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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01449058 | A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors | PHASE1 | COMPLETED | 139 | — | — | Mar 1, 2012 | Aug 15, 2017 | Oct 2, 2017 | 16 | United States, Australia +5 |
Toxicity will be assessed using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0 unless otherwise specified. A DLT is defined as an adverse event or abnormal laboratory value assessed as at least possibly related to the study medication, occurs ≤ 28 days following the first dose of BYL719 and MEK162 (Cycle 1), and meets any of the protocol-specified DLT criteria.
| Arm | Type | Description |
|---|---|---|
| BYL719 + MEK162 | EXPERIMENTAL | BYL719 plus MEK162. Dose escalation with a starting dose for the first cohort of 200mg QD BYL719 and 30mg BID MEK162 |
| Name | Type | Description |
|---|---|---|
| BYL719 | DRUG | taken orally |
| MEK162 | DRUG | taken orally |
Inclusion Criteria: * Histologically/cytologically confirmed, advanced solid tumors, AML or high risk and very high risk MDS * Measurable disease as determined by RECIST 1.1 Exclusion Criteria: * Primary CNS tumor or CNS tumor involvement * Diabetes mellitus * Unacceptable ocular/retinal conditio...