Breast Cancer Clinical Trial

A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors

Summary

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.

View Full Description

Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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. Subjects with solid tumors without RECIST v1.1 measurable disease (e.g., evaluable disease only) had been eligible for enrollment to Cohort 8 as per protocol versions 1.0 - 8.0, regardless of tumor type. Subjects with primary CNS tumors should meet the following criteria

Have received prior treatment including radiation and/or chemotherapy, with radiation completed > 12 weeks prior to C1D1 of therapy, as recommended or appropriate for that CNS tumor type.
Have ≥ 1 site of bi-dimensionally measurable disease (confirmed by magnetic resonance imaging [MRI] and evaluable by RANO criteria), with the size of at least one of the measurable lesions ≥ 1 cm in each dimension and noted on more than one imaging slice.
Imaging study performed within 28 days before enrollment. If on steroid therapy, the dose must be stable for at least 7 days immediately before and during the imaging study.

Must be neurologically stable based on stable neurologic exam for 7 days prior to enrollment.

For subjects eligible for enrollment to bone health cohort, inclusion criterion 3 is modified as the following:

Subjects must have at least one lesion at baseline (measurable or non-measurable as defined by RECIST v1.1 or RANO criteria, as appropriate to tumor type).
Subjects with primary CNS tumors must be neurologically stable based on stable neurologic exam for 7 days prior to enrollment.
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). If neither fresh tissue can be obtained nor archival tissue is available patients might be enrolled after consultation with the sponsor.
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). Subjects who received less than 28 days of treatment and discontinued because of intolerance or toxicity are eligible.
Symptomatic or unstable brain metastases. (Note: Subjects with asymptomatic brain metastases are eligible to participate in the study.) Subjects with primary central nervous system (CNS) tumors are eligible.
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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

204

Study ID:

NCT02576431

Recruitment Status:

Recruiting

Sponsor:

Bayer

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There are 156 Locations for this study

