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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, Korea, Republic of, Portugal, Russian Federation, Singapore, Slovakia, Spain, Sweden, Taiwan, Turkey, 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, California, 94304
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Address
UCLA-Santa Monica Medical Center
Santa Monica, California, 90404
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Address
Memorial Cancer Institute at West
Pembroke Pines, Florida, 33026
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Address
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, 60637
Status
Address
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
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Address
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Status
Address
Memorial Sloan Kettering Cancer Center - New York
New York, New York, 10021
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Address
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27312
Status
Address
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Status
Address
Cleveland Clinic - Neurology
Cleveland, Ohio, 44195
Status
Address
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Status
Address
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
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Address
Avera Cancer Institute - Sioux Falls
Sioux Falls, South Dakota, 57105
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Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Status
Address
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Status
Address
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Status
Address
University of Washington
Seattle, Washington, 0
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Address
West Virginia University
Morgantown, West Virginia, 26505
International Sites
Status
Address
Centro Estudios Médicos e Invest. Clínicas "Dr. N. Quirno"
Buenos Aires, Ciudad Auton. De Buenos Aires, TBC
Status
Address
Hospital Alemán
Buenos Aires, Ciudad Auton. De Buenos Aires, TBC
Status
Address
Fundación Cenit para la Investigación en Neurociencias
Caba, Ciudad Auton. De Buenos Aires, C1125 ABD
Status
Address
Centro Medico Austral
TBC, Ciudad Auton. De Buenos Aires, C1019ABS
Status
Address
Centro Médico San Roque
San Miguel de Tucumán, Tucuman, T4000HXU
Status
Address
Macquarie University Hospital
Sydney, New South Wales, 2109
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Address
Royal Darwin Hospital
Tiwi, Northern Territory, 810
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Address
St John of God Healthcare
Subiaco, Western Australia, 6008
Status
Address
Institut Jules Bordet/Jules Bordet Instituut
Bruxelles, , 1070
Status
Address
Hosp. Araujo Jorge da Associação de Combate ao Câncer
Goiânia, Goiás, 74605-070
Status
Address
Cenantron Centro Avançado de Tratamento Oncológico, Ltda.
Belo Horizonte, Minas Gerais, 30130-090
Status
Address
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos/SP, Sao Paulo, 14784-400
Status
Address
Instituto do Cancer do Estado de Sao Paulo
São Paulo, Sao Paulo, 01246-000
Status
Address
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, Sao Paulo, 01323-001
Status
Address
IBCC - Instituto Brasileiro de Controle do Cancer
São Paulo, Sao Paulo, 03102-002
Status
Address
Instituto Nacional do Câncer - INCA - HC II
Rio de Janeiro, , 20081-250
Status
Address
INCA - Hospital do Cancer III
Rio de Janeiro, , 20560-120
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Address
Oncoclínicas Rio de Janeiro S.A
Rio de Janeiro, , 22250-905
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Address
Hospital Sirio Libanes
Sao Paulo, , 01409-000
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Address
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Status
Address
Beijing Cancer Hospital
Beijing, Beijing, 100142
Status
Address
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Status
Address
Sichuan University West China Hospital
Chengdu, Sichuan, MISSING
Status
Address
Zhongshan Hospital, Fudan University
Shanghai, , 200032
Status
Address
Instituto Nacional de Cancerología INC Colombia
Bogota, Cundinamarca, 111511
Status
Address
Oncomédica S.A.
