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

Completed · Phase 2

Conditions studied: Tumors With CDK4/6 Pathway Activation

In brief

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 warrant further study.

Key facts

Study ID

NCT02187783

Run by

Novartis Pharmaceuticals

People needed

106

Starts

2014-08-25

Expected to finish

2018-01-17

Last updated by the study team

2019-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alaska Clinical Research — Anchorage, Alaska, United States
• Arizona Oncology Associates Dept. Of Onc. — Phoenix, Arizona, United States
• University of Arkansas/ Arkansas Cancer Research Center UA Medical Sciences — Little Rock, Arkansas, United States
• PCR Oncology — Pismo Beach, California, United States
• University of California Davis Cancer Center UC Davis Cancer (3) — Sacramento, California, United States
• Sarah Cannon Research Institute — Denver, Colorado, United States
• Danbury Hospital — Danbury, Connecticut, United States
• Yale University School of Medicine Smilow Cancer Hospital — New Haven, Connecticut, United States
• Whittingham Cancer Center Norwalk Hospital — Norwalk, Connecticut, United States
• Stamford Hospital Med. Oncology Hematology Res. — Stamford, Connecticut, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• NorthWest Georgia Oncology Centers NW Georgia Oncology — Marietta, Georgia, United States
• Harbin Clinic Medical Oncology Clin. Res. — Rome, Georgia, United States
• Queen's Medical Center Queens Cancer Center — Honolulu, Hawaii, United States
• Northwestern Medicine Developmental Therapeutics Institute — Chicago, Illinois, United States
• Indiana University Indiana Univ. - Purdue Univ. — Indianapolis, Indiana, United States
• Northern Indiana Cancer Research Consortium No. Indiana Cancer Res. — South Bend, Indiana, United States
• University of Iowa Hospitals & Clinics Regulatory Contact 2 — Iowa City, Iowa, United States
• New England Cancer Specialists — Scarborough, Maine, United States
• St. Agnes Hospital St. Agnes Hospital (2) — Baltimore, Maryland, United States
• Michigan Medicine University of Michigan Int. Medicine Oncology — Ann Arbor, Michigan, United States
• Cancer and Hematology Centers of West Michigan Dept. of Oncology — Grand Rapids, Michigan, United States
• Saint Luke's Hospital/Marion Bloch Neuroscience Institute St. Luke's Hospital (4) — Kansas City, Missouri, United States
• Research Medical Center Research Med Center (2) — Kansas City, Missouri, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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