See Locations Near You

Stanford Cancer Center
Palo Alto California, 94304, United States
UCLA-Santa Monica Medical Center
Santa Monica California, 90404, United States
Memorial Hospital West
Pembroke Florida, 33028, United States
University of Chicago
Chicago Illinois, 60637, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Dartmouth Hitchock Medical Center
Lebanon New Hampshire, 03756, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
University of North Carolina Hospitals
Chapel Hill North Carolina, 27599, United States
Wake Forest Baptist Health
Winston-Salem North Carolina, 27157, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Inova Schar Cancer Institute
Fairfax Virginia, 22031, United States
University of Washington
Seattle Washington, 98109, United States
West Virginia University
Morgantown West Virginia, 26505, United States
Centro Medico Austral
Buenos Aires Ciudad Auton. De Buenos Aires, C1019, Argentina
Hospital Británico
Buenos Aires Ciudad Auton. De Buenos Aires, C1280, Argentina
Instituto Medico Especializado Alexander Fleming
Buenos Aires Ciudad Auton. De Buenos Aires, C1426, Argentina
Centro Estudios Médicos e Invest. Clínicas "Dr. N. Quirno"
Buenos Aires Ciudad Auton. De Buenos Aires, C1431, Argentina
Hospital Alemán
Buenos Aires Ciudad Auton. De Buenos Aires, , Argentina
Fundación Cenit para la Investigación en Neurociencias
Caba Ciudad Auton. De Buenos Aires, C1125, Argentina
Instituto de Oncología de Rosario
Rosario Santa Fe, S2000, Argentina
Centro Médico San Roque
San Miguel de Tucumán Tucuman, T4000, Argentina
Macquarie University Hospital
Macquarie University New South Wales, 2109, Australia
Royal Darwin Hospital
Tiwi Northern Territory, 0810, Australia
St John of God Healthcare
Subiaco Western Australia, 6008, Australia
Sir Charles Gairdner Hospital
Nedlands , 6009, Australia
Institut Jules Bordet/Jules Bordet Instituut
Anderlecht , 1070, Belgium
Hosp. Araujo Jorge da Associação de Combate ao Câncer
Goiânia Goiás, 74605, Brazil
Cenantron Centro Avançado de Tratamento Oncológico, Ltda.
Belo Horizonte Minas Gerais, 30110, Brazil
Associação Hospital de Caridade de Ijuí
Ijuí Rio Grande Do Sul, 98700, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre Rio Grande Do Sul, 90050, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos Sao Paulo, 14784, Brazil
Hospital de Base da Fundação F M S J Rio Preto
São José do Rio Preto Sao Paulo, 15090, Brazil
Instituto do Câncer do Estado de São Paulo
São Paulo Sao Paulo, 01246, Brazil
Clín. de Pesq. e Centro de Estudos em Onco Gineco Mamária
São Paulo Sao Paulo, 01317, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo Sao Paulo, 01323, Brazil
IBCC - Instituto Brasileiro de Controle do Cancer
São Paulo Sao Paulo, 04014, Brazil
Instituto Nacional do Câncer - INCA - HC II
Rio de Janeiro , 20220, Brazil
INCA - Hospital do Cancer III
Rio de Janeiro , 20560, Brazil
Oncoclínicas Rio de Janeiro S.A
Rio de Janeiro , 22250, Brazil
Hospital Sirio Libanes
Sao Paulo , 01308, Brazil
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Juravinski Cancer Centre-McMaster Medical Unit
Hamilton Ontario, L8V 5, Canada
London Regional Cancer Program, London Health Sciences Ctr
London Ontario, N6A 5, Canada
Sir Mortimer B. Davis Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Sun Yat-sen University Cancer Center
Guangzhou Guangdong, 51006, China
Sichuan University West China Hospital
Chengdu Sichuan, , China
Beijing Cancer Hospital
Beijing , 10014, China
Zhongshan Hospital, Fudan University
Shanghai , 20003, China
Instituto Nacional de Cancerología INC Colombia
Bogotá Cundinamarca, 11151, Colombia
Oncomédica S.A.
Montería Córdoba, 23000, Colombia
Fundación Oftalmológica de Santander Carlos Ardila Lule
Floridablanca Santander, 68100, Colombia
Masarykuv onkologicky ustav
Brno , 65 65, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultni Nemocnice Olomouc
Olomouc , 779 0, Czechia
Fakultni Thomayerova Nemocnice
Praha 4 , 140 5, Czechia
Finsen Centre
Copenhagen , 2100, Denmark
Hopital Jean Minjoz
Besancon , 25030, France
Institut Bergonié - Unicancer Nouvelle Aquitaine
Bordeaux Cedex , 33076, France
Hôpital Saint André - Bordeaux
Bordeaux , 33000, France
Centre Léon Bérard
Lyon Cedex , 39373, France
Centre Antoine Lacassagne
Nice Cedex 2 , 06102, France
Hôpital Saint Louis
Paris , 75010, France
Hopital Saint Antoine - Paris
Paris , 75012, France
Hôpital de la Pitié-Salpétrière
Paris , 75651, France
Centre Hospitalier Lyon Sud
Pierre Benite , 69495, France
Hôpital de la Milétrie
POITIERS cedex , 86021, France
Hôpital Guillaume et René Laennec - Nantes
Saint Herblain , 44093, France
Institut de Cancérologie de l'Ouest - Saint Herblain
Saint Herblain , 44805, France
ICANS - Institut de Cancérologie de Strasbourg Europe
Strasbourg , 67033, France
Uniklinik Heidelberg / NCT
Heidelberg Baden-Württemberg, 69120, Germany
Heinrich-Heine-Universität Düsseldorf
Düsseldorf Nordrhein-Westfalen, 40225, Germany
Universitätsklinikum Essen
Essen Nordrhein-Westfalen, 45122, Germany
Charité Comprehensive Cancer Center (CCCC)
Berlin , 12203, Germany
AGIOS SAVVAS Anticancer Hospital of Athens
Athens , 115 2, Greece
LAIKO General Hospital of Athens
Athens , 11526, Greece
General Hospital of Athens "ALEXANDRA"
