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

Inclusion Criteria:

- Patient has a confirmed diagnosis of a select solid tumor (except breast cancer
(however, triple negative will be 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 has 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 has progressive and measurable disease as per RECIST 1.1. or other appropriate
hematological guidelines.

- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

- Patients has received prior treatment with LEE011.

- Patient has 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 has primary CNS tumor or CNS tumor involvement

- Patient has received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting
study drug