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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, Korea, Republic of, Netherlands, Poland, Singapore, 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, Arizona, 85013
Status
Address
Mayo Clinic
Phoenix, Arizona, 85054
Status
Address
City of Hope Cancer Center
Duarte, California, 91010
Status
Address
City of Hope Duarte - Comprehensive Cancer Center, Investigational Drug Services
Duarte, California, 91010
Status
Address
Scripps Clinic
La Jolla, California, 92037
Status
Address
University of California San Diego Moores Cancer Center
La Jolla, California, 92093
Status
Address
Southern California Kaiser Permanente
Los Angeles, California, 90027
Status
Address
University of Southern California Medical Center
Los Angeles, California, 90032
Status
Address
Univ Of California Irvine College Of Medicine
Orange, California, 92868
Status
Address
UCSF Mount Zion Medical Ctr
San Francisco, California, 94115
Status
Address
UCSF Mission Bay
San Francisco, California, 94158
Status
Address
Sarcoma Oncology Center
Santa Monica, California, 90403
Status
Address
Sarcoma Oncology Research Center LLC
Santa Monica, California, 90403
Status
Address
University of Colorado Cancer Center
Aurora, Colorado, 80045
Status
Address
Yale University
New Haven, Connecticut, 6519
Status
Address
Georgetown University Medical Center Lombardi Cancer Center
Washington, District of Columbia, 20007
Status
Address
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232
Status
Address
H. Lee Moffitt Cancer Center and Research Inst.
Tampa, Florida, 33612-9497
Status
Address
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
Status
Address
Winship Cancer Institute
Atlanta, Georgia, 30322
Status
Address
Southeastern Regional Medical Center, Inc.
Newnan, Georgia, 30265
Status
Address
Northwestern University
Chicago, Illinois, 60611
Status
Address
Advocate Medical Group - Park Ridge, Luther Lane - Oncology
Park Ridge, Illinois, 60068
Status
Address
Midwestern Regional Medical Center
Zion, Illinois, 60099
Status
Address
Weinberg Cancer Institution at Franklin Square
Baltimore, Maryland, 21237
Status
Address
Massachusetts General Hosp CAR
Boston, Massachusetts, 02114
Status
Address
Massachusetts General Hospital
Boston, Massachusetts, 02114
Status
Address
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Status
Address
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Status
Address
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Status
Address
Karmanos Cancer Center
Detroit, Michigan, 48201
Status
Address
Henry Ford Hospital
Detroit, Michigan, 48202
Status
Address
Regents of the University of Minnesota
Minneapolis, Minnesota, 55455
Status
Address
Washington University
Saint Louis, Missouri, 63128
Status
Address
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, 89169
Status
Address
North Shore Hem Onc Associates
East Setauket, New York, 11733
Status
Address
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
Status
Address
Levine Cancer Institute
Charlotte, North Carolina, 28204
Status
Address
Duke Cancer Institute
Durham, North Carolina, 27710
Status
Address
Ohio State University
Columbus, Ohio, 43210
Status
Address
OSU, James Cancer Hospital
Columbus, Ohio, 43210
Status
Address
Cancer Treatment Centers of America
Tulsa, Oklahoma, 74133
Status
Address
Oregon Health & Science University
Portland, Oregon, 97239-3098
Status
Address
Oregon Health & Science Univ
Portland, Oregon, 97239
Status
Address
Mary Crowley Medical Research Center
Dallas, Texas, 75230
Status
Address
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Status
Address
Baylor Scott & White Health
Temple, Texas, 76508
Status
Address
University of Utah Hospitals & Clinics
Salt Lake City, Utah, 84112
Status
Address
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Status
Address
Virginia Oncology Associates - Hampton
Norfolk, Virginia, 23502
Status
Address
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, 98109
International Sites
Status
Address
Liverpool Hospital
Liverpool, New South Wales, 2170
Status
Address
Newcastle Private Hospital
Newcastle, New South Wales, 2305
Status
Address
Flinders Medical Centre
Bedford Park, South Australia, 5042
Status
Address
Austin Health
Heidelberg, Victoria, 3084
Status
Address
Antwerp University Hospital
Edegem, , 2650
Status
Address
Beijing Cancer Hospital
Beijing, , 100142
Status
Address
Sichuan Provincial Cancer Hospital
Chengdu, , 610041
Status
Address
Cancer Center of Guangzhou Medical University
Guangzhou, , 510000
Status
Address
Zhejiang Cancer Hospital
Hangzhou, , 310022
Status
Address
Harbin Medical University Cancer Hospital
Harbin, , 150081
Status
Address
Shanghai chest hospital
Shanghai, , 200030
Status
Address
Fudan University Shanghai Cancer Center
Shanghai, , 200120