Athens , 11528, Greece
General Oncology Hospital of Kifissia AGIOI ANARGYROI
Kifissia / Athens , 14564, Greece
University General Hospital of Patra
Patra , 26504, Greece
MH Egeszsegugyi Kozpont
Budapest , 1062, Hungary
Orszagos Onkologiai Intezet
Budapest , 1122, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen , 4032, Hungary
Bacs-Kiskun Megyei Korhaz
Kecskemet , 6000, Hungary
All India Institute of Medical Sciences
New Delhi Delhi, 11002, India
Tata Memorial Hospital
Mumbai, Maharashtra, 40001, India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Insti
Mumbai Maharashtra, 40005, India
HCG Manavata Cancer Centre
Nashik Maharashtra, 42200, India
Jawaharlal Institute Of Postgraduate Medical Education and R
Gorimedu Pondicherry, 60500, India
Chittaranjan National Cancer Institute
Kolkata West Bengal, 70002, India
St Vincents University Hospital
Dublin , DUBLI, Ireland
A.O.R.N. San Giuseppe Moscati
Avellino Campania, 83100, Italy
A.O.U. di Bologna Policlinico S.Orsola Malpighi
Bologna Emilia-Romagna, 40138, Italy
A.S.U. Friuli Centrale - A. Regionale Coordinamento Salute
Udine Friuli-Venezia Giulia, 33100, Italy
IRCCS Istituti Fisioterapici Ospitalieri - IFO
Roma Lazio, 00144, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma Lazio, 00168, Italy
IRCCS Ospedale Policlinico San Martino
Genova Liguria, 16132, Italy
Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
Milano Lombardia, 20089, Italy
IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)
Milano Lombardia, 20141, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milano Lombardia, 20162, Italy
Istituto Oncologico Veneto IRCCS (IOV)
Padova Veneto, 35128, Italy
Nagoya University Hospital
Nagoya Aichi, 466-8, Japan
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
Hokkaido University Hospital
Sapporo Hokkaido, 060-8, Japan
The Cancer Institute Hospital of JFCR
Koto-ku Tokyo, 135-8, Japan
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Korea University Anam Hospital
Seoul , 136-7, Korea, Republic of
Radium Hospital Department of Oncology
Oslo , 0379, Norway
Wojskowy Instytut Medyczny
Warszawa , 04-14, Poland
Fundacao Champalimaud
Lisboa , 1400-, Portugal
CHULN - Hospital Santa Maria
Lisboa , 1649-, Portugal
Centro Hospitalar Universitario do Porto
Porto , 4099-, Portugal
IPO Porto
Porto , 4200-, Portugal
Arkhangelsk Clinical Oncology Dispensary
Arkhangelsk , 16304, Russian Federation
Ltd "EVIMED"
Chelyabinsk , 45404, Russian Federation
Republican Clinical Oncology Dispensary Kazan
Kazan , 42002, Russian Federation
Moscow Clinical Scientific Centre n.a.Loginov
Moscow , 11112, Russian Federation
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS
Moscow , 11547, Russian Federation
1st Moscow State Medical University n.a. I.M.Sechenov
Moscow , 11943, Russian Federation
Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen
Moscow , 12528, Russian Federation
City Oncological Hospital #62
Moscow , 14342, Russian Federation
Clinical Diagnostical Center
Nizhny Novgorod , 60300, Russian Federation
St. Petersburg Clinical Onc. Cent. of Spec. Types of Care
St. Petersburg , 19775, Russian Federation
National Cancer Center Singapore
Singapore , 16961, Singapore
Onkologicky Ustav Svatej Alzbety, s.r.o.
Bratislava , 812 5, Slovakia
Narodny onkologicky ustav
Bratislava , 833 1, Slovakia
Institut Català d'Oncologia Hospitalet
Hospitalet de Llobregat Barcelona, 08907, Spain
Hospital Universitario "Marqués de Valdecilla"
Santander Cantabria, 39008, Spain
Hospital del Mar
Barcelona , 08003, Spain
Ciutat Sanitària i Universitaria de la Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona , 08036, Spain
Hospital General Universitario Gregorio Marañón | Oncología
Madrid , 28007, Spain
Fundacion Jimenez Diaz (Clinica de la Concepcion)
Madrid , 28040, Spain
Centro Integral Oncológico Clara Campal
Madrid , 28050, Spain
Hospital Clínico Universitario de Valencia
Valencia , 46010, Spain
Hospital General Universitario de Valencia
Valencia , 46014, Spain
Karolinska Universitetssjukhuset i Solna
Stockholm , 171 7, Sweden
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung , 833, Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan
Tri-Service General Hospital
Taipei , , Taiwan
Ankara Sehir Hastanesi
Ankara , 06800, Turkey
Trakya Univ. Tip Fak.
Edirne , 22030, Turkey
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul , 34093, Turkey
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
Istanbul , 34098, Turkey
TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has
Istanbul , 34724, Turkey
Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma
Izmir , 35360, Turkey
Erciyes Universitesi Tip Fakultesi
Kayseri , 38039, Turkey
National Cancer Institute-Ukraine
Kiev , 03022, Ukraine
Southampton General Hospital
Southampton Hampshire, SO16 , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
Institute Of Cancer-Barts and The London School of Medicine
London , EC1M , United Kingdom
University College Hospital
London , W1T 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

204

Study ID:

NCT02576431

Recruitment Status:

Recruiting

Sponsor:


Bayer

How clear is this clinincal trial information?

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