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)

  • Cancer
  • Renal Cell Cancer (RCC)
  • Pancreatic Cancer
  • Solid Tumors
  • Skin Cancer
  • Malignant Melanoma
  • Renal Cell Carcinoma
  • Sarcoma
  • Non Hodgkin Lymphoma (NHL)
  • Lymphoma
  • Colorectal Cancer (CRC)
  • Lung Cancer
  • Non Small Cell Lung Carcinoma
  • Ovarian Cancer
  • Breast Cancer
  • Thyroid Cancer
  • Melanoma
  • Head and Neck Cancer
  • Head and Neck Neoplasms
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Active, not recruiting

This study runs in
Cities
  • Aichi
  • Amsterdam
  • Angers
  • Ann Arbor
  • Aurora
  • Baltimore
  • Barcelona
  • Bedford Park
  • Beijing
  • Berlin
  • Bordeaux
  • Boston
  • Cambridge
  • Charlotte
  • Chengdu
  • Chicago
  • chuo
  • Columbus
  • Dallas
  • Dresden
  • Duarte
  • Edegem
  • Fairfax
  • Fuenlabrada
  • Fukuoka
  • Gdansk
  • Gliwice
  • Guangzhou
  • Göttingen
  • Hangzhou
  • Harbin
  • Heidelberg
  • Hong Kong
  • Houston
  • Hyogo
  • Kashiwa-shi
  • Köln
  • La Jolla
  • Leiden
  • Liverpool
  • London
  • Los Angeles
  • Lyon
  • Madrid
  • Manchester
  • Marseille cedex 20
  • Marseille cedex 5
  • matsuyama-shi
  • Milano
  • Minneapolis
  • Miyagi
  • Montpellier
  • Málaga
  • Napoli
  • New York
  • newcastle
  • Niigata
  • Norfolk
  • Osaka
  • Padova
  • Paris
  • Perugia
  • Phoenix
  • Pisa
  • Portland
  • pozna-
  • Roma
  • Saint-Herblain
  • Salt Lake City
  • San Francisco
  • Santa Monica
  • Sarasota
  • Seattle
  • Seoul
  • Sevilla
  • Shanghai
  • Shatin
  • Shenzhen
  • Shizuoka
  • Singapore
  • Tainan City
  • Taipei City
  • Tampa
  • Temple
  • Toronto
  • Toulouse
  • VILLEJUIF Cedex
  • Warszawa
  • Washington
  • Wuhan City
  • Zion
Trial Identifier:

NCT02568267 2015-003385-84 GO40782 RXDX-101-02

  • Addenbrookes Hospital

    CB2 0QQCambridgeUnited Kingdom
  • Aichi Cancer Center Hospital

    464-8681AichiJapan
  • Antwerp University Hospital

    655 Drie Eikenstraat2650EdegemBelgium
  • Asan Medical Center.

    05505SeoulKorea, Republic of
  • Austin Health

    145 Studley Rd3084HeidelbergAustralia
  • Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

    3 Piazzale Giorgio Menghini6132PerugiaItaly
  • Azienda Ospedaliero Universitaria Pisana

    56126PisaItaly
  • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

    3 Piazza dell'Ospedale Maggiore20162MilanoItaly
  • Baylor Scott & White Health

    1901 SW H K Dodgen Loop76508TempleUnited States
  • Beijing Cancer Hospital

    52 Fu Cheng Lu100142BeijingChina
  • Beth Israel Deaconess Medical Center

    330 Brookline Ave02215BostonUnited States
  • Cancer Center of Guangzhou Medical University

    195号 Dong Feng Xi Lu510000GuangzhouChina
  • Centre Leon Berard

    69373LyonFrance
  • Centro Nacional de Investigaciones Oncológicas(CNIO)

    3 C. de Melchor Fernández Almagro28942FuenlabradaSpain
  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

    15 Wawelska02-781WarszawaPoland
  • Centrum Onkologii-Instytut im.M.Sklodowskiej Curie

    44-101GliwicePoland
  • City of Hope Cancer Center

    1500 E Duarte Rd91010DuarteUnited States
  • Dana Farber Cancer Institute

    02215BostonUnited States
  • Dignity Health St Joseph's Hospital and Medical Center