Status
Address
Shenzhen People's Hospital
Shenzhen, , 510852
Status
Address
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan City, , 430023
Status
Address
Institut de Cancerologie de l Ouest
Angers, , 49055
Status
Address
Institut Bergonie
Bordeaux, , 33076
Status
Address
Centre Leon Berard
Lyon, , 69373
Status
Address
Hôpital Nord - AP-HM Marseille#
Marseille cedex 20, , 13915
Status
Address
Hôpital de la Timone
Marseille cedex 5, , 13385
Status
Address
Institut de Recherche en Cancérologie de Montpellier
Montpellier, , 34090
Status
Address
Institut Curie
Paris, , 75005
Status
Address
Institut De Cancerologie De L'ouest - Rene Gauducheau - Biology
Saint Herblain, , 44805
Status
Address
Institut Claudius Regaud
Toulouse, , 31059
Status
Address
Institut Gustave Roussy
Villejuif cedex, , 94805
Status
Address
Evang. Lungenklinik Berlin Klinik für Pneumologie
Berlin, , 13125
Status
Address
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, , 01307
Status
Address
Universitaetsmedizin Goettingen
Göttingen, , 37075
Status
Address
NCT Uniklinikum Heidelberg
Heidelberg, , 69120
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Address
Universitaetsklinikum Koeln
Köln, , 50937
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Address
Princess Margaret Hospital
Hong Kong, ,
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Address
The University of Hong Kong
Hong Kong, ,
Status
Address
Queen Elizabeth Hospital
Kowloon, ,
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Address
The Chinese University of Hong Kong
Shatin, , 123456
Status
Address
Seconda Università degli Studi di Napoli
Napoli, Campania, 80131
Status
Address
Università Campus Bio-Medico di Roma
Roma, Lazio, 128
Status
Address
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Lombardia, 20133
Status
Address
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
Milano, Lombardia, 20162
Status
Address
Azienda Ospedaliero Universitaria Pisana
Pisa, Toscana, 56126
Status
Address
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia, Umbria, 6132
Status
Address
IOV - Istituto Oncologico Veneto - IRCCS
Padova, Veneto, 35128
Status
Address
Aichi Cancer Center Hospital
Aichi, , 464-8681
Status
Address
National Cancer Center Hospital
Chuo, , 104-0045
Status
Address
NHO Kyushu Cancer Center
Fukuoka, , 811-1395
Status
Address
Hyogo Cancer Center, Dept of Respiratory Medicine
Hyogo, , 673-8558
Status
Address
National Cancer Center Hospital
Kashiwa-shi, , 277-8577
Status
Address
NHO Shikoku Cancer Center
Matsuyama-shi, , 791-0280
Status
Address
Miyagi Cancer Center
Miyagi, , 981-1293
Status
Address
Niigata Cancer Center Hospital
Niigata, , 951-8566
Status
Address
Osaka City General Hospital
Osaka, , 534-0021
Status
Address
Kindai University Hospital
Osaka, , 589-8511
Status
Address
Shizuoka Cancer Center
Shizuoka, , 411-8777
Status
Address
Seoul National University Hospital
Seoul, , 03080
Status
Address
Asan Medical Center.
Seoul, , 05505
Status
Address
Samsung Medical Center
Seoul, , 06351
Status
Address
Severance Hospital, Yonsei University Health System
Seoul, , 120-752
Status
Address
NKI The Netherlands Cancer Institute
Amsterdam, , 1066 CX
Status
Address
Leids Universitair Medisch Centrum
Leiden, , 2333 ZA
Status
Address
Uniwersyteckie Centrum Kliniczne
Gdansk, , 80-214
Status
Address
Centrum Onkologii-Instytut im.M.Sklodowskiej Curie
Gliwice, , 44-101
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Address
Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego
Pozna?, , 60-569
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Address
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
Warszawa, , 02-781
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Address
National University Hospital
Singapore, , 119228
Status
Address
National Cancer Centre
Singapore, , 169610
Status
Address
Centro Nacional de Investigaciones Oncológicas(CNIO)
Fuenlabrada, Madrid, 28942
Status
Address
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, , 08035
Status
Address
Hospital Universitario Ramon y Cajal
Madrid, , 28034
Status
Address
Hospital Universitario Clínico San Carlos
Madrid, , 28040
Status
Address
Hospital Universitario 12 de Octubre
Madrid, , 28041
Status
Address
Hospital Universitario La Paz
Madrid, , 28046
Status
Address
Hospital Clinico Universitario Virgen de la Victoria
Malaga, , 29010
Status
Address
Hospital Universitario Virgen del Rocio
Sevilla, , 41013
Status
Address
National Cheng Kung University Hospital
Tainan, , 70457
Status
Address
National Taiwan University Hospital
Taipei, , 00100
Status
Address
Taipei Veterans General Hospital
Taipei, , 11217
Status
Address
Addenbrookes Hospital
Cambridge, , CB2 0QQ
Status
Address
Sarah Cannon Research Institute
London, , W1G 6AD
Status
Address
The Christie
Manchester, , M20 4BX
