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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) (STARTRK-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568267
Recruitment Status : Recruiting
First Posted : October 5, 2015
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
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 Drug: Entrectinib Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 19, 2015
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 2, 2024


Arm Intervention/treatment
Experimental: NTRK1/2/3-rearranged NSCLC
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101

Experimental: ROS1-rearranged NSCLC
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: 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)

Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101

Experimental: NTRK/1/2/3-rearranged mCRC
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101

Experimental: ROS1-rearranged mCRC
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101

Experimental: ALK-rearranged mCRC
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101

Experimental: NTRK1/2/3-rearranged other solid tumor
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101

Experimental: ROS1-rearranged other solid tumor
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101

Experimental: ALK-rearranged other solid tumor
Oral entrectinib (RXDX-101)
Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Name: RXDX-101




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RECIST v1.1


Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RECIST v1.1

  2. Time to Response [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RECIST v1.1

  3. Clinical Benefit Rate [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RECIST v1.1

  4. Intracranial Tumor Response [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable

  5. CNS Progression-free Survival [ Time Frame: Approximately 24 months ]
    Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable

  6. Progression-free Survival [ Time Frame: Approximately 30 months ]
    Assessed by Kaplan-Meier method

  7. Overall Survival [ Time Frame: Approximately 36 months ]
    Assessed by Kaplan-Meier method

  8. Population PK [ Time Frame: Approximately 24 months ]
    Assessed by Kaplan-Meier method

  9. Adverse Events [ Time Frame: Approximately 36 months ]
    Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, graded by the NCI CTCAE

  10. Quality of Life [ Time Frame: Approximately 24 months ]
    Assessed with the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and the Euro-QoL Group EQ-5D. NSCLC and mCRC patients will complete the lung cancer and colorectal cancer specific modules, QLQ-LC13 and QLQ-CR29, respectively

  11. Bone Growth and Bone Mineral Density [ Time Frame: Approximately 30 months ]
    Assessed with DHA scans

  12. Bone Biomarkers [ Time Frame: Approximately 30 months ]
    Measured by blood



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, bone metabolism alterations or osteopenia
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568267


