The purpose of this signal seeking study is to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to warrant further study.
|First Received Date||July 9, 2014|
|Last Changed Date||June 22, 2018|
|Start Date||August 25, 2014|
|Actual Primary Completion Date||October 31, 2017|
|Primary Outcome Measures||
Clinical benefit rate associated with LEE011 treatment [Time Frame: 16 weeks]
|Secondary Outcome Measures||
Overall Response (OR) of Partial Response (PR) or greater [Time Frame: Baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months]
Progression Free Survival (PFS) [Time Frame: Every 8 weeks until death, assessed up to 24 months]
Overall Survival (OS) [Time Frame: Every 8 weeks until death, assessed up to 36 months]
Duration of Response (DOR) [Time Frame: Baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months]
Safety and tolerability [Time Frame: Baseline up to 30 days after last study treatment]
|Study Arms / Comparison Groups||1 / 0|
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
- 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
- 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
|Verification Date||June 2018|