    350 W Thomas Rd85013PhoenixUnited States
  • Evang. Lungenklinik Berlin Klinik für Pneumologie

    27 Lindenberger Weg13125BerlinGermany
  • Flinders Medical Centre

    5042Bedford ParkAustralia
  • Florida Cancer Specialists - Sarasota

    600 N Cattlemen Rd34232SarasotaUnited States
  • Fondazione IRCCS Istituto Nazionale dei Tumori

    1 Via Giacomo Venezian20133MilanoItaly
  • Fudan University Shanghai Cancer Center

    270号 Dong An Lu200120ShanghaiChina
  • Georgetown University Medical Center Lombardi Cancer Center

    3800 Reservoir Rd NW20007WashingtonUnited States
  • H. Lee Moffitt Cancer Center and Research Inst.

    33612-9497TampaUnited States
  • Harbin Medical University Cancer Hospital

    150081HarbinChina
  • Hôpital de la Timone

    264 Rue Saint-Pierre13385Marseille cedex 5France
  • Hôpital Nord - AP-HM Marseille#

    13915Marseille cedex 20France
  • Hospital Clinico Universitario Virgen de la Victoria

    S/N Campus de Teatinos29010MálagaSpain
  • Hospital Universitario 12 de Octubre

    s/n Av. de Córdoba28041MadridSpain
  • Hospital Universitario Clínico San Carlos

    S/N Calle del Prof Martín Lagos28040MadridSpain
  • Hospital Universitario Ramon y Cajal

    Km. 9 M-60728034MadridSpain
  • Hospital Universitario Virgen del Rocio

    S/n Av. Manuel Siurot41013SevillaSpain
  • Hyogo Cancer Center, Dept of Respiratory Medicine

    673-8558HyogoJapan
  • Institut Bergonie

    33076BordeauxFrance
  • Institut Claudius Regaud

    31059ToulouseFrance
  • Institut Curie

    26 Rue d'Ulm75005ParisFrance
  • Institut de Cancerologie de l Ouest

    15 Rue André Boquel49055AngersFrance
  • Institut De Cancerologie De L'ouest - Rene Gauducheau - Biology

    44805Saint-HerblainFrance
  • Institut de Recherche en Cancérologie de Montpellier

