A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors
NAVIGATE
A Study to Learn How Well the Drug Larotrectinib Works in Adults With Different Solid Cancers With a Change in the Genes Called NTRK Fusion
4 other identifiers
interventional
215
25 countries
98
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2015
Longer than P75 for phase_2
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2015
CompletedFirst Submitted
Initial submission to the registry
October 12, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2025
CompletedApril 28, 2026
April 1, 2026
10 years
October 12, 2015
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best overall response of confirmed complete response (CR) or partial response (PR) as determined by an independent radiology review committee using RECIST v1.1 or RANO criteria, as appropriate to tumor type.
Up to 120 months
Secondary Outcomes (11)
Best overall response of confirmed CR or PR as determined by the treating Investigator using RECIST v1.1 or RANO criteria, as appropriate to tumor type
Up to 120 months
Duration of response (DOR): determined for subjects with best overall response of confirmed CR or PR by 1) an independent radiology review committee and 2) the treating Investigator
Up to 120 months
Clinical benefit rate (CBR): best overall response of confirmed CR, PR, or stable disease lasting 16 or more weeks following the initiation of Larotrectinib
Up to 120 months
Rate of subjects that have any tumor regression as a best response, measured as shrinkage of target lesions
Up to 120 months
PFS: Number of months from initiation of larotrectinib to the earlier of disease progression or death due to any cause
Up to 120 months
- +6 more secondary outcomes
Study Arms (11)
Arm 1_NSCLC
EXPERIMENTALPatients with solid non-small cell lung cancer (NSCLC) harboring NTRK fusions (arm closed)
Arm 2_Thyroid
EXPERIMENTALPatients with solid thyroid tumors harboring NTRK fusions (arm closed)
Arm 3_Sarcoma
EXPERIMENTALPatients with soft-tissue sarcoma harboring NTRK fusions (arm closed)
Arm 4_Colorectal
EXPERIMENTALPatients with solid colorectal tumors harboring NTRK fusions (arm closed)
Arm 5_Salivary
EXPERIMENTALPatients with solid salivary tumors harboring NTRK fusions (arm closed)
Arm 6_Biliary
EXPERIMENTALPatients with solid biliary tumors harboring NTRK fusions (arm closed)
Arm 7_Primary CNS
EXPERIMENTALPatients with solid tumors in the primary central nervous system (CNS) harboring NTRK fusions (arm closed)
Arm 8_Other tumors
EXPERIMENTALPatients with e.g. kidney cancer, squamous cell cancer of head or neck or ovarian solid tumors harboring NTRK fusions (arm closed)
Arm 9_Solid tumors without confirmed NTRK fusion
EXPERIMENTALPatients 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)
Arm 10_Prospective cohort
EXPERIMENTALPatients 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)
Arm 11_Bone health cohort
EXPERIMENTALPatients with all tumor types harboring NTRK fusions, not eligible for the main prospective cohort, including patients with non-measurable disease
Interventions
Larotrectinib will be administered orally as capsule or liquid solution at a dose of 100 mg twice daily in continuing 28-days cycles.
Eligibility Criteria
You may qualify if:
- 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. Subjects who have an NTRK gene fusion identified in a lab where CLIA or equivalent certification cannot be confirmed by the Sponsor at the time of consent may have been enrolled in Cohort 9 as per protocol versions 1.0 - 8.0. From protocol version 9.0: CLIA or similar certification of the lab performing the fusion assay is required. However, patients may be included after discussion with the sponsor if the lab performing the fusion assay is not CLIA or similar certified.
- 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. 2009). 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.
- 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.
- At least 18 years of age
- 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.
- Adequate organ function as defined by the following criteria:
- Serum AST and serum ALT \< 2.5 x upper limit of normal (ULN), or AST and ALT \< 5 x ULN if liver function abnormalities are due to underlying malignancy
- Total bilirubin \< 2.5 x ULN, except in the setting of biliary obstruction. Subjects with a known history of Gilberts Disease and an isolated elevation of indirect bilirubin are eligible
- +4 more criteria
You may not qualify if:
- 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. 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 CNS tumors are eligible.
