LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)
NCT ID: NCT02187783
Last Updated: 2019-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
106 participants
INTERVENTIONAL
2014-08-25
2018-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LEE011
LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.
LEE011
Study drug was provided in 200 mg and 50 mg hard gelatin capsules to be taken orally
Interventions
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LEE011
Study drug was provided in 200 mg and 50 mg hard gelatin capsules to be taken orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
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
Comprehensive Cancer Centers of Nevada CCC of Nevada- Southwest (2)
Las Vegas, Nevada, United States
Cooper Health System Cooper Health System (5)
Camden, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
Cancer Center at Presbyterian
Albuquerque, New Mexico, United States
Broome Oncology Broome Oncology (2)
Johnson City, New York, United States
University of N C at Chapel Hill Physician Office Building
Chapel Hill, North Carolina, United States
Carolina Oncology Specialists, PC
Hickory, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Oncology Hematology Care Inc Oncology Hematology Care 2
Cincinnati, Ohio, United States
Cleveland Clinic Foundation Taussig Cancer Institute
Cleveland, Ohio, United States
Ohio State University Medical Center Comprehensive Cancer Center
Columbus, Ohio, United States
Oregon Health and Science University Oregon Health & Science U (56)
Portland, Oregon, United States
Salem Health
Salem, Oregon, United States
Fox Chase Cancer Center Dept of Medical Oncology
Philadelphia, Pennsylvania, United States
Rhode Island Hospital Rhode Island Hosp. (2)
Providence, Rhode Island, United States
Greenville Health System ITOR - Cancer Institute
Greenville, South Carolina, United States
Sanford University of South Dakota Medical Center Sanford Health
Sioux Falls, South Dakota, United States
Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
Chattanooga, Tennessee, United States
The West Clinic Dept. of the West Clinic
Memphis, Tennessee, United States
Tennessee Oncology Tennessee Oncology (3)
Nashville, Tennessee, United States
Coastal Bend Cancer Center
Corpus Christi, Texas, United States
Oncology Consultants Oncology Group
Houston, Texas, United States
MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3)
Houston, Texas, United States
University of Texas Health Science Center at San Antonio Cancer Therapy & Research Ctr.
San Antonio, Texas, United States
Intermountain Medical Center Intermountain Healthcare
Murray, Utah, United States
Utah Cancer Specialists Utah Cancer Specialists (11)
Salt Lake City, Utah, United States
Shenandoah Oncology Shenadoah Oncology (2)
Winchester, Virginia, United States
Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc
Kennewick, Washington, United States
Vista Oncology Inc. PS
Olympia, Washington, United States
Multicare Research Institute
Tacoma, Washington, United States
Northwest Medical Specialties Rainier Physicians, PC
Tacoma, Washington, United States
Providence St. Mary Regional Cancer Center
Walla Walla, Washington, United States
Wenatchee Valley Medical Center Wenatchee Valley
Wenatchee, Washington, United States
Aurora Research Institute Aurora Health Care
Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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CLEE011XUS03
Identifier Type: -
Identifier Source: org_study_id
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