Contacts
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Contact: Reference Study ID Number: GO40782 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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United States, Arizona
Western Regional Medical Center at Cancer Treatment Centers of America Withdrawn
Goodyear, Arizona, United States, 85338
Dignity Health St Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Mayo Clinic Active, not recruiting
Scottsdale, Arizona, United States, 85259
United States, California
City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics Recruiting
Duarte, California, United States, 91010
Scripps Clinic Active, not recruiting
La Jolla, California, United States, 92037
University of California San Diego Moores Cancer Center; Dept of Lung Cancer Recruiting
La Jolla, California, United States, 92093
University of Southern California Medical Center Recruiting
Los Angeles, California, United States, 90033
Univ Of California Irvine College Of Medicine; 300194620 Active, not recruiting
Orange, California, United States, 92868
Southern California Kaiser Permanente Recruiting
San Diego, California, United States, 92108
UCSF Mount Zion Medical Ctr Active, not recruiting
San Francisco, California, United States, 94115
Sarcoma Oncology Center Recruiting
Santa Monica, California, United States, 90403
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University Active, not recruiting
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown University Medical Center Lombardi Cancer Center Active, not recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Florida Cancer Specialists - Sarasota Active, not recruiting
Sarasota, Florida, United States, 34232
H. Lee Moffitt Cancer Center and Research Inst. Recruiting
Tampa, Florida, United States, 33612
Cleveland Clinic Florida Withdrawn
Weston, Florida, United States, 33331
United States, Georgia
University Cancer & Blood Center, LLC; Research Active, not recruiting
Athens, Georgia, United States, 30607
Winship Cancer Institute Active, not recruiting
Atlanta, Georgia, United States, 30322
Southeastern Regional Medical Center, Inc. Completed
Newnan, Georgia, United States, 30265
United States, Hawaii
University of Hawaii Cancer Center Withdrawn
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwestern University Active, not recruiting
Chicago, Illinois, United States, 60611
Advocate Medical Group - Park Ridge, Luther Lane - Oncology Completed
Park Ridge, Illinois, United States, 60068
Midwestern Regional Medical Center Recruiting
Zion, Illinois, United States, 60099
United States, Maryland
Weinberg Cancer Institution at Franklin Square Recruiting
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Comprehensive Cancer Center Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Center Active, not recruiting
Detroit, Michigan, United States, 48201
Henry Ford Hospital Active, not recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
Regents of the University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University Active, not recruiting
Saint Louis, Missouri, United States, 63128
United States, Nevada
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley Recruiting
Las Vegas, Nevada, United States, 89169
United States, New Hampshire
Dartmouth Hitchcock Medical Center Withdrawn
Lebanon, New Hampshire, United States, 03756
United States, New York
North Shore Hem Onc Associates Active, not recruiting
East Setauket, New York, United States, 11733
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Duke Cancer Institute Active, not recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Withdrawn
Cleveland, Ohio, United States, 44195
OSU, James Cancer Hospital Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Cancer Treatment Centers of America; Tulsa Active, not recruiting
Tulsa, Oklahoma, United States, 74133
United States, Oregon
Providence Portland Medical Center Withdrawn
Portland, Oregon, United States, 97213
Oregon Health & Science Univ Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Cancer Treatment Centers of America - Eastern Regional Medical Center Completed
Philadelphia, Pennsylvania, United States, 19124
United States, Texas
Mary Crowley Medical Research Center Recruiting
Dallas, Texas, United States, 75230
University Hospital Medical Oncology Clinic; Harold C. Simmons Comprehensive Cancer Center Withdrawn
Dallas, Texas, United States, 75390
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Baylor Scott & White Health Recruiting
Temple, Texas, United States, 76502
United States, Utah
University of Utah Hospitals & Clinics Recruiting
Salt Lake City, Utah, United States, 84132
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Virginia Oncology Associates - Hampton Recruiting
Hampton, Virginia, United States, 23666
