Trial Condition(s):
Solid tumors harboring NTRK fusion
A study to test the effect of the drug larotrectinib in adults and children with NTRK-fusion positive solid tumors (NAVIGATE)
Bayer Identifier:
20289
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial 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.
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 a. 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. b. 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. c. 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. d. 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: e. 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). f. 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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Institut Bergonié - Unicancer Nouvelle Aquitaine BORDEAUX CEDEX, France, 33076 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Finsen Centre Copenhagen, Denmark, 2100 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Center Hospital East Kashiwa, Japan, 277-8577 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UCLA-Santa Monica Medical Center Santa Monica, United States, 90404 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Texas MD Anderson Cancer Center Houston, United States, 77030 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Massachusetts General Hospital Boston, United States, 02114 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vanderbilt University Medical Center Nashville, United States, 37232 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Memorial Sloan-Kettering Cancer Center New York, United States, 10065 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inova Schar Cancer Institute Fairfax, United States, 22031 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fox Chase Cancer Center Philadelphia, United States, 19111 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Thomas Jefferson University Philadelphia, United States, 19107 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cleveland Clinic Foundation Cleveland, United States, 44195-0002 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of North Carolina Hospitals Chapel Hill, United States, 27599 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations West Virginia University Morgantown, United States, 26505 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wake Forest Baptist Health Winston-Salem, United States, 27157-1082 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Memorial Hospital West Pembroke, United States, 33028 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Avera Cancer Institute Sioux Falls, United States, 57105 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dana-Farber Cancer Institute Boston, United States, 02215 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Washington Seattle, United States, 98109 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institute Of Cancer-Barts and The London School of Medicine London, United Kingdom, EC1M 6BQ | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University College Hospital London, United Kingdom, W1T 7HA | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Chicago Chicago, United States, 60637 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St Vincents University Hospital Dublin, Ireland, DUBLIN 4 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stanford Cancer Center Palo Alto, United States, 94304 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sun Yat-sen University Cancer Center Guangzhou, China, 510060 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zhongshan Hospital, Fudan University Shanghai, China, 200032 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sichuan University West China Hospital Chengdu, China | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Cancer Hospital Beijing, China, 100142 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charité Comprehensive Cancer Center (CCCC) Berlin, Germany, 12203 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona, Spain, 08023 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Integral Oncológico Clara Campal Madrid, Spain, 28050 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundacion Jimenez Diaz (Clinica de la Concepcion) Madrid, Spain, 28040 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IPO Porto Porto, Portugal, 4200-072 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Samsung Medical Center Seoul, South Korea, 06351 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, South Korea, 03080 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Severance Hospital, Yonsei University Health System Seoul, South Korea, 03722 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Center Singapore Singapore, Singapore, 169610 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagoya University Hospital Nagoya, Japan, 466-8560 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Cancer Institute Hospital of JFCR Koto-ku, Japan, 135-8550 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hokkaido University Hospital Sapporo, Japan, 060-8648 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General Universitario de Valencia Valencia, Spain, 46014 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario "Marqués de Valdecilla" Santander, Spain, 39008 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 100 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chang Gung Memorial Hospital Kaohsiung Kaohsiung, Taiwan, China, 833 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tri-Service General Hospital Taipei, Taiwan, China | Status Recruiting | Contact Us: E-mail: clinical-trials-con[email protected] Phone: (+)1-888-84 22937 |
