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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)
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
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.
- - 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.
- - 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.
- - History of other previous cancer that would interfere with the determination of safety or efficacy.
- - Familial or personal history of congenital bone disorders, or bone metabolism alterations.
- - Incomplete recovery from any surgery.
- - History of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction ≤50% observed during screening for the study.
- - History of non-pharmacologically induced prolonged QTc interval.
- - History of additional risk factors for torsades 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.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02568267 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Hoffmann-La Roche |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Clinical Trials |
| Principal Investigator Affiliation | Hoffmann-La Roche |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Australia, Belgium, China, France, Germany, Hong Kong, Italy, Japan, Netherlands, Poland, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Breast Cancer, Cholangiocarcinoma, Colorectal Cancer, Head and Neck Neoplasms, Lymphoma, Large-Cell, Anaplastic, Melanoma, Neuroendocrine Tumors, Non-Small Cell Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Papillary Thyroid Cancer, Primary Brain Tumors, Renal Cell Carcinoma, Sarcomas, Salivary Gland Cancers, Adult Solid Tumor |
Arms
Experimental: NTRK1/2/3-rearranged NSCLC
Oral entrectinib (RXDX-101)
Experimental: ROS1-rearranged NSCLC
Oral entrectinib (RXDX-101)
Experimental: ALK- or ROS1-rearranged NSCLC
with CNS-only progression previously treated with crizotinib (NOTE: The ALK-rearranged portion of this arm is now closed to enrollment.) Oral entrectinib (RXDX-101)
Experimental: NTRK/1/2/3-rearranged mCRC
Oral entrectinib (RXDX-101)
Experimental: ROS1-rearranged mCRC
Oral entrectinib (RXDX-101)
Experimental: ALK-rearranged mCRC
Oral entrectinib (RXDX-101)
Experimental: NTRK1/2/3-rearranged other solid tumor
Oral entrectinib (RXDX-101)
Experimental: ROS1-rearranged other solid tumor
Oral entrectinib (RXDX-101)
Experimental: ALK-rearranged other solid tumor
Oral entrectinib (RXDX-101)
Interventions
Drug: - Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Dignity Health St Joseph's Hospital and Medical Center
Phoenix 5308655, Arizona 5551752, 85013
Status
Address
Mayo Clinic
Phoenix 5308655, Arizona 5551752, 85054
Status
Address
City of Hope Cancer Center
Duarte 5344147, California 5332921, 91010
Status
Address
City of Hope Duarte - Comprehensive Cancer Center, Investigational Drug Services
Duarte 5344147, California 5332921, 91010
Status
Address
Scripps Clinic
La Jolla 5363943, California 5332921, 92037
Status
Address
University of California San Diego Moores Cancer Center
La Jolla 5363943, California 5332921, 92093
Status
Address
Southern California Kaiser Permanente
Los Angeles 5368361, California 5332921, 90027
Status
Address
University of Southern California Medical Center
Los Angeles 5368361, California 5332921, 90032
Status
Address
Univ Of California Irvine College Of Medicine
Orange 5379513, California 5332921, 92868
Status
Address
UCSF Mount Zion Medical Ctr
San Francisco 5391959, California 5332921, 94115
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Address
UCSF Mission Bay
San Francisco 5391959, California 5332921, 94158
Status
Address
Sarcoma Oncology Center
Santa Monica 5393212, California 5332921, 90403
Status
Address
Sarcoma Oncology Research Center LLC
Santa Monica 5393212, California 5332921, 90403
Status
Address
University of Colorado Cancer Center
Aurora 5412347, Colorado 5417618, 80045
Status
Address
Yale University
New Haven 4839366, Connecticut 4831725, 6519
Status
Address
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C. 4140963, District of Columbia 4138106, 20007
Status
Address
Florida Cancer Specialists - Sarasota
Sarasota 4172131, Florida 4155751, 34232
Status
Address
H. Lee Moffitt Cancer Center and Research Inst.
Tampa 4174757, Florida 4155751, 33612-9497
Status
Address
University Cancer & Blood Center, LLC
Athens 4180386, Georgia 4197000, 30607
Status
Address
Winship Cancer Institute
Atlanta 4180439, Georgia 4197000, 30322
Status
Address
Southeastern Regional Medical Center, Inc.