United States, Washington
University of Washington Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98195
United States, Wisconsin
Wheaton Franciscan Cancer Care-All Saints Withdrawn
Franklin, Wisconsin, United States, 53132
Australia, New South Wales
Border Medical Oncology Research Unit Withdrawn
Albury, New South Wales, Australia, 2640
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
Newcastle Private Hospital Active, not recruiting
New Lambton Heights, New South Wales, Australia, 2305
Australia, South Australia
Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Austin Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Belgium
Antwerp University Hospital Recruiting
Edegem, Belgium, 2650
China
Beijing Cancer Hospital Not yet recruiting
Beijing, China, 100142
Beijing Union Hospital Not yet recruiting
Beijing, China, 100730
Hunan Cancer Hospital Not yet recruiting
Changsha City, China, 410013
Sichuan Provincial Cancer Hospital Recruiting
Chengdu, China, 610041
Fujian Provincial Cancer Hospital Not yet recruiting
Fuzhou City, China, 350014
Cancer Center of Guangzhou Medical University Not yet recruiting
Guangzhou, China, 510000
Harbin Medical University Cancer Hospital Recruiting
Harbin, China, 150081
Fudan University Shanghai Cancer Center Recruiting
Shanghai City, China, 200120
Shanghai chest hospital Recruiting
Shanghai, China, 200030
Shenzhen People's Hospital Not yet recruiting
Shenzhen, China, 510852
Tianjin Cancer Hospital Not yet recruiting
Tianjin, China, 300060
Union Hospital Tongji Medical College Huazhong University of Science and Technology Recruiting
Wuhan City, China, 430023
Zhejiang Cancer Hospital Recruiting
Zhejiang, China, 310022
France
Institut de Cancerologie de l Ouest Recruiting
Angers, France, 49055
Institut Bergonie; Oncologie Recruiting
Bordeaux, France, 33076
Centre Oscar Lambret; Chir Cancerologie General Withdrawn
Lille, France, 59000
Centre Leon Berard; Departement Oncologie Medicale Recruiting
Lyon, France, 69373
Hôpital de la Timone; Oncologie Médicale Hématologie & Soins Palliatifs Recruiting
Marseille cedex 5, France, 13385
Hôpital Nord - AP-HM Marseille#; Service d'Oncologie Multidisciplinaire Recruiting
Marseille, France, 13015
Institut de Recherche en Cancérologie de Montpellier Recruiting
Montpellier cedex 5, France, 34298
Hôpital Européen Georges Pompidou; Hématologie Oncologie Withdrawn
Paris cedex 15, France, 75908
Institut Curie; Oncologie Medicale Recruiting
Paris, France, 75231
Institut De Cancerologie De L'ouest - Rene Gauducheau - Biology Recruiting
Saint Herblain, France, 44805
Institut Claudius Regaud; Departement Oncologie Medicale Recruiting
Toulouse, France, 31059
Institut Gustave Roussy; Pathologie Thoracique Recruiting
Villejuif cedex, France, 94805
Germany
Charite Universitaetsmedizin Berlin - Campus Charite Mitte ; Charite Comprehensive Cancer Center Withdrawn
Berlin, Germany, 10117
Evang. Lungenklinik Berlin Klinik für Pneumologie Recruiting
Berlin, Germany, 13125
Universitaetsklinikum Carl Gustav Carus TU Dresden Recruiting
Dresden, Germany, 01307
Asklepios-Fachkliniken Muenchen-Gauting; Onkologie Withdrawn
Gauting, Germany, 82131
Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie Recruiting
Göttingen, Germany, 37075
NCT Uniklinikum Heidelberg; Medizinische Onkologie Recruiting
Heidelberg, Germany, 69120
Universitaetsklinikum Koeln; Innere Medizin I, Haematologie Recruiting
Köln, Germany, 50937
Hong Kong
Hong Kong Integrated Oncology Centre Withdrawn
Hong Kong, Hong Kong
Princess Margaret Hospital Recruiting
Hong Kong, Hong Kong
The University of Hong Kong Recruiting
Hong Kong, Hong Kong
Queen Elizabeth Hospital Recruiting
Kowloon, Hong Kong
The Chinese University of Hong Kong Recruiting
Shatin, Hong Kong, 123456
Italy
Seconda Università degli Studi di Napoli; Servizio Epato-Gastroenterologia Recruiting
Napoli, Campania, Italy, 80131
Università Campus Bio-Medico di Roma; Oncologia Medica Recruiting
Roma, Lazio, Italy, 128
Azienda Ospedaliero Universitaria San Martino; Lung Cancer Unit Withdrawn
Genova, Liguria, Italy, 16132
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milano, Lombardia, Italy, 20133
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck Recruiting
Milano, Lombardia, Italy, 20162
Fondazione del Piemonte per l'Oncologia - IRCCS;Ematologia Active, not recruiting
Candiolo, Piemonte, Italy, 10060
Azienda Ospedaliero-Universitaria S.Luigi Gonzaga; SSD Oncologia Polmonare Withdrawn
Orbassano, Piemonte, Italy, 10043
A.O Città della Salute e della Scienza di Torino; Colorectal Cancer Unit (CRCU) - SSCVD Withdrawn
Torino, Piemonte, Italy, 10126
Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico Recruiting
Pisa, Toscana, Italy, 56126
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia ; S.C. Oncologia Medica Recruiting
