI)(any cell line). Stable Disease (SD): Failure to achieve at least PR, but no evidence of progression for \> 8 weeks.
| Arm | Type | Description |
|---|---|---|
| INCB024360 Treatment | EXPERIMENTAL | Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident. |
| Name | Type | Description |
|---|---|---|
| INCB024360 | DRUG | INCB024360 is an inhibitor of the enzyme indoleamine 2,3-dioxygenase (IDO) that is proposed for development for the treatment of malignant diseases. Participants were to receive the study drug in 28 day (4 week) cycles of treatment. |
Inclusion Criteria: * Confirmed diagnosis of myelodysplastic syndromes (MDS) * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Adequate organ function: * Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN) * Aspartic transaminase (AST)/alanine transaminase (ALT) ≤ 2.5 × ULN ...