Status:
COMPLETED
LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Tumors With CDK4/6 Pathway Activation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this signal seeking study was to determine whether treatment with LEE011 demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic malignancies to war...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 25 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2018
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT02187783
Start Date
August 25 2014
End Date
January 17 2018
Last Update
July 18 2019
Active Locations (61)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
Alaska Clinical Research
Anchorage, Alaska, United States, 99503
3
Arizona Oncology Associates Dept. Of Onc.
Phoenix, Arizona, United States
4
University of Arkansas/ Arkansas Cancer Research Center UA Medical Sciences
Little Rock, Arkansas, United States, 72205