Newnan 4212684, Georgia 4197000, 30265
Status
Address
Northwestern University
Chicago 4887398, Illinois 4896861, 60611
Status
Address
Advocate Medical Group - Park Ridge, Luther Lane - Oncology
Park Ridge 4905367, Illinois 4896861, 60068
Status
Address
Midwestern Regional Medical Center
Zion 4917358, Illinois 4896861, 60099
Status
Address
Weinberg Cancer Institution at Franklin Square
Baltimore 4347778, Maryland 4361885, 21237
Status
Address
Massachusetts General Hosp CAR
Boston 4930956, Massachusetts 6254926, 02114
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Address
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926, 02114
Status
Address
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926, 02215
Status
Address
Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926, 02215
Status
Address
University of Michigan Comprehensive Cancer Center
Ann Arbor 4984247, Michigan 5001836, 48109
Status
Address
Karmanos Cancer Center
Detroit 4990729, Michigan 5001836, 48201
Status
Address
Henry Ford Hospital
Detroit 4990729, Michigan 5001836, 48202
Status
Address
Regents of the University of Minnesota
Minneapolis 5037649, Minnesota 5037779, 55455
Status
Address
Washington University
St Louis 4407066, Missouri 4398678, 63128
Status
Address
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas 5506956, Nevada 5509151, 89169
Status
Address
North Shore Hem Onc Associates
East Setauket 5116060, New York 5128638, 11733
Status
Address
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638, 10022
Status
Address
Levine Cancer Institute
Charlotte 4460243, North Carolina 4482348, 28204
Status
Address
Duke Cancer Institute
Durham 4464368, North Carolina 4482348, 27710
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Address
Ohio State University
Columbus 4509177, Ohio 5165418, 43210
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Address
OSU, James Cancer Hospital
Columbus 4509177, Ohio 5165418, 43210
Status
Address
Cancer Treatment Centers of America
Tulsa 4553433, Oklahoma 4544379, 74133
Status
Address
Oregon Health & Science University
Portland 5746545, Oregon 5744337, 97239-3098
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Address
Oregon Health & Science Univ
Portland 5746545, Oregon 5744337, 97239
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Address
Mary Crowley Medical Research Center
Dallas 4684888, Texas 4736286, 75230
Status
Address
University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286, 77030
Status
Address
Baylor Scott & White Health
Temple 4735966, Texas 4736286, 76508
Status
Address
University of Utah Hospitals & Clinics
Salt Lake City 5780993, Utah 5549030, 84112
Status
Address
Virginia Cancer Specialists, PC
Fairfax 4758023, Virginia 6254928, 22031
Status
Address
Virginia Oncology Associates - Hampton
Norfolk 4776222, Virginia 6254928, 23502
Status
Address
University of Washington Seattle Cancer Care Alliance
Seattle 5809844, Washington 5815135, 98109
International Sites
Status
Address
Liverpool Hospital
Liverpool 2159851, New South Wales 2155400, 2170
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Address
Newcastle Private Hospital
Newcastle 2155472, New South Wales 2155400, 2305
Status
Address
Flinders Medical Centre
Bedford Park 2076918, South Australia 2061327, 5042
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Address
Austin Health
Heidelberg 2163654, Victoria 2145234, 3084
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Address
Antwerp University Hospital
Edegem 2799007, , 2650
Status
Address
Beijing Cancer Hospital
Beijing 1816670, , 100142
Status
Address
Sichuan Provincial Cancer Hospital
Chengdu 1815286, , 610041
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Address
Cancer Center of Guangzhou Medical University
Guangzhou 1809858, , 510000
Status
Address
Zhejiang Cancer Hospital
Hangzhou 1808926, , 310022
Status
Address
Harbin Medical University Cancer Hospital
Harbin 2037013, , 150081
Status
Address
Shanghai chest hospital
Shanghai 1796236, , 200030
Status
Address
Fudan University Shanghai Cancer Center
Shanghai 1796236, , 200120
Status
Address
Shenzhen People's Hospital
Shenzhen 1795565, , 510852
Status
Address
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan 1791247, , 430023
Status
Address
Institut de Cancerologie de l Ouest
Angers 3037656, , 49055
Status
Address
Institut Bergonie
Bordeaux 3031582, , 33076
Status
Address
Centre Leon Berard
Lyon 2996944, , 69373
Status
Address
Hôpital de la Timone
Marseille 2995469, , 13385
Status
Address
Hôpital Nord - AP-HM Marseille#
Marseille 2995469, , 13915
Status
Address
Institut de Recherche en Cancérologie de Montpellier
