A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors
Study Purpose
This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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:
- - Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene fusion, identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) or other similarly-certified laboratories.
- - Subjects who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments and in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.
- - Subjects must have at least one measurable lesion as defined by RECIST v1.1.
- - 8.0, regardless of tumor type.
- - Performance Status: Eastern Cooperative Oncology Group (ECOG) score ≤ 3 If enrolled with primary CNS tumor to be assessed by RANO, Karnofsky Performance Score (KPS) ≥50% - Tumor tissue before treatment (mandatory).
- - Willingness of men and women of reproductive potential to use double effective birth control methods, defined as one used by the subject and another by his/her partner, for the duration of treatment and for 1 month following study completion.
- - For subjects eligible for enrollment to bone health cohort only: life expectancy of at least 6 months, based on investigator assessment.
Exclusion Criteria:
- - Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting tropomyosin receptor kinase (TRK).
- - Symptomatic or unstable brain metastases.
- - Pregnancy or lactation.
- - Active uncontrolled systemic bacterial, viral, or fungal infection Common Terminology Criteria for Adverse Events(CTCAE) grade ≥ 2; unstable cardiovascular disease, or other systemic disease that would limit compliance with study procedures.
- - Unstable cardiovascular disease is defined as: - In adults, persistently uncontrolled hypertension defined as systolic blood pressure (BP) > 150 mmHg and/or diastolic BP > 100 mmHg despite antihypertensive therapy.
- - Myocardial infarction within 3 months of screening.
- - Stroke within 3 months of screening.
Trial Details
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. |
NCT02576431 |
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 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Bayer |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Korea, Republic of, Norway, Poland, Portugal, Russian Federation, Singapore, Slovakia, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Solid Tumors Harboring NTRK Fusion |
The primary objective of this study is to investigate the efficacy of larotrectinib for the treatment of advanced solid tumors harboring a fusion of neurotrophic tyrosine receptor kinase (NTRK) of types 1-3 in children and adults. Secondary objectives comprise the efficacy and safety of larotrectinib in different NTRK-tumor types.
Arms
Experimental: Arm 1_NSCLC
Patients with solid non-small cell lung cancer (NSCLC) harboring NTRK fusions (arm closed)
Experimental: Arm 2_Thyroid
Patients with solid thyroid tumors harboring NTRK fusions (arm closed)
Experimental: Arm 3_Sarcoma
Patients with soft-tissue sarcoma harboring NTRK fusions (arm closed)
Experimental: Arm 4_Colorectal
Patients with solid colorectal tumors harboring NTRK fusions (arm closed)
Experimental: Arm 5_Salivary
Patients with solid salivary tumors harboring NTRK fusions (arm closed)
Experimental: Arm 6_Biliary
Patients with solid biliary tumors harboring NTRK fusions (arm closed)
Experimental: Arm 7_Primary CNS
Patients with solid tumors in the primary central nervous system (CNS) harboring NTRK fusions (arm closed)
Experimental: Arm 8_Other tumors
Patients with e.g. kidney cancer, squamous cell cancer of head or neck or ovarian solid tumors harboring NTRK fusions (arm closed)
Experimental: Arm 9_Solid tumors without confirmed NTRK fusion
Patients eligible for arms 1 to 8, but with documented NTRK fusion from a laboratory where CLIA or equivalent certification cannot be confirmed by the sponsor at the time of consent (arm closed)
Experimental: Arm 10- Prospective cohort
Patients with melanoma, non secretory breast and colorectal cancer or other tumor types harboring NTRK fusions, except soft tissue sarcoma, salivary gland and thyroid cancer (closed)
Experimental: Arm 11_Bone health cohort
Patients with all tumor types harboring NTRK fusions, not eligible for the main prospective cohort, including patients with non-measurable disease
Interventions
Drug: - BAY2757556 (Larotrectinib, Vitrakvi)
Larotrectinib will be administered orally as capsule or liquid solution at a dose of 100 mg twice daily in continuing 28-days cycles.