- Uncontrolled concurrent malignancy that would limit assessment of efficacy of larotrectinib. Allowed conditions may include, but are not limited to in situ cancers of cervix, breast, or skin, superficial bladder cancer, limited-stage prostate cancer, and basal or squamous cancers of the skin.
- 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. 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.
- Inability to discontinue treatment with a strong CYP3A4 inhibitor or inducer
- Known or suspected hypersensitivity against the active substance or any of the ingredients of the IMP.
- Known history of HIV infection. All patients must be screened for HIV up to 28 days prior to study drug start using a blood test for HIV according to local regulations.
- HBV or HCV infection. All patients must be screened for HBV and HCV up to 28 days prior to study drug start using the routine hepatitis virus laboratorial panel. Patients positive for HBsAg or HBcAb will be eligible if they are negative for HBVDNA. Patients positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (98)
Stanford Cancer Center Palo Alto
Palo Alto, California, 94304, United States
UCLA Health Santa Monica Cancer Care
Santa Monica, California, 90404, United States
Memorial Cancer Institute at West
Pembroke Pines, Florida, 33026, United States
The University of Chicago Medical Center - Hyde Park - Hematology & Oncology
Chicago, Illinois, 60637, United States
Mass General Cancer Center
Boston, Massachusetts, 02114-2696, United States
Dana-Farber Cancer Institute - Oncology Department
Boston, Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center New York - Main Campus
New York, New York, 10065, United States
UNC Hospitals - UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic - Neurology
Cleveland, Ohio, 44195, United States
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Avera Cancer Institute - Sioux Falls
Sioux Falls, South Dakota, 57105, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
The University of Texas MD Anderson Cancer Center - Texas Medical Center
Houston, Texas, 77030, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Fred Hutch Cancer Center - Sloan Clinic 1
Seattle, Washington, 98109, United States
West Virginia University
Morgantown, West Virginia, 26505, United States
Hospital Alemán
Buenos Aires, Ciudad Auton. de Buenos Aires, C11118AAT, Argentina
Centro Estudios Médicos e Invest. Clínicas "Dr. N. Quirno"
Buenos Aires, Ciudad Auton. de Buenos Aires, TBC, Argentina
Fundación Cenit para la Investigación en Neurociencias
CABA, Ciudad Auton. de Buenos Aires, C1125 ABD, Argentina
Centro Medico Austral
TBC, Ciudad Auton. de Buenos Aires, C1019ABS, Argentina
Centro Médico San Roque
San Miguel de Tucumán, Tucumán Province, T4000HXU, Argentina
Macquarie University Hospital
Sydney, New South Wales, 2109, Australia
Royal Darwin Hospital
Tiwi, Northern Territory, 810, Australia
St John of God Healthcare
Subiaco, Western Australia, 6008, Australia
Institut Jules Bordet/Jules Bordet Instituut
Brussels, 1070, Belgium
Hosp. Araujo Jorge da Associação de Combate ao Câncer
Goiânia, Goiás, 74605-070, Brazil
Cenantron Centro Avançado de Tratamento Oncológico, Ltda.
Belo Horizonte, Minas Gerais, 30130-090, Brazil
Instituto Nacional do Câncer - INCA - HC II
Rio de Janeiro, Rio de Janeiro, 20081-250, Brazil
INCA - Hospital do Cancer III
Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil
Oncoclínicas Rio de Janeiro S.A
Rio de Janeiro, Rio de Janeiro, 22250-905, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos/SP, São Paulo, 14784-400, Brazil
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, 01246-000, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, São Paulo, 01323-001, Brazil
Hospital Sirio Libanes
São Paulo, São Paulo, 01409-000, Brazil
IBCC - Instituto Brasileiro de Controle do Cancer
São Paulo, São Paulo, 03102-002, Brazil
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Beijing Cancer Hospital - Oncology Department
Beijing, Beijing Municipality, 100142, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
Sichuan University West China Hospital
Chengdu, Sichuan, MISSING, China
Zhongshan Hospital, Fudan University - Oncology Department
Shanghai, 200032, China
Instituto Nacional de Cancerología INC Colombia
Bogota, Cundinamarca, 111511, Colombia
Oncomédica S.A.