Locations Asan Medical Center Seoul, South Korea, 05505 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital del Mar Barcelona, Spain, 08003 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General Universitario Gregorio Marañón | Oncología Madrid, Spain, 28007 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Istituto Europeo di Oncologia s.r.l. (IEO) Milano, Italy, 20141 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Bologna Policlinico S.Orsola Malpighi Bologna, Italy, 40138 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.S.U. Friuli Centrale - A. Regionale Coordinamento Salute Udine, Italy, 33100 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. Milano, Italy, 20089 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istituto Oncologico Veneto IRCCS (IOV) Padova, Italy, 35128 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.R.N. San Giuseppe Moscati Avellino, Italy, 83100 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma, Italy, 00168 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre, Brazil, 90050-170 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen Moscow, Russia, 125284 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ltd "EVIMED" Chelyabinsk, Russia, 454048 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Arkhangelsk Clinical Oncology Dispensary Arkhangelsk, Russia, 163045 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Oncological Hospital #62 Moscow, Russia, 143423 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Diagnostical Center Nizhny Novgorod, Russia, 603006 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations 1st Moscow State Medical University n.a. I.M.Sechenov Moscow, Russia, 119435 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Korea University Anam Hospital Seoul, South Korea, 136-705 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Narodny onkologicky ustav Bratislava, Slovakia, 833 10 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de Base da Fundação F M S J Rio Preto São José do Rio Preto, Brazil, 15090-000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Karolinska Universitetssjukhuset i Solna Stockholm, Sweden, 171 76 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wojskowy Instytut Medyczny Warszawa, Poland, 04-141 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni Thomayerova Nemocnice Praha 4, Czech Republic, 140 59 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni Nemocnice Olomouc Olomouc, Czech Republic, 77900 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Masarykuv onkologicky ustav Brno, Czech Republic, 65 653 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni Nemocnice Hradec Kralove Hradec Kralove, Czech Republic, 500 05 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Orszagos Onkologiai Intezet Budapest, Hungary, 1122 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital de la Milétrie POITIERS cedex, France, 86021 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Antoine Lacassagne NICE CEDEX 2, France, 06102 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beatson West of Scotland Cancer Centre Glasgow, United Kingdom, G12 0YN | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Macquarie University Hospital Macquarie University, Australia, 2109 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St John of God Healthcare Subiaco, Australia, 6008 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Darwin Hospital Tiwi, Australia, 0810 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Saint Antoine - Paris PARIS, France, 75012 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital de la Pitié-Salpétrière PARIS, France, 75651 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Lyon Sud PIERRE BENITE, France, 69495 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Grande Ospedale Metropolitano Niguarda Milano, Italy, 20162 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Ospedale Policlinico San Martino Genova, Italy, 16132 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Guillaume et René Laennec - Nantes Saint Herblain, France, 44093 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Jean Minjoz BESANCON, France, 25030 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Trakya Univ. Tip Fak. Edirne, Turkey, 22030 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi Istanbul, Turkey, 34098 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Izmir, Turkey, 35360 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital Ankara, Turkey, 6800 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Erciyes Universitesi Tip Fakultesi Kayseri, Turkey, 38039 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istanbul Universitesi Istanbul Tip Fakultesi Istanbul, Turkey, 34093 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut de Cancérologie de l'Ouest - Saint Herblain Saint-Herblain, France, 44800 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Saint Louis PARIS, France, 75010 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ICANS - Institut de Cancérologie de Strasbourg Europe STRASBOURG, France, 67033 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Associação Hospital de Caridade de Ijuí Ijuí, Brazil, 98700-000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IBCC - Instituto Brasileiro de Controle do Cancer São Paulo, Brazil, 04014-002 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hosp. Araujo Jorge da Associação de Combate ao Câncer Goiânia, Brazil, 74605-070 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clín. de Pesq. e Centro de Estudos em Onco Gineco Mamária São Paulo, Brazil, 01317-000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cenantron Centro Avançado de Tratamento Oncológico, Ltda. Belo Horizonte, Brazil, 30110-090 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations INCA - Hospital do Cancer III Rio de Janeiro, Brazil, 20560-121 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundação Pio XII – Hospital de Câncer de Barretos Barretos, Brazil, 14784-400 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto do Câncer do Estado de São Paulo São Paulo, Brazil, 01246-000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Sirio Libanes Sao Paulo, Brazil, 01308-050 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto Nacional do Câncer - INCA - HC II Rio de Janeiro, Brazil, 20220-410 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oncoclínicas Rio de Janeiro S.A Rio de Janeiro, Brazil, 22250-905 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Real e Benemérita Associação Portuguesa de Beneficência São Paulo, Brazil, 01323-001 | Status Recruiting | Contact Us: E-mail: clini[email protected] Phone: (+)1-888-84 22937 |
