Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Colorectal Cancer, Skin Cancer, Ovarian Cancer, Liver Cancer, Cancer, Brain Cancer, Brain Cancer, Lymphoma, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:November 19, 2015
End Date:October 31, 2020
Contact:Reference Study ID Number: GO40782 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for
the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene
fusion. Patients will be assigned to different baskets according to tumor type and gene
fusion.


Inclusion Criteria:

- Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic
solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement

- Note: Patients diagnosed with anaplastic large cell lymphoma (ALCL) harboring a gene
rearrangement of interest may be eligible provided they meet all other
inclusion/exclusion criteria

- For patients enrolled via local molecular testing, an archival or fresh tumor tissue
(unless medically contraindicated) is required to be submitted for independent central
molecular testing at Ignyta's CLIA laboratory post-enrollment

- Measurable or evaluable disease

- Patients with CNS involvement, including leptomeningeal carcinomatosis, which is
either asymptomatic or previously-treated and controlled, are allowed

- Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1,
or ALK inhibitors in patients who have tumors that harbor those respective gene
rearrangements)

- Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged
NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are
prohibited.

- At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior
chemotherapy or small molecule targeted therapy

- At least 4 weeks must have elapsed since completion of antibody-directed therapy

- Prior radiotherapy is allowed if more than 14 days have elapsed since the end of
treatment

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and minimum life
expectancy of 4 weeks

- Adequate organ function as defined per protocol

- Ability to swallow entrectinib intact

- Other protocol specified criteria

Exclusion Criteria:

- Current participation in another therapeutic clinical trial

- Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in
patients who have tumors that harbor those respective gene rearrangements

- Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged
NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are
prohibited.

- History of other previous cancer that would interfere with the determination of safety
or efficacy

- Incomplete recovery from any surgery

- History of non-pharmacologically induced prolonged QTc interval

- History of additional risk factors for torsade de pointes

- Peripheral neuropathy Grade ≥ 2

- Known active infections

- Active gastrointestinal disease or other malabsorption syndromes

- Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase
inhibitor-induced pneumonitis

- Other protocol specified criteria
We found this trial at
55
sites
Newnan, Georgia 30265
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Dale Shepard, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Dr. Rom Leidner
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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201 Borella Road
Albury, New South Wales 2640
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: John Krauss, MD
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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3320 Old Jefferson Road
Athens, Georgia 30607
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Atlanta, Georgia 30322
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Aurora, Colorado 80045
Principal Investigator: Robert Doebele, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Charlotte, North Carolina 28211
Principal Investigator: Edward Kim, MD
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303 East Superior Street
Chicago, Illinois 60611
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Columbus, Ohio 43210
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Detroit, Michigan 48202
Principal Investigator: Shirish Gadgeel, MD
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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20 Duke Clinic Cir
Durham, North Carolina 27710
(888) 275-3853
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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235 North Belle Mead Avenue
East Setauket, New York 11733
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Alexander Spira, MD
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Franklin, Wisconsin 53132
Principal Investigator: Jonathan Treisman, MD
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14200 Celebrate Life Way
Goodyear, Arizona 85338
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Hampton, Virginia 23666
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Honolulu, Hawaii 96813
Principal Investigator: Jared Acoba, MD
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Houston, TX
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La Jolla, CA
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10666 N Torrey Pines Rd
La Jolla, California 92037
(858) 554-9100
Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Mary Chamberlin, MD
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Los Angeles, California 90033
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Minneapolis, Minnesota 55455
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Hari Deshpande, MD
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Alexander Drilon, MD
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Saint Louis, Missouri 63110
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Salt Lake City, Utah 84132
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10990 San Diego Mission Road
San Diego, California 92108
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San Francisco, California 94143
Principal Investigator: Collin Blakely, MD
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Santa Monica, California 90403
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Sarasota, Florida 34232
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Scottsdale, Arizona 85259
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Seattle, Washington 98109
Principal Investigator: Elena Chiorean, MD
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Temple, Texas 76508
Principal Investigator: Sherronda Henderson, MD
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Washington, District of Columbia 20057
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Zion, Illinois 60099
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