    34090MontpellierFrance
  • Institut Gustave Roussy

    94805VILLEJUIF CedexFrance
  • IOV - Istituto Oncologico Veneto - IRCCS

    64 Via Gattamelata35128PadovaItaly
  • Kindai University Hospital

    589-8511OsakaJapan
  • Leids Universitair Medisch Centrum

    2 Albinusdreef2333 ZALeidenNetherlands
  • Levine Cancer Institute

    1021 Morehead Medical Dr28204CharlotteUnited States
  • Liverpool Hospital

    2170LiverpoolAustralia
  • Mary Crowley Medical Research Center

    7777 Forest Ln75230DallasUnited States
  • Massachusetts General Hospital

    55 Fruit St02114BostonUnited States
  • Mayo Clinic

    5777 E Mayo Blvd85054PhoenixUnited States
  • Memorial Sloan Kettering Cancer Center

    10022New YorkUnited States
  • Midwestern Regional Medical Center

    2520 Elisha Ave60099ZionUnited States
  • Miyagi Cancer Center

    981-1293MiyagiJapan
  • National Cancer Center Hospital

    104-0045chuoJapan
  • National Cancer Center Hospital

    277-8577Kashiwa-shiJapan
  • National Cancer Centre

    30 Hospital Boulevard169610SingaporeSingapore
  • National Cheng Kung University Hospital

    138號 Shengli Rd70457Tainan CityTaiwan
  • National Taiwan University Hospital

    00100Taipei CityTaiwan
  • National University Hospital

    5 Lower Kent Ridge Rd119228SingaporeSingapore
  • NCT Uniklinikum Heidelberg

    672 Im Neuenheimer Feld69120HeidelbergGermany
  • Newcastle Private Hospital

    14 Lookout Rd2305newcastleAustralia
  • NHO Kyushu Cancer Center

    811-1395FukuokaJapan
  • NHO Shikoku Cancer Center

    791-0280matsuyama-shiJapan
  • Niigata Cancer Center Hospital

    951-8566NiigataJapan
  • NKI The Netherlands Cancer Institute

    121 Plesmanlaan1066 CXAmsterdamNetherlands
  • Northwestern University

    300 E Superior St60611ChicagoUnited States
  • Ohio State University

    281 W Lane Ave43210ColumbusUnited States
  • Oregon Health & Science University

    3181 SW Sam Jackson Park Rd97239-3098PortlandUnited States
  • Osaka City General Hospital

    534-0021OsakaJapan
  • OSU, James Cancer Hospital

    460 W 10th Ave43210ColumbusUnited States
  • Princess Margaret Hospital

    2-10 Princess Margaret Hospital RdHong KongHong Kong
  • Queen Elizabeth Hospital

    30號 Gascoigne RdTorontoHong Kong
  • Regents of the University of Minnesota

    55455MinneapolisUnited States
  • Samsung Medical Center

    06351SeoulKorea, Republic of
  • Sarah Cannon Research Institute

    1 Capper StW1G 6ADLondonUnited Kingdom
  • Sarcoma Oncology Center

    2811 Wilshire Blvd90403Santa MonicaUnited States
  • Sarcoma Oncology Research Center LLC

    2811 Wilshire Blvd90403Santa MonicaUnited States
  • Seconda Università degli Studi di Napoli

    2 Piazza Luigi Miraglia80131NapoliItaly
  • Severance Hospital, Yonsei University Health System

    120-752SeoulKorea, Republic of
  • Shanghai chest hospital

    200030ShanghaiChina
  • Shenzhen People's Hospital

    510852ShenzhenChina
  • Shizuoka Cancer Center

    411-8777ShizuokaJapan
  • Sichuan Provincial Cancer Hospital

    610041ChengduChina
  • Southern California Kaiser Permanente

    4867 W Sunset Blvd90027Los AngelesUnited States
  • Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego

    1 Długa60-569pozna-Poland
  • Taipei Veterans General Hospital

    201號 Section 2, Shipai Rd11217Taipei CityTaiwan
  • The Chinese University of Hong Kong

    123456ShatinHong Kong
  • The Christie

    M20 4BXManchesterUnited Kingdom
  • The University of Hong Kong

    Hong KongHong Kong
  • UCSF Mount Zion Medical Ctr

    94115San FranciscoUnited States
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    430023Wuhan CityChina
  • Università Campus Bio-Medico di Roma

    21 Via Álvaro del Portillo128RomaItaly
  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    74 Fetscherstraße01307DresdenGermany
  • Universitaetsklinikum Koeln

    62 Kerpener Str.50937KölnGermany
  • Universitaetsmedizin Goettingen

    37075GöttingenGermany
  • University of California San Diego Moores Cancer Center

    3855 Health Sciences Dr92093La JollaUnited States
  • University of Colorado Cancer Center

    80045AuroraUnited States
  • University of Michigan Comprehensive Cancer Center

    1754 E Medical Center Dr48109Ann ArborUnited States
  • University of Southern California Medical Center

    1200 N State St90032Los AngelesUnited States
  • University of Texas MD Anderson Cancer Center

    1515 Holcombe Blvd77030HoustonUnited States
  • University of Utah Hospitals & Clinics

    3730 4700 S84112Salt Lake CityUnited States
  • University of Washington Seattle Cancer Care Alliance

    820 Yale Ave N98109SeattleUnited States
  • Uniwersyteckie Centrum Kliniczne

    7 Dębinki80-214GdanskPoland
  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    08035BarcelonaSpain
  • Virginia Cancer Specialists, PC

    22031FairfaxUnited States
  • Virginia Oncology Associates - Hampton

    3000 Coliseum Dr23502NorfolkUnited States
  • Weinberg Cancer Institution at Franklin Square

    21237BaltimoreUnited States
  • Zhejiang Cancer Hospital

    310022HangzhouChina
    Show study locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Study Summary

    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.

    Hoffmann-La Roche Sponsor
    Phase 2 Phase
    NCT02568267, RXDX-101-02, 2015-003385-84,GO40782 Trial Identifier
    Entrectinib Treatments
    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 Condition
    Official Title

    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

    Eligibility Criteria

    All Gender
    ≥18 Years Age
    No Healthy Volunteers
    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. 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
    • 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
    • Other protocol specified criteria

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