Montpellier 2992166, , 34090
Status
Address
Institut Curie
Paris 2988507, , 75005
Status
Address
Institut De Cancerologie De L'ouest - Rene Gauducheau - Biology
Saint-Herblain 2979590, , 44805
Status
Address
Institut Claudius Regaud
Toulouse 2972315, , 31059
Status
Address
Institut Gustave Roussy
Villejuif 2968705, , 94805
Status
Address
Evang. Lungenklinik Berlin Klinik für Pneumologie
Berlin 2950159, , 13125
Status
Address
Universitaetsklinikum Koeln
Cologne 2886242, , 50937
Status
Address
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden 2935022, , 01307
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Address
Universitaetsmedizin Goettingen
Göttingen 2918632, , 37075
Status
Address
NCT Uniklinikum Heidelberg
Heidelberg 2907911, , 69120
Status
Address
Princess Margaret Hospital
Hong Kong 1819729, ,
Status
Address
The University of Hong Kong
Hong Kong 1819729, ,
Status
Address
Queen Elizabeth Hospital
Kowloon 1819609, ,
Status
Address
The Chinese University of Hong Kong
Shatin 1818920, , 123456
Status
Address
Seconda Università degli Studi di Napoli
Napoli 9031661, Campania 3181042, 80131
Status
Address
Università Campus Bio-Medico di Roma
Rome 3169070, Lazio 3174976, 128
Status
Address
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan 3173435, Lombardy 3174618, 20133
Status
Address
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
Milan 3173435, Lombardy 3174618, 20162
Status
Address
Azienda Ospedaliero Universitaria Pisana
Pisa 3170647, Tuscany 3165361, 56126
Status
Address
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia 3171180, Umbria 3165048, 6132
Status
Address
IOV - Istituto Oncologico Veneto - IRCCS
Padua 3171728, Veneto 3164604, 35128
Status
Address
Aichi Cancer Center Hospital
Aichi 11192139, , 464-8681
Status
Address
National Cancer Center Hospital
Chūō 13353695, , 104-0045
Status
Address
NHO Kyushu Cancer Center
Fukuoka 1863967, , 811-1395
Status
Address
Hyogo Cancer Center, Dept of Respiratory Medicine
Hyōgo 2129969, , 673-8558
Status
Address
National Cancer Center Hospital
Kashiwa-shi, , 277-8577
Status
Address
NHO Shikoku Cancer Center
Matsuyama 1926099, , 791-0280
Status
Address
Miyagi Cancer Center
Miyagi 1856813, , 981-1293
Status
Address
Niigata Cancer Center Hospital
Niigata 1855431, , 951-8566
Status
Address
Osaka City General Hospital
Osaka 1853909, , 534-0021
Status
Address
Kindai University Hospital
Osaka 1853909, , 589-8511
Status
Address
Shizuoka Cancer Center
Shizuoka 1851717, , 411-8777
Status
Address
NKI The Netherlands Cancer Institute
Amsterdam 2759794, , 1066 CX
Status
Address
Leids Universitair Medisch Centrum
Leiden 2751773, , 2333 ZA
Status
Address
Uniwersyteckie Centrum Kliniczne
Gdansk 3099434, , 80-214
Status
Address
Centrum Onkologii-Instytut im.M.Sklodowskiej Curie
Gliwice 3099230, , 44-101
Status
Address
Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego
Późna 7534652, , 60-569
Status
Address
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
Warsaw 756135, , 02-781
Status
Address
National University Hospital
Singapore 1880252, , 119228
Status
Address
National Cancer Centre
Singapore 1880252, , 169610
Status
Address
Seoul National University Hospital
Seoul 1835848, , 03080
Status
Address
Asan Medical Center.
Seoul 1835848, , 05505
Status
Address
Samsung Medical Center
Seoul 1835848, , 06351
Status
Address
Severance Hospital, Yonsei University Health System
Seoul 1835848, , 120-752
Status
Address
Centro Nacional de Investigaciones Oncológicas(CNIO)
Fuenlabrada 3121960, Madrid 3117732, 28942
Status
Address
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona 3128760, , 08035
Status
Address
Hospital Universitario Ramon y Cajal
Madrid 3117735, , 28034
Status
Address
Hospital Universitario Clínico San Carlos
Madrid 3117735, , 28040
Status
Address
Hospital Universitario 12 de Octubre
Madrid 3117735, , 28041
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Address
Hospital Universitario La Paz
Madrid 3117735, , 28046
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Address
Hospital Clinico Universitario Virgen de la Victoria
Málaga 2514256, , 29010
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Address
Hospital Universitario Virgen del Rocio
Seville 2510911, , 41013
Status
Address
National Cheng Kung University Hospital
Tainan City 1668355, , 70457
Status
Address
National Taiwan University Hospital
Taipei 1668341, , 00100
Status
Address
Taipei Veterans General Hospital
Taipei 1668341, , 11217
Status
Address
Addenbrookes Hospital
Cambridge 2653941, , CB2 0QQ
Status
Address
Sarah Cannon Research Institute
London 2643743, , W1G 6AD
Status
Address
The Christie
Manchester 2643123, , M20 4BX
