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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
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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:
- - Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene fusion, identified through molecular assays as routinely performed at CLIA or other similarly-certified laboratories.
- - 8.0.
- - 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 (Eisenhauer et al.
- - 8.0, regardless of tumor type.
- - At least 18 years of age.
- - Performance Status: Eastern Cooperative Oncology Group (ECOG) score ≤ 3.
- - Tumor tissue before treatment (mandatory).
- - Adequate organ function as defined by the following criteria: 1.
- - Ability to comply (or for guardian to ensure compliance) with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation.
- - 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:
- - Investigational agent or anticancer therapy within 2 weeks prior to the planned start of larotrectinib or 5 half-lives, whichever is shorter, and without recovery of acute and/or clinically significant toxicities from that therapy.
- - Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK.
- - Symptomatic or unstable brain metastases.
- - Uncontrolled concurrent malignancy that would limit assessment of efficacy of larotrectinib.
- - Active uncontrolled systemic bacterial, viral, or fungal infection CTCAE grade ≥ 2; unstable cardiovascular disease, or other systemic disease that would limit compliance with study procedures.
- - Inability to discontinue treatment with a strong CYP3A4 inhibitor or inducer.
- - Currently recovering from AEs/ ADRs due to previous treatments (excluding alopecia).
- - Known or suspected hypersensitivity against the active substance or any of the ingredients of the IMP.
- - Known history of HIV infection.
- - HBV or HCV infection.
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. |
NCT02576431 |
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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. |
Bayer |
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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 |
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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 | Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Czechia, Denmark, France, Germany, India, Ireland, Italy, Japan, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Solid Tumors Harboring NTRK Fusion |
| Study Website: | View Trial Website |
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 (arm 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
Address
Stanford Cancer Center Palo Alto
Palo Alto 5380748, California 5332921, 94304
Status
Address
UCLA Health Santa Monica Cancer Care
Santa Monica 5393212, California 5332921, 90404
Status
Address
Memorial Cancer Institute at West
Pembroke Pines 4168139, Florida 4155751, 33026
Status
Address
The University of Chicago Medical Center - Hyde Park - Hematology & Oncology
Chicago 4887398, Illinois 4896861, 60637
Status
Address
Mass General Cancer Center
Boston 4930956, Massachusetts 6254926, 02114-2696
Status
Address
Dana-Farber Cancer Institute - Oncology Department
Boston 4930956, Massachusetts 6254926, 02215
Status
Address
Memorial Sloan Kettering Cancer Center New York - Main Campus
New York 5128581, New York 5128638, 10065
Status
Address
UNC Hospitals - UNC Lineberger Comprehensive Cancer Center
Chapel Hill 4460162, North Carolina 4482348, 27514
Status
Address
Wake Forest Baptist Health
Winston-Salem 4499612, North Carolina 4482348, 27157
Status
Address
Cleveland Clinic - Neurology
Cleveland 5150529, Ohio 5165418, 44195
Status
Address
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia 4560349, Pennsylvania 6254927, 19107
Status
Address
Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927, 19111
Status
Address
Avera Cancer Institute - Sioux Falls
Sioux Falls 5231851, South Dakota 5769223, 57105
Status
Address
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168, 37232
Status
Address
The University of Texas MD Anderson Cancer Center - Texas Medical Center
Houston 4699066, Texas 4736286, 77030
Status
Address
Inova Schar Cancer Institute
Fairfax 4758023, Virginia 6254928, 22031
Status
Address
University of Washington
Seattle 5809844, Washington 5815135, 0
Status
Address
West Virginia University
Morgantown 4815352, West Virginia 4826850, 26505
International Sites
Status
Address
Hospital Alemán
Buenos Aires 3435910, Ciudad Auton. de Buenos Aires, C11118AAT
Status
Address
Centro Estudios Médicos e Invest. Clínicas "Dr. N. Quirno"
Buenos Aires 3435910, Ciudad Auton. de Buenos Aires, TBC
Status
Address
Fundación Cenit para la Investigación en Neurociencias
CABA, Ciudad Auton. de Buenos Aires, C1125 ABD
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Address
Centro Medico Austral
TBC, Ciudad Auton. de Buenos Aires, C1019ABS
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Address
Centro Médico San Roque
San Miguel de Tucumán 3836873, Tucumán Province 3833578, T4000HXU
Status
Address
Macquarie University Hospital
Sydney 2147714, New South Wales 2155400, 2109
Status
Address
Royal Darwin Hospital
Tiwi 8347832, Northern Territory 2064513, 810
Status
Address
St John of God Healthcare
Subiaco 2060886, Western Australia 2058645, 6008
Status
Address
Institut Jules Bordet/Jules Bordet Instituut
Brussels 2800866, , 1070
Status
Address
Hosp. Araujo Jorge da Associação de Combate ao Câncer
Goiânia 3462377, Goiás 3462372, 74605-070
Status
Address
Cenantron Centro Avançado de Tratamento Oncológico, Ltda.
