A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/9/2019 |
Start Date: | October 3, 2014 |
End Date: | September 20, 2019 |
JUNIPER: A Randomized Phase 3 Study of Abemaciclib Plus Best Supportive Care Versus Erlotinib Plus Best Supportive Care in Patients With Stage IV NSCLC With a Detectable KRAS Mutation Who Have Progressed After Platinum-Based Chemotherapy
The main purpose of this study is to evaluate how safe and effective the study drug known as
abemaciclib is in participants with lung cancer.
abemaciclib is in participants with lung cancer.
Inclusion Criteria:
- Have confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) according to
the American Joint Committee on Cancer Staging Handbook.
- Determined to have detectable mutations in codons 12 or 13 of the kirsten rat sarcoma
(KRAS) oncogene by an investigational assay at the study central laboratory. A KRAS
positive mutation result in codons 12 or 13 of the KRAS oncogene from tumor tissue per
local laboratory will be permitted in no more than 10% of randomized participants.
- Have progressed after platinum-based chemotherapy (with or without maintenance
therapy) AND have received one additional therapy which may include an immune
checkpoint inhibitor or other anti-cancer therapy for advanced and/or metastatic
disease OR is judged by the physician as ineligible for further standard second-line
chemotherapy. Participants who have progressed after platinum-based chemotherapy and
an immune checkpoint inhibitor (immunotherapy) e.g. pembrolizumab or nivolumab alone
or in combination with other agents are eligible.
- Have measureable disease as defined by the Response Evaluation Criteria in Solid
Tumors (RECIST 1.1).
- Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group
(ECOG) scale.
- Have discontinued all previous therapies for cancer (including chemotherapy,
radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for
myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving
study drug.
Exclusion Criteria:
- Have received treatment with a drug that has not received regulatory approval for any
indication within 14 or 21 days of the initial dose of study drug for a
nonmyelosuppressive or myelosuppressive agent, respectively.
- Have a personal history of any of the following conditions: presyncope or syncope of
either unexplained or cardiovascular etiology, ventricular arrhythmia (including but
not limited to ventricular tachycardia and ventricular fibrillation), or sudden
cardiac arrest.
- Have the presence of unstable central nervous system (CNS) metastasis. History of CNS
metastasis or stable CNS metastases is allowed (no longer requiring active therapy
such as steroid medications). Participants with a history of CNS metastases must have
a brain scan (for example, magnetic resonance imaging [MRI]) within 28 days of
randomization to document stability, even if there have been no changes in symptoms.
- Have previously completed or withdrawn from this study or any other study
investigating a cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6)
inhibitors, or have received treatment with a prior CDK4 and CDK6 inhibitors.
We found this trial at
57
sites
Athens, Georgia 30607
Principal Investigator: Petros Nikolinakos
Phone: 706-353-2990
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1045 North 30th Street
Billings, Montana 59101
Billings, Montana 59101
406-255-8470
Principal Investigator: Pamela Smith
Phone: 406-238-2500
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101 Jessup Hall
Iowa City, Iowa 52242
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Muhammad Furqan
Phone: 319-384-9502
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Bakersfield, California 93309
Principal Investigator: David Kanamori
Phone: 661-862-7158
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Bethesda, Maryland
Principal Investigator: Christina Brzezniak
Phone: 301-319-2166
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Boca Raton, Florida 33486
Principal Investigator: Edgardo Santos
Phone: 561-955-5156
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111 Colchester Ave
Burlington, Vermont 05401
Burlington, Vermont 05401
(802) 847-0000
Principal Investigator: Farrah Khan
Phone: 802-847-8400
Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
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Charleston, South Carolina 29401
Principal Investigator: Steve Akman
Phone: 843-958-2664
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Chattanooga, Tennessee 37404
Principal Investigator: Davey Daniel
Phone: 423-698-1844
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5053 Wooster Rd
Cincinnati, Ohio 45226
Cincinnati, Ohio 45226
(513) 751-2273
Principal Investigator: David Waterhouse
Phone: 513-891-4800
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Daytona Beach, Florida 32114
Principal Investigator: Ruby Anne Deveras
Phone: 386-254-4212
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Detroit, Michigan 48201
Principal Investigator: Gerold Bepler
Phone: 313-576-8665
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Marianna Koczywas
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Englewood, Colorado 80112
Principal Investigator: Catholic Health Initiatives
Phone: 720-784-1304
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Fayetteville, Arkansas 72703
Principal Investigator: Eric Schaefer
