LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/28/2018 |
Start Date: | August 25, 2014 |
End Date: | January 17, 2018 |
Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 8 - LEE011 for Patients With CDK4/6 Pathway Activated Tumors
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.
demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic
malignancies to warrant further study.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
61
sites
Salt Lake City, Utah 84106
Principal Investigator: Stephan D. Kendall
Phone: 801-281-6864
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Albuquerque, New Mexico 87110
Principal Investigator: Bernard Mawulorm Agbemadzo
Phone: +1 505 559 6100
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Anchorage, Alaska 99503
Principal Investigator: William R. Clark
Phone: 907-276-1455
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Baltimore, Maryland 21229
Principal Investigator: Carole Miller
Phone: 410-368-2909
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Chattanooga, Tennessee 37404
Principal Investigator: Edward Riker Arrowsmith
Phone: +1 423 698 1844
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Cleveland, Ohio 44195
Principal Investigator: Davendra Sohal
Phone: 216-444-8258
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Denver, Colorado 80218
Principal Investigator: Gerald Falchook
Phone: 720-754-2610
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Hickory, North Carolina 28602
Principal Investigator: Richard Orlowski
Phone: 828-324-9550
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Houston, Texas 77030
Principal Investigator: Vivek Subbiah
Phone: 216-255-2748
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Indianapolis, Indiana 46202
Principal Investigator: Bert O'Neil
Phone: 317-278-8845
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Kansas City, Missouri 64132
Principal Investigator: Jaswinder Singh
Phone: 816-276-4227
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Kansas City, Missouri 64111
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Kennewick, Washington 99336
Principal Investigator: Ying Zhuo
Phone: 509-783-4637
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Little Rock, Arkansas 72205
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Milwaukee, Wisconsin 53226
Principal Investigator: Michael A. Thompson
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8800 W. Doyne Avenue
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 805-6840
Principal Investigator: Ben George
Phone: 414-805-6803
Medical College of Wisconsin Cancer Center Cancer touches everyone in our community, and for many,...
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Murray, Utah 84157
Principal Investigator: Lincoln Nadauld
Phone: 435-688-4900
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New Haven, Connecticut 06520
Principal Investigator: Joseph Paul Eder
Phone: +1 203 737 1906
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333 Cottman Avenue
Philadelphia, Pennsylvania 19111
Philadelphia, Pennsylvania 19111
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Phoenix, Arizona
Principal Investigator: Mahesh Seetharam
Phone: 602-274-5141
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Pismo Beach, California 93449
Principal Investigator: David Palchak
Phone: 805-474-9143
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Providence, Rhode Island 02903
Principal Investigator: Howard Safran
Phone: 401-444-3059
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Sacramento, California 95817
Principal Investigator: Karen Kelly
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San Antonio, Texas 78229
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900 East 54th Street North
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
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South Bend, Indiana 46617
Principal Investigator: Jose A. Bufill
Phone: 574-237-1328
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Stamford, Connecticut 06902
Principal Investigator: Salvatore Del Prete
Phone: 203-325-2695
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Tacoma, Washington 98405
Principal Investigator: John A. Keech
Phone: 253-403-2554
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Tacoma, Washington 98405
Principal Investigator: Sibel Blau
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Winchester, Virginia 22601
Principal Investigator: William A. Houck
Phone: 540-662-1108
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
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