Belo Horizonte 3470127, Minas Gerais 3457153, 30130-090
Status
Address
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos/SP, São Paulo 3448433, 14784-400
Status
Address
Instituto do Cancer do Estado de Sao Paulo
São Paulo 3448439, São Paulo 3448433, 01246-000
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Address
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo 3448439, São Paulo 3448433, 01323-001
Status
Address
IBCC - Instituto Brasileiro de Controle do Cancer
São Paulo 3448439, São Paulo 3448433, 03102-002
Status
Address
Instituto Nacional do Câncer - INCA - HC II
Rio de Janeiro 3451190, , 20081-250
Status
Address
INCA - Hospital do Cancer III
Rio de Janeiro 3451190, , 20560-120
Status
Address
Oncoclínicas Rio de Janeiro S.A
Rio de Janeiro 3451190, , 22250-905
Status
Address
Hospital Sirio Libanes
São Paulo 3448439, , 01409-000
Status
Address
Tom Baker Cancer Centre
Calgary 5913490, Alberta 5883102, T2N 4N2
Status
Address
Beijing Cancer Hospital - Oncology Department
Beijing 1816670, Beijing Municipality 2038349, 100142
Status
Address
Sun Yat-sen University Cancer Center
Guangzhou 1809858, Guangdong 1809935, 510000
Status
Address
Sichuan University West China Hospital
Chengdu 1815286, Sichuan 1794299, MISSING
Status
Address
Zhongshan Hospital, Fudan University - Oncology Department
Shanghai 1796236, , 200032
Status
Address
Instituto Nacional de Cancerología INC Colombia
Bogota, Cundinamarca 3685413, 111511
Status
Address
Oncomédica S.A.
Montería 3674453, Departamento de Córdoba 3685889, 230002
Status
Address
Fundación Oftalmológica de Santander Carlos Ardila Lule
Floridablanca 3682385, Santander Department 3668578, 681004
Status
Address
Fakultní Nemocnice Olomouc
Olomouc 3069011, , 77900
Status
Address
Rigshospitalet - Kræftbehandling
Copenhagen OE, , 2100
Status
Address
Hopital Jean Minjoz
Besançon 3033123, , 25030
Status
Address
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
Bordeaux 3031582, , 33000
Status
Address
Centre Antoine Lacassagne - Departement Oncologie
Nice 2990440, , 06100
Status
Address
Hopital Saint Antoine APHP - Departement Oncologie
Paris 2988507, , 75012
Status
Address
APHP-Hopital la Pitie Salpetriere-Departement oncologie
Paris 2988507, , 75013
Status
Address
Hôpital de la Milétrie
Poitiers 2986495, , 86021
Status
Address
Institut de Cancerologie Ouest - Saint-Herblain
Saint-Herblain 2979590, , 44800
Status
Address
ICANS - Institut de Cancerologie de Strasbourg Europe - service oncologie medicale
Strasbourg 2973783, , 67200
Status
Address
Charité Comprehensive Cancer Center (CCCC)
Berlin 2950159, , 12203
Status
Address
All India Institute of Medical Sciences
Bhubaneswar 1275817, Odisha 1261029, 751019
Status
Address
Jawaharlal Institute Of Postgraduate Medical Education and R
Gorimedu, Puducherry 1259424, 605006
Status
Address
St Vincents University Hospital
Dublin 2964574, , TBC
Status
Address
A.O.R.N. San Giuseppe Moscati
Avellino 3182650, Campania 3181042, 83100
Status
Address
A.O.U. di Bologna Policlinico S.Orsola Malpighi
Bologna 3181928, Emilia-Romagna 3177401, 40138
Status
Address
A.S.U. Friuli Centrale - A. Regionale Coordinamento Salute