Montería, Departamento de Córdoba, 230002, Colombia
Fundación Oftalmológica de Santander Carlos Ardila Lule
Floridablanca, Santander Department, 681004, Colombia
Fakultní Nemocnice Olomouc
Olomouc, 77900, Czechia
Rigshospitalet - Kræftbehandling
Copenhagen OE, 2100, Denmark
Hopital Jean Minjoz
Besançon, 25030, France
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
Bordeaux, 33000, France
Centre Antoine Lacassagne - Departement Oncologie
Nice, 06100, France
Hopital Saint Antoine APHP - Departement Oncologie
Paris, 75012, France
APHP-Hopital la Pitie Salpetriere-Departement oncologie
Paris, 75013, France
Hôpital de la Milétrie
Poitiers, 86021, France
Institut de Cancerologie Ouest - Saint-Herblain
Saint-Herblain, 44800, France
ICANS - Institut de Cancerologie de Strasbourg Europe - service oncologie medicale
Strasbourg, 67200, France
Charité Comprehensive Cancer Center (CCCC)
Berlin, State of Berlin, 12203, Germany
All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019, India
Jawaharlal Institute Of Postgraduate Medical Education and R
Gorimedu, Puducherry, 605006, India
St Vincents University Hospital
Dublin, TBC, 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, 33038, Italy
IRCCS Istituti Fisioterapici Ospitalieri - IFO
Rome, Lazio, 144, Italy
Istituto Europeo di Oncologia s.r.l
Milan, Lombardy, 20141, Italy
Istituto Oncologico Veneto
Padova, Veneto, 35128, Italy
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550, Japan
IPO Porto
Porto, Porto District, 4200-072, Portugal
Arkhangelsk Clinical Oncology Dispensary
Arkhangelsk, 163045, Russia
Republican Clinical Oncology Dispensary Kazan
Kazan', 420029, Russia
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS
Moscow, 115478, Russia
1st Moscow State Medical University n.a. I.M.Sechenov
Moscow, 119991, Russia
Clinical Diagnostical Center
Nizhny Novgorod, 603006, Russia
St. Petersburg Clinical Onc. Cent. of Spec. Types of Care
Saint Petersburg, 197758, Russia
National Cancer Center Singapore - Oncology Department
Singapore, 168583, Singapore
Onkologicky Ustav Svatej Alzbety, s.r.o.
Bratislava, 812 50, Slovakia
Narodny onkologicky ustav
Bratislava, 833 10, Slovakia
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Asan Medical Center-Oncololy
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 3080, South Korea
Samsung Medical Center - Oncology Department
Seoul, 06351, South Korea
Hospital del Mar
Barcelona, Barcelona, 08003, Spain
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
Barcelona, Barcelona, 08035, Spain
Institut Catala D'oncologia - Oncologia
Barcelona, L Hospitalet de Llobregat, 8907, Spain
Hospital General Universitario Gregorio Maranon | Oncologia
Madrid, Madrid, 28007, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Madrid, 28040, Spain
Centro Integral Oncológico Clara Campal
Madrid, Madrid, 28050, Spain
Karolinska Universitetssjukhuset Solna - Tema Cancer
Stockholm, 171 76, Sweden
Tri-Service General Hospital
Taipei, 114, Taiwan
Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital
Ankara, 6800, Turkey (Türkiye)
Trakya Univ. Tip Fak.
Edirne, 22030, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has
Istanbul, 34722, Turkey (Türkiye)
Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma
Izmir, 35360, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi
Kayseri, 38039, Turkey (Türkiye)
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 12, 2015
First Posted
October 15, 2015
Study Start
September 30, 2015
Primary Completion
September 29, 2025
Study Completion
September 29, 2025
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.