Phone: 479-587-1700
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Framingham, Massachusetts 01701
Principal Investigator: Kala Seetharaman
Phone: 508-383-8406
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Fullerton, California 92835
Principal Investigator: William Lawler
Phone: 714-446-5804
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1 Ingalls Dr
Harvey, Illinois 60426
Harvey, Illinois 60426
(708) 333-2300
Principal Investigator: James Wallace
Phone: 708-915-6119
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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340 W 10th St #6200
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 274-3772
Principal Investigator: LAWRENCE EINHORN
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Johnson City, New York 13790
Principal Investigator: Ronald Harris
Phone: 607-763-6850
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Joplin, Missouri 64804
Principal Investigator: Kerry Williams-Wuch
Phone: 417-347-4000
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7360 W. Deschutes
Kennewick, Washington 99336
Kennewick, Washington 99336
509-783-0144
Principal Investigator: Ying Zhuo
Phone: 509-783-4637
Columbia Basin Hematology and Oncology Our collaboration with Seattle Cancer Care Alliance gives you convenient...
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9500 Gilman Dr
La Jolla, California 92093
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Lyudmila Bazhenova
Phone: 858-822-6189
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 650-5000
Principal Investigator: Konstantin Dragnev
Phone: 603-650-6344
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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1740 Nicholasville Rd
Lexington, Kentucky 40503
Lexington, Kentucky 40503
(859) 260-6100
Principal Investigator: Firas Badin
Phone: 859-260-3197
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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Lexington, Kentucky 40509
Principal Investigator: Jessica Croley
Phone: 859-629-7110
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Loma Linda, California 92354
Principal Investigator: Hamid Mirshahidi
Phone: 909-558-3375
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Los Angeles, California 90024
Principal Investigator: TRIO -Translational Research
Phone: 310-824-1934
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Los Angeles, California 90095
Principal Investigator: Jonathan Goldman
Phone: 310-633-8400
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Louisville, Kentucky 40202
Principal Investigator: Kuda Dad Kahn
Phone: 502-210-4247
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500 S Preston St
Louisville, Kentucky
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Goetz Kloecker
Phone: 502-562-4358
University of Louisville The University of Louisville is a state supported research university located in...
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Nashville, Tennessee 37203
Principal Investigator: Sarah Cannon Research Inst.
Phone: 615-329-7615
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: David Spigel
Phone: 615-329-7274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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New York, New York 10021
Principal Investigator: Ronald Scheff
Phone: 646-962-2066
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Newark, Delaware
Principal Investigator: Michael Guarino
Phone: 302-733-6227
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Omaha, Nebraska 68122
Principal Investigator: Samer Renno
Phone: 402-572-3535
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Principal Investigator: Timothy Burns
Phone: 412-648-6577
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Redondo Beach, California 90277
Principal Investigator: Thomas Lowe
Phone: 310-750-3376
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Sherman Baker
Phone: 804-828-0422
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Sacramento, California 95816
Principal Investigator: Samer Shihabi
Phone: 530-668-2600
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Salt Lake City, Utah 84106
Principal Investigator: Stephan Kendall
Phone: 801-281-6864
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Santa Monica, California 93454
Principal Investigator: Robert Dichmann
Phone: 805-739-3724
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5300 Tallman Ave NW
Seattle, Washington 98122
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Howard West
Phone: 206-386-2424
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Springfield, Missouri 65807
Principal Investigator: Jessica Snider
Phone: 417-820-8099
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Tampa, Florida 33612
Principal Investigator: Jhanelle Gray
Phone: 813-745-8372
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Tulsa, Oklahoma 74146
Principal Investigator: Steven Buck
Phone: 918-505-3200
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Valley, Washington 99216
Principal Investigator: Danko Martincic
Phone: 509-228-1200
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818 N. Emporia, #403
Wichita, Kansas 67214
Wichita, Kansas 67214
(316) 262-4467
Principal Investigator: Shaker Dakhil
Phone: 316-262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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