Montería, Córdoba, 230002
Status
Address
Fundación Oftalmológica de Santander Carlos Ardila Lule
Florida Blanca, Santander, 681004
Status
Address
Fakultní Nemocnice Olomouc
Olomouc, , 77900
Status
Address
Rigshospitalet - Kræftbehandling
Copenhagen OE, , 2100
Status
Address
Hopital Jean Minjoz
Besancon, , 25030
Status
Address
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
Bordeaux, , 33000
Status
Address
Centre Antoine Lacassagne - Departement Oncologie
Nice, , 06100
Status
Address
Hopital Saint Antoine APHP - Departement Oncologie
Paris, , 75012
Status
Address
APHP-Hopital la Pitie Salpetriere-Departement oncologie
Paris, , 75013
Status
Address
Hôpital de la Milétrie
Poitiers, , 86021
Status
Address
Institut de Cancerologie Ouest - Saint-Herblain
Saint-Herblain, , 44800
Status
Address
ICANS - Institut de Cancerologie de Strasbourg Europe - service oncologie medicale
Strasbourg, , 67200
Status
Address
Charité Comprehensive Cancer Center (CCCC)
Berlin, , 12203
Status
Address
All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019
Status
Address
Jawaharlal Institute Of Postgraduate Medical Education and R
Gorimedu, Pondicherry, 605006
Status
Address
St Vincents University Hospital
Dublin 4, , TBC
Status
Address
A.O.R.N. San Giuseppe Moscati
Avellino, Campania, 83100
Status
Address
A.O.U. di Bologna Policlinico S.Orsola Malpighi
Bologna, Emilia-Romagna, 40138
Status
Address
A.S.U. Friuli Centrale - A. Regionale Coordinamento Salute
Udine, Friuli-Venezia Giulia, 33038
Status
Address
IRCCS Istituti Fisioterapici Ospitalieri - IFO
Roma, Lazio, 144
Status
Address
Istituto Europeo di Oncologia s.r.l
Milano, Lombardia, 20141
Status
Address
Istituto Oncologico Veneto
Padova, Veneto, 35128
Status
Address
Nagoya University Hospital
Nagoya, Aichi, 466-8560
Status
Address
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Status
Address
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Status
Address
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Status
Address
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722
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Address
Asan Medical Center
Seoul, Seoul Teugbyeolsi, 05505
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Address
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 3080
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Address
Samsung Medical Center
Seoul, , 06351
Status
Address
IPO Porto
Porto, , 4200-072
Status
Address
Arkhangelsk Clinical Oncology Dispensary
Arkhangelsk, , 163045
Status
Address
Republican Clinical Oncology Dispensary Kazan
Kazan, , 420029
Status
Address
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS
Moscow, , 115478
Status
Address
1st Moscow State Medical University n.a. I.M.Sechenov
Moscow, , 119991
Status
Address
Clinical Diagnostical Center
Nizhny Novgorod, , 603006
Status
Address
St. Petersburg Clinical Onc. Cent. of Spec. Types of Care
St. Petersburg, , 197758
Status
Address
National Cancer Center Singapore
Singapore, , 168583
Status
Address
Onkologicky Ustav Svatej Alzbety, s.r.o.
Bratislava, , 812 50
Status
Address
Narodny onkologicky ustav
Bratislava, , 833 10
Status
Address
Institut Català d'Oncologia Hospitalet
Hospitalet de Llobregat, Barcelona, 08907
Status
Address
Hospital del Mar
Barcelona, , 08003
Status
Address
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
Barcelona, , 08035
Status
Address
Hospital General Universitario Gregorio Maranon | Oncologia
Madrid, , 28007
Status
Address
Fundacion Jimenez Diaz (Clinica de la Concepcion)
Madrid, , 28040
Status
Address
Centro Integral Oncológico Clara Campal
Madrid, , 28050
Status
Address
Karolinska Universitetssjukhuset Solna - Tema Cancer
Stockholm, , 171 76
Status
Address
Tri-Service General Hospital
Taipei City, , 114
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Address
Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital
Ankara, , 6800
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Address
Trakya Univ. Tip Fak.
Edirne, , 22030
Status
Address
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, , 34093
Status
Address
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
Istanbul, , 34098
Status
Address
TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has
Istanbul, , 34722
Status
Address
Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma
Izmir, , 35360
Status
Address
Erciyes Universitesi Tip Fakultesi
Kayseri, , 38039
