LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)

Inclusion Criteria:

Patient had a confirmed diagnosis of a select solid tumor (except breast cancer (however, triple negative was included), liposarcoma, CRPC, melanoma and teratoma) or hematological malignancy (except mantle cell lymphoma).
Patient must have been pre-identified as having a tumor with CDK4 amplification or mutation, CDK6 amplification or mutation, Cyclin D1 (CCND1) amplification, Cyclin D3 (CCND3) amplification, or p16 (CDKN2A) mutation
Patient had received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
Patient had progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.
Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

Patients had received prior treatment with LEE011.
Patient had clinically significant resting bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval > 109 msec, or QTcF > 450 msec.
Patients had primary CNS tumor or CNS tumor involvement
Patient had received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting study drug