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
Completed
Address
Stanford Cancer Center
Palo Alto, California, 94304
Status
Active, not recruiting
Address
UCLA-Santa Monica Medical Center
Santa Monica, California, 90404
Status
Completed
Address
Memorial Hospital West
Pembroke, Florida, 33028
Status
Completed
Address
University of Chicago
Chicago, Illinois, 60637
Status
Active, not recruiting
Address
Massachusetts General Hospital
Boston, Massachusetts, 02114
Status
Active, not recruiting
Address
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Status
Withdrawn
Address
Dartmouth Hitchock Medical Center
Lebanon, New Hampshire, 03756
Status
Active, not recruiting
Address
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Status
Active, not recruiting
Address
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
Status
Completed
Address
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157-1082
Status
Completed
Address
Cleveland Clinic Foundation
Cleveland, Ohio, 44195-0002
Status
Active, not recruiting
Address
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Status
Completed
Address
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Status
Completed
Address
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Status
Active, not recruiting
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Status
Recruiting
Address
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Status
Active, not recruiting
Address
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Status
Completed
Address
University of Washington
Seattle, Washington, 98109
Status
Completed
Address
West Virginia University
Morgantown, West Virginia, 26505
International Sites
Status
Withdrawn
Address
Centro Medico Austral
Buenos Aires, Ciudad Auton. De Buenos Aires, C1019ABS
Status
Withdrawn
Address
Hospital Británico
Buenos Aires, Ciudad Auton. De Buenos Aires, C1280AEB
Status
Withdrawn
Address
Centro Estudios Médicos e Invest. Clínicas "Dr. N. Quirno"
Buenos Aires, Ciudad Auton. De Buenos Aires, C1431FWO
Status
Recruiting
Address
Hospital Alemán
Buenos Aires, Ciudad Auton. De Buenos Aires,
Status
Withdrawn
Address
Fundación Cenit para la Investigación en Neurociencias
Caba, Ciudad Auton. De Buenos Aires, C1125 ABD
Status
Withdrawn
Address
Instituto Medico Especializado Alexander Fleming
Caba, Ciudad Auton. De Buenos Aires, C1426
Status
Recruiting
Address
Instituto de Oncología de Rosario
Rosario, Santa Fe, S2000KZE
Status
Withdrawn
Address
Centro Médico San Roque
San Miguel de Tucumán, Tucuman, T4000HXU
Status
Recruiting
Address
Macquarie University Hospital
Macquarie University, New South Wales, 2109
Status
Recruiting
Address
Royal Darwin Hospital
Tiwi, Northern Territory, 0810
Status
Recruiting
Address
St John of God Healthcare
Subiaco, Western Australia, 6008
Status
Withdrawn
Address
Sir Charles Gairdner Hospital
Nedlands, , 6009
Status
Withdrawn
Address
Institut Jules Bordet/Jules Bordet Instituut
Anderlecht, , 1070
Status
Recruiting
Address
Hosp. Araujo Jorge da Associação de Combate ao Câncer
Goiânia, Goiás, 74605-070
Status
Recruiting
Address
Cenantron Centro Avançado de Tratamento Oncológico, Ltda.
