Approval Probability
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BYL719 · 1 trial · 3 indications
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...
BYL719 is an investigational small molecule being studied for the treatment of advanced and selected solid tumors, including acute myeloid leukemia (AML) and high risk and very high risk myelodysplastic syndromes (MDS). It is currently in Phase 1 clinical development and is not approved by the FDA.
BYL719 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for oncology indications.
BYL719 is in Phase 1 clinical development. It has completed one Phase 1 trial, and it remains an investigational drug that has not been approved by the FDA. The completed trial enrolled 139 participants.
BYL719 has been studied in one clinical trial, identified as NCT01449058. This was a Phase Ib study of MEK162 plus BYL719 in adult patients with selected advanced solid tumors, including AML and high risk and very high risk MDS. The trial was completed and enrolled 139 participants.
No, BYL719 is not the same as MEK162. BYL719 is the investigational drug being developed by Pfizer, while MEK162 is a separate drug that was studied in combination with BYL719 in the clinical trial NCT01449058. The trial evaluated the two drugs together in patients with advanced solid tumors.