Udine 3165072, Friuli Venezia Giulia 3176525, 33038
Status
Address
IRCCS Istituti Fisioterapici Ospitalieri - IFO
Rome 3169070, Lazio 3174976, 144
Status
Address
Istituto Europeo di Oncologia s.r.l
Milan 3173435, Lombardy 3174618, 20141
Status
Address
Istituto Oncologico Veneto
Padua 3171728, Veneto 3164604, 35128
Status
Address
Nagoya University Hospital
Nagoya 1856057, Aichi-ken 1865694, 466-8560
Status
Address
National Cancer Center Hospital East
Kashiwa 1859924, Chiba 2113014, 277-8577
Status
Address
Hokkaido University Hospital
Sapporo 2128295, Hokkaido 2130037, 060-8648
Status
Address
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo 1850144, 135-8550
Status
Address
IPO Porto
Porto 2735943, , 4200-072
Status
Address
Arkhangelsk Clinical Oncology Dispensary
Arkhangelsk 581049, , 163045
Status
Address
Republican Clinical Oncology Dispensary Kazan
Kazan' 551487, , 420029
Status
Address
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS
Moscow 524901, , 115478
Status
Address
1st Moscow State Medical University n.a. I.M.Sechenov
Moscow 524901, , 119991
Status
Address
Clinical Diagnostical Center
Nizhny Novgorod 520555, , 603006
Status
Address
St. Petersburg Clinical Onc. Cent. of Spec. Types of Care
Saint Petersburg 498817, , 197758
Status
Address
National Cancer Center Singapore - Oncology Department
Singapore 1880252, , 168583
Status
Address
Onkologicky Ustav Svatej Alzbety, s.r.o.
Bratislava 3060972, , 812 50
Status
Address
Narodny onkologicky ustav
Bratislava 3060972, , 833 10
Status
Address
Severance Hospital, Yonsei University Health System
Seoul 1835848, Seoul Teugbyeolsi, 03722
Status
Address
Asan Medical Center - Oncology Department
Seoul 1835848, Seoul Teugbyeolsi, 05505
Status
Address
Seoul National University Hospital
Seoul 1835848, Seoul Teugbyeolsi, 3080
Status
Address
Samsung Medical Center - Oncology Department
Seoul 1835848, , 06351
Status
Address
Institut Catala D'oncologia - Oncologia
Barcelona 3128760, L Hospitalet de Llobregat, 8907
Status
Address
Hospital del Mar
Barcelona 3128760, , 08003
Status
Address
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
Barcelona 3128760, , 08035
Status
Address
Hospital General Universitario Gregorio Maranon | Oncologia
Madrid 3117735, , 28007
Status
Address
Fundacion Jimenez Diaz (Clinica de la Concepcion)
Madrid 3117735, , 28040
Status
Address
Centro Integral Oncológico Clara Campal
Madrid 3117735, , 28050
Status
Address
Karolinska Universitetssjukhuset Solna - Tema Cancer
Stockholm 2673730, , 171 76
Status
Address
Tri-Service General Hospital
Taipei 1668341, , 114
Status
Address
Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital
Ankara 323786, , 6800
Status
Address
Trakya Univ. Tip Fak.
Edirne 747712, , 22030
Status
Address
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul 745044, , 34093
Status
Address
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
Istanbul 745044, , 34098
Status
Address
TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has
Istanbul 745044, , 34722
Status
Address
Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma
Izmir 311046, , 35360
Status
Address
Erciyes Universitesi Tip Fakultesi
Kayseri 308464, , 38039