Belo Horizonte, Minas Gerais, 30110-090
Status
Recruiting
Address
Associação Hospital de Caridade de Ijuí
Ijuí, Rio Grande Do Sul, 98700-000
Status
Recruiting
Address
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande Do Sul, 90050-170
Status
Recruiting
Address
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, Sao Paulo, 14784-400
Status
Recruiting
Address
Hospital de Base da Fundação F M S J Rio Preto
São José do Rio Preto, Sao Paulo, 15090-000
Status
Recruiting
Address
Instituto do Câncer do Estado de São Paulo
São Paulo, Sao Paulo, 01246-000
Status
Recruiting
Address
Clín. de Pesq. e Centro de Estudos em Onco Gineco Mamária
São Paulo, Sao Paulo, 01317-000
Status
Recruiting
Address
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, Sao Paulo, 01323-001
Status
Recruiting
Address
IBCC - Instituto Brasileiro de Controle do Cancer
São Paulo, Sao Paulo, 04014-002
Status
Recruiting
Address
Instituto Nacional do Câncer - INCA - HC II
Rio de Janeiro, , 20220-410
Status
Recruiting
Address
INCA - Hospital do Cancer III
Rio de Janeiro, , 20560-121
Status
Recruiting
Address
Oncoclínicas Rio de Janeiro S.A
Rio de Janeiro, , 22250-905
Status
Recruiting
Address
Hospital Sirio Libanes
Sao Paulo, , 01308-050
Status
Recruiting
Address
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Status
Recruiting
Address
Juravinski Cancer Centre-McMaster Medical Unit
Hamilton, Ontario, L8V 5C2
Status
Recruiting
Address
London Regional Cancer Program, London Health Sciences Ctr
London, Ontario, N6A 5W9
Status
Withdrawn
Address
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2
Status
Recruiting
Address
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Status
Recruiting
Address
Sichuan University West China Hospital
Chengdu, Sichuan,
Status
Recruiting
Address
Beijing Cancer Hospital
Beijing, , 100142
Status
Recruiting
Address
Zhongshan Hospital, Fudan University
Shanghai, , 200032
Status
Recruiting
Address
Instituto Nacional de Cancerología INC Colombia
Bogotá, Cundinamarca, 111511
Status
Recruiting
Address
Oncomédica S.A.
Montería, Córdoba, 230002
Status
Recruiting
Address
Fundación Oftalmológica de Santander Carlos Ardila Lule
Floridablanca, Santander, 681004
Status
Recruiting
Address
Masarykuv onkologicky ustav
Brno, , 65 653
Status
Recruiting
Address
Fakultni Nemocnice Hradec Kralove
Hradec Kralove, , 500 05
Status
Recruiting
Address
Fakultni Nemocnice Olomouc
Olomouc, , 77900
Status
Recruiting
Address
Fakultni Thomayerova Nemocnice
Praha 4, , 140 59
Status
Recruiting
Address
Finsen Centre
Copenhagen, , 2100
Status
Recruiting
Address
Hopital Jean Minjoz
Besancon, , 25030
Status
Recruiting
Address
Institut Bergonié - Unicancer Nouvelle Aquitaine
Bordeaux Cedex, , 33076
Status
Withdrawn
Address
Hôpital Saint André - Bordeaux
Bordeaux, , 33000
Status
Recruiting
Address
Hôpital Saint André - Bordeaux
Bordeaux, , 33000
Status
Recruiting
Address
Centre Léon Bérard
Lyon Cedex, , 39373
Status
Recruiting
Address
Centre Antoine Lacassagne
Nice Cedex 2, , 06102
Status
Recruiting
Address
Hôpital Saint Louis
Paris, , 75010
Status
Recruiting
Address
Hopital Saint Antoine - Paris
Paris, , 75012
Status
Recruiting
Address
Hôpital de la Pitié-Salpétrière
Paris, , 75651
Status
Recruiting
Address
Centre Hospitalier Lyon Sud
Pierre Benite, , 69495
Status
Recruiting
Address
Hôpital de la Milétrie
POITIERS cedex, , 86021
Status
Recruiting
Address
Hôpital Guillaume et René Laennec - Nantes
Saint Herblain, , 44093
Status
Recruiting
Address
Institut de Cancérologie de l'Ouest - Saint Herblain
Saint-Herblain, , 44800
Status
Recruiting
Address
ICANS - Institut de Cancérologie de Strasbourg Europe