Perugia, Umbria, Italy, 6132
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II Recruiting
Padova, Veneto, Italy, 35128
Japan
Aichi Cancer Center Hospital; Respiratory Medicine Recruiting
Aichi, Japan, 464-8681
NHO Shikoku Cancer Center; Dept of Respiratory Medicine Recruiting
Ehime, Japan, 791-0280
NHO Kyushu Cancer Center Recruiting
Fukuoka, Japan, 811-1395
Hyogo Cancer Center, Dept of Respiratory Medicine Recruiting
Hyogo, Japan, 673-8558
National Cancer Center Hospital; Dept of Respiratory Medicine Recruiting
Kashiwa-shi, Japan, 277-8577
Miyagi Cancer Center; Respiratory Medicine Recruiting
Miyagi, Japan, 981-1293
Niigata Cancer Center Hospital; Internal Medicine Recruiting
Niigata, Japan, 951-8566
OSAKA CITY GENERAL HOSPITAL;Medical Oncology Recruiting
Osaka, Japan, 534-0021
Kindai University Hospital; Medical Oncology Recruiting
Osaka, Japan, 589-8511
Shizuoka Cancer Center; Respiratory Internal Medicine Recruiting
Shizuoka, Japan, 411-8777
Korea, Republic of
Chungbuk National University Hospital Withdrawn
Cheongju-si, Korea, Republic of, 28644
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, (0)6351
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center. Recruiting
Seoul, Korea, Republic of, 138-736
Netherlands
NKI The Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands, 1066 CX
Leids Universitair Medisch Centrum Recruiting
Leiden, Netherlands, 2333 ZA
Poland
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii Recruiting
Gdańsk, Poland, 80-214
Centrum Onkologii-Instytut im.M.Sklodowskiej Curie; Dept of Nuclear Med. and Endocrine Oncology Recruiting
Gliwice, Poland, 44-101
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Dept of Pulmonology & subdiv. of oncology Withdrawn
Otwock, Poland, 05-400
Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy Recruiting
Poznań, Poland, 60-569
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego Recruiting
Warszawa, Poland, 02-781
Singapore
National University Hospital; Haematology/Oncology Recruiting
Singapore, Singapore, 119074
National Cancer Centre Recruiting
Singapore, Singapore, 169610
Spain
Centro Nacional de Investigaciones Oncológicas(CNIO); Gastrointestinal Cancer Clinical Research Unit Withdrawn
Fuenlabrada, Madrid, Spain, 28942
Hospital Universitari Vall dHebron; Oncology Recruiting
Barcelona, Spain, 08035
Hospital Universitario de La Princesa; Servicio de Oncologia Withdrawn
Madrid, Spain, 28006
Hospital Universitario Ramon y Cajal; Servicio de Farmacia Recruiting
Madrid, Spain, 28034
Hospital Universitario Clínico San Carlos; Servicio de Oncologia Recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre; Servicio de Oncologia Recruiting
Madrid, Spain, 28041
Hospital Universitario La Paz; Servicio de Oncologia Recruiting
Madrid, Spain, 28046
START Madrid. Centro Integral Oncologico Clara Campal; Unidad de Fase I-Oncologica Recruiting
Madrid, Spain, 28050
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia Recruiting
Malaga, Spain, 29010
Hospital Universitario Virgen del Rocio; Servicio de Oncologia Recruiting
Sevilla, Spain, 41013
Taiwan
Changhua Christian Hospital Withdrawn
Chang Hua, Taiwan, 500
Taichung Veterans General Hospital Withdrawn
Taichung, Taiwan, 407
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 70457
Taipei Veterans General Hospital Recruiting
Taipei City, Taiwan, 11217
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
United Kingdom
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Sarah Cannon Research Institute Recruiting
London, United Kingdom, W1G 6AD
Christie Hospital Nhs Trust; Medical Oncology Recruiting
Manchester, United Kingdom, M2O 4BX
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02568267    
Other Study ID Numbers: RXDX-101-02
2015-003385-84 ( EudraCT Number )
GO40782 ( Other Identifier: Hoffman-La Roche )
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Keywords provided by Hoffmann-La Roche:
Entrectinib
RXDX-101
TrkA
TrkB
TrkC
NTRK1
NTRK2
NTRK3
ROS1
ALK
Trk Fusions
NTRK Gene Rearrangements
ROS1 Fusions
ROS1 Gene Rearrangements
ALK Fusions
ALK Gene Rearrangements
Basket study
Non-small cell lung cancer
Colorectal cancer
Salivary gland cancers
Primary brain tumors
Melanoma
Sarcomas
Papillary thyroid cancer
Renal cell cancer
Pancreatic cancer
Breast cancer
Cholangiocarcinoma
Head & Neck cancers
Ovarian cancer
Additional relevant MeSH terms:
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Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Melanoma
Pancreatic Neoplasms
Sarcoma
Ovarian Neoplasms
Brain Neoplasms
Thyroid Neoplasms
Neuroendocrine Tumors
Cholangiocarcinoma
Salivary Gland Neoplasms
Head and Neck Neoplasms
Thyroid Cancer, Papillary
Lymphoma, Large-Cell, Anaplastic
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms