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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03429803 | DAY101 In Gliomas and Other Tumors | PHASE1 | COMPLETED | 44 | — | — | Feb 27, 2018 | Dec 31, 2025 | Feb 19, 2026 | 15 | United States |
A DLT is defined as an AE assessed as at least possibly related to the study medication, which occurs during Cycle 1 (typically 28 days following the first dose of DAY101)
| Arm | Type | Description |
|---|---|---|
| DAY101 (formerly TAK-580, MLN2480) BSA </= 1.5m^2 | EXPERIMENTAL | Phase I Part B BSA \</= 1.5m\^2 * Patients (\< 25 years) with radiographically recurrent or radiographically progressive non-hematologic malignancies (Central Nervous System (CNS) or solid tumors) associated with activation of the RAS/RAF/MEK/ERK pathway will be eligible with the exception of patients with NF1 * Study treatment cycle lasts 28 days, oral, once a week |
| DAY101 (formerly TAK-580, MLN2480) BSA > 1.5m^2 | EXPERIMENTAL | Phase I Part B BSA \> 1.5m\^2 * Patients (\< 25 years) with radiographically recurrent or radiographically progressive non-hematologic malignancies (Central Nervous System (CNS) or solid tumors) associated with activation of the RAS/RAF/MEK/ERK pathway will be eligible with the exception of patients with NF1 * Study treatment cycle lasts 28 days, oral, once a week |
| Name | Type | Description |
|---|---|---|
| DAY101 | DRUG | 28 day cycle, oral, once per week |
Inclusion Criteria: * Participants must meet the following criteria on screening examination to be eligible to participate in the study: * Phase I * Pediatric patients with radiographically recurrent or radiographically progressive non-hematologic malignancies (Central Nervous System (CNS) ...