Strasbourg, , 67033
Status
Not yet recruiting
Address
Uniklinik Heidelberg / NCT
Heidelberg, Baden-Württemberg, 69120
Status
Withdrawn
Address
Heinrich-Heine-Universität Düsseldorf
Düsseldorf, Nordrhein-Westfalen, 40225
Status
Withdrawn
Address
Universitätsklinikum Essen
Essen, Nordrhein-Westfalen, 45122
Status
Recruiting
Address
Charité Comprehensive Cancer Center (CCCC)
Berlin, , 12203
Status
Recruiting
Address
AGIOS SAVVAS Anticancer Hospital of Athens
Athens, , 115 22
Status
Recruiting
Address
LAIKO General Hospital of Athens
Athens, , 11526
Status
Recruiting
Address
General Hospital of Athens "ALEXANDRA"
Athens, , 11528
Status
Recruiting
Address
General Oncology Hospital of Kifissia AGIOI ANARGYROI
Kifissia / Athens, , 14564
Status
Recruiting
Address
University General Hospital of Patra
Patra, , 26504
Status
Recruiting
Address
MH Egeszsegugyi Kozpont
Budapest, , 1062
Status
Recruiting
Address
Orszagos Onkologiai Intezet
Budapest, , 1122
Status
Recruiting
Address
Debreceni Egyetem Klinikai Kozpont
Debrecen, , 4032
Status
Recruiting
Address
Bacs-Kiskun Megyei Korhaz
Kecskemet, , 6000
Status
Recruiting
Address
All India Institute of Medical Sciences
New Delhi, Delhi, 110029
Status
Recruiting
Address
Tata Memorial Hospital
Mumbai,, Maharashtra, 400012
Status
Recruiting
Address
Kokilaben Dhirubhai Ambani Hospital & Medical Research Insti
Mumbai, Maharashtra, 400053
Status
Recruiting
Address
HCG Manavata Cancer Centre
Nashik, Maharashtra, 422002
Status
Recruiting
Address
Jawaharlal Institute Of Postgraduate Medical Education and R
Gorimedu, Pondicherry, 605006
Status
Recruiting
Address
Chittaranjan National Cancer Institute
Kolkata, West Bengal, 700026
Status
Recruiting
Address
St Vincents University Hospital
Dublin, , DUBLIN 4
Status
Recruiting
Address
A.O.R.N. San Giuseppe Moscati
Avellino, Campania, 83100
Status
Recruiting
Address
A.O.U. di Bologna Policlinico S.Orsola Malpighi
Bologna, Emilia-Romagna, 40138
Status
Recruiting
Address
A.S.U. Friuli Centrale - A. Regionale Coordinamento Salute
Udine, Friuli-Venezia Giulia, 33100
Status
Recruiting
Address
IRCCS Istituti Fisioterapici Ospitalieri - IFO
Roma, Lazio, 00144
Status
Recruiting
Address
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Lazio, 00168
Status
Recruiting
Address
IRCCS Ospedale Policlinico San Martino
Genova, Liguria, 16132
Status
Recruiting
Address
Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
Milano, Lombardia, 20089
Status
Recruiting
Address
IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)
Milano, Lombardia, 20141
Status
Recruiting
Address
ASST Grande Ospedale Metropolitano Niguarda
Milano, Lombardia, 20162
Status
Recruiting
Address
Istituto Oncologico Veneto IRCCS (IOV)
Padova, Veneto, 35128
Status
Active, not recruiting
Address
Nagoya University Hospital
Nagoya, Aichi, 466-8560
Status
Active, not recruiting
Address
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Status
Completed
Address
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Status
Active, not recruiting
Address
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Status
Recruiting
Address
Seoul National University Hospital
Seoul, , 03080
Status
Recruiting
Address
Severance Hospital, Yonsei University Health System
Seoul, , 03722
Status
Recruiting
Address
Asan Medical Center
Seoul, , 05505
Status
Recruiting
Address
Samsung Medical Center
Seoul, , 06351
Status
Recruiting
Address
Korea University Anam Hospital
Seoul, , 136-705
Status
Recruiting
Address
Radium Hospital Department of Oncology
Oslo, , 0379
Status
Recruiting
Address
Wojskowy Instytut Medyczny
Warszawa, , 04-141
Status
Recruiting
Address