Locations TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has ISTANBUL, Turkey, 34724 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto Nacional de Cancerología INC Colombia Bogotá, Colombia, 111511 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundación Oftalmológica de Santander Carlos Ardila Lule Floridablanca, Colombia, 681004 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oncomédica S.A. Montería, Colombia, 230002 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Radium Hospital Department of Oncology Oslo, Norway, 0379 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto de Oncología de Rosario Rosario, Argentina, S2000KZE | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Alemán Buenos Aires, Argentina | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MH Egeszsegugyi Kozpont Budapest, Hungary, 1062 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Debreceni Egyetem Klinikai Kozpont Debrecen, Hungary, 4032 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bacs-Kiskun Megyei Korhaz Kecskemet, Hungary, 6000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Saint André - Bordeaux BORDEAUX, France, 33000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Petersburg Clinical Onc. Cent. of Spec. Types of Care St. Petersburg, Russia, 197758 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Republican Clinical Oncology Dispensary Kazan Kazan, Russia, 420029 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundacao Champalimaud Lisboa, Portugal, 1400-038 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHULN - Hospital Santa Maria Lisboa, Portugal, 1649-035 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations General Oncology Hospital of Kifissia AGIOI ANARGYROI Kifissia / Athens, Greece, 14564 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LAIKO General Hospital of Athens Athens, Greece, 11526 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AGIOS SAVVAS Anticancer Hospital of Athens Athens, Greece, 115 22 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations General Hospital of Athens "ALEXANDRA" Athens, Greece, 11528 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Patra Patra, Greece, 26504 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations London Regional Cancer Program, London Health Sciences Ctr London, Canada, N6A 5W9 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tom Baker Cancer Centre Calgary, Canada, T2N 4N2 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Juravinski Cancer Centre-McMaster Medical Unit Hamilton, Canada, L8V 5C2 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Català d'Oncologia Hospitalet Hospitalet de Llobregat, Spain, 08907 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tata Memorial Hospital Mumbai,, India, 400012 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kokilaben Dhirubhai Ambani Hospital & Medical Research Insti Mumbai, India, 400053 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations All India Institute of Medical Sciences New Delhi, India, 110029 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jawaharlal Institute Of Postgraduate Medical Education and R Gorimedu, India, 605006 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Istituti Fisioterapici Ospitalieri - IFO Roma, Italy, 00144 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Léon Bérard LYON CEDEX, France, 39373 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniklinik Heidelberg / NCT Heidelberg, Germany, 69120 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HCG Manavata Cancer Centre Nashik, India, 422002 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chittaranjan National Cancer Institute Kolkata, India, 700026 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A phase 2 basket study of the oral TRK inhibitor larotrectinib in subjects with NTRK fusion-positive tumors
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
11
Primary Outcome
- Best overall response rate by IRCProportion of subjects with either complete response or partial response as determined by an independent radiology committee (IRC) using RECIST or RANO criteria.Timeframe: Up to 120 months
Secondary Outcome
- Best overall response rate by investigatorProportion of subjects with either complete response or partial response as determined by the treating investigator using RECIST or RANO criteria.Timeframe: Up to 120 months
- Duration of response (DOR) by IRCDuration of response is the number of months from the start of confirmed complete response or partial response to disease progression or death. Complete response, partial response and disease progression are assessed by an independent radiology committee (IRC).Timeframe: Up to 120 months
- Duration of response (DOR) by investigatorDuration of response is the number of months from the start of confirmed complete response or partial response to disease progression or death. Complete response, partial response and disease progression are assessed by the treating investigator.Timeframe: Up to 120 months
- Clinical benefit rate (CBR)Proportion of subjects with best overall response of complete response, partial response or stable disease lasting 16 or more weeks following the initiation of larotrectinib.Timeframe: Up to 120 months
- Progression-free survival (PFS) after LarotrectinibNumber of months from initiation of larotrectinib to either disease progression or death due to any cause.Timeframe: Up to 120 months
- Overall survival timeNumber of months from the initiation of larotrectinib to the date of death due to any cause.Timeframe: Up to 120 months
- Progression-free survival (PFS) after past cancer therapyNumber of months from initiation of the line of therapy preceding larotrectinib to either disease progression or death due to any cause.Timeframe: Up to 120 months
- Number of subjects with adverse eventsTimeframe: Up to 120 months
- Number of subjects with serious adverse eventsTimeframe: Up to 120 months
- Number of subjects with treatment-related adverse eventsTimeframe: Up to 120 months
- Severity of adverse eventsTimeframe: Up to 120 months
- Severity of serious adverse eventsTimeframe: Up to 120 months
- Severity of treatment-related adverse eventsTimeframe: Up to 120 months
- Duration of adverse eventsTimeframe: Up to 120 months
- Duration of serious adverse eventsTimeframe: Up to 120 months
- Duration of treatment-related adverse eventsTimeframe: Up to 120 months
- Number of subjects with safety-relevant changes in clinical parameters or vital signs after drug administrationTimeframe: Up to 120 months
- Severity of safety-relevant changes in clinical parameters or vital signs after drug administrationTimeframe: Up to 120 months
- Proportion of patients with any tumor regression (i.e., measured as shrinkage of target lesions) as a best responseTimeframe: Up to 120 months
- Concordance coefficientConcordance of prior molecular profiling that detected an NTRK fusion within the subject’s tumor with the diagnostic test being evaluated by the SponsorTimeframe: Up to 120 months
Additional Information
Not Available
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