Fundacao Champalimaud
Lisboa, , 1400-038
Status
Recruiting
Address
CHULN - Hospital Santa Maria
Lisboa, , 1649-035
Status
Withdrawn
Address
Centro Hospitalar Universitario do Porto
Porto, , 4099-001
Status
Recruiting
Address
IPO Porto
Porto, , 4200-072
Status
Recruiting
Address
Arkhangelsk Clinical Oncology Dispensary
Arkhangelsk, , 163045
Status
Recruiting
Address
Ltd "EVIMED"
Chelyabinsk, , 454048
Status
Recruiting
Address
Republican Clinical Oncology Dispensary Kazan
Kazan, , 420029
Status
Withdrawn
Address
Moscow Clinical Scientific Centre n.a.Loginov
Moscow, , 111123
Status
Withdrawn
Address
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS
Moscow, , 115478
Status
Recruiting
Address
1st Moscow State Medical University n.a. I.M.Sechenov
Moscow, , 119435
Status
Recruiting
Address
Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen
Moscow, , 125284
Status
Recruiting
Address
City Oncological Hospital #62
Moscow, , 143423
Status
Recruiting
Address
Clinical Diagnostical Center
Nizhny Novgorod, , 603006
Status
Recruiting
Address
St. Petersburg Clinical Onc. Cent. of Spec. Types of Care
St. Petersburg, , 197758
Status
Recruiting
Address
National Cancer Center Singapore
Singapore, , 169610
Status
Withdrawn
Address
Onkologicky Ustav Svatej Alzbety, s.r.o.
Bratislava, , 812 50
Status
Recruiting
Address
Narodny onkologicky ustav
Bratislava, , 833 10
Status
Recruiting
Address
Institut Català d'Oncologia Hospitalet
Hospitalet de Llobregat, Barcelona, 08907
Status
Recruiting
Address
Hospital Universitario "Marqués de Valdecilla"
Santander, Cantabria, 39008
Status
Recruiting
Address
Hospital del Mar
Barcelona, , 08003
Status
Recruiting
Address
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
Barcelona, , 08023
Status
Recruiting
Address
Hospital Clínic i Provincial de Barcelona
Barcelona, , 08036
Status
Recruiting
Address
Hospital General Universitario Gregorio Marañón | Oncología
Madrid, , 28007
Status
Recruiting
Address
Fundacion Jimenez Diaz (Clinica de la Concepcion)
Madrid, , 28040
Status
Recruiting
Address
Centro Integral Oncológico Clara Campal
Madrid, , 28050
Status
Recruiting
Address
Hospital Clínico Universitario de Valencia
Valencia, , 46010
Status
Recruiting
Address
Hospital General Universitario de Valencia
Valencia, , 46014
Status
Recruiting
Address
Karolinska Universitetssjukhuset i Solna
Stockholm, , 171 76
Status
Recruiting
Address
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung, , 833
Status
Recruiting
Address
National Taiwan University Hospital
Taipei, , 100
Status
Recruiting
Address
Tri-Service General Hospital
Taipei, ,
Status
Recruiting
Address
Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital
Ankara, , 6800
Status
Recruiting
Address
Trakya Univ. Tip Fak.
Edirne, , 22030
Status
Recruiting
Address
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, , 34093
Status
Recruiting
Address
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
Istanbul, , 34098
Status
Recruiting
Address
TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has
Istanbul, , 34724
Status
Recruiting
Address
Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma
Izmir, , 35360
Status
Recruiting
Address
Erciyes Universitesi Tip Fakultesi
Kayseri, , 38039
Status
Withdrawn
Address
National Cancer Institute-Ukraine
Kiev, , 03022
Status
Withdrawn
Address
Southampton General Hospital
Southampton, Hampshire, SO16 6YD
Status
Recruiting
Address
Beatson West of Scotland Cancer Centre
Glasgow, , G12 0YN
Status
Recruiting
Address
Institute Of Cancer-Barts and The London School of Medicine
London, , EC1M 6BQ
Status
Recruiting
Address
University College Hospital
London, , W1T 7HA