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AzTrials

Solid Tumors Harboring NTRK FusionPhase 2NAVIGATENCT02576431

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

A Phase 2 study testing BAY2757556 (Larotrectinib, Vitrakvi) in people with Solid Tumors Harboring NTRK Fusion, run by Bayer at 98 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors Harboring NTRK Fusion
What is being tested?
BAY2757556 (Larotrectinib, Vitrakvi)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
98 sitesin 25 countries
Study dates
30 Sep 2015to 29 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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
  • Serum creatinine < 2.0 x ULN OR an estimated glomerular filtration rate ≥ 30 mL/minute using the Cockcroft-Gault formula: (140- age) x body weight (kg) x 0.85 (if female)/serum creatinine (mg/dL) x 72 with either result acceptable for enrollment.
  • 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.

Who cannot join

  • 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.
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  • Myocardial infarction within 3 months of screening.
  • Stroke within 3 months of screening.
  • Inability to discontinue treatment with a strong CYP3A4 inhibitor or inducer
  • Currently recovering from AEs/ ADRs due to previous treatments (excluding alopecia). Inclusion is only advised once the AE/ADR resolves or recovers to baseline or at least to CTCAE grade 1.
  • 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.

Trial locations and contacts

98 sites in 25 countries.

98 sites in 25 countries

United States18 sites

  • Mass General Cancer Center

    Boston, Massachusetts, 02114-2696

  • Dana-Farber Cancer Institute - Oncology Department

    Boston, Massachusetts, 02215

  • UNC Hospitals - UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27514

  • The University of Chicago Medical Center - Hyde Park - Hematology & Oncology

    Chicago, Illinois, 60637

  • Cleveland Clinic - Neurology

    Cleveland, Ohio, 44195

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • The University of Texas MD Anderson Cancer Center - Texas Medical Center

    Houston, Texas, 77030

  • West Virginia University

    Morgantown, West Virginia, 26505

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Memorial Sloan Kettering Cancer Center New York - Main Campus

    New York, New York, 10065

  • Stanford Cancer Center Palo Alto

    Palo Alto, California, 94304

  • Memorial Cancer Institute at West

    Pembroke Pines, Florida, 33026

  • Sidney Kimmel Cancer Center - Jefferson Health

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • UCLA Health Santa Monica Cancer Care

    Santa Monica, California, 90404

  • Fred Hutch Cancer Center - Sloan Clinic 1

    Seattle, Washington, 98109

  • Avera Cancer Institute - Sioux Falls

    Sioux Falls, South Dakota, 57105

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

Brazil10 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos/SP, São Paulo, 14784-400

  • Cenantron Centro Avançado de Tratamento Oncológico, Ltda.

    Belo Horizonte, Minas Gerais, 30130-090

  • Hosp. Araujo Jorge da Associação de Combate ao Câncer

    Goiânia, Goiás, 74605-070

  • Instituto Nacional do Câncer - INCA - HC II

    Rio de Janeiro, Rio de Janeiro, 20081-250

  • INCA - Hospital do Cancer III

    Rio de Janeiro, Rio de Janeiro, 20560-120

  • Oncoclínicas Rio de Janeiro S.A

    Rio de Janeiro, Rio de Janeiro, 22250-905

  • Instituto do Cancer do Estado de Sao Paulo

    São Paulo, São Paulo, 01246-000

  • Real e Benemérita Associação Portuguesa de Beneficência

    São Paulo, São Paulo, 01323-001

  • Hospital Sirio Libanes

    São Paulo, São Paulo, 01409-000

  • IBCC - Instituto Brasileiro de Controle do Cancer

    São Paulo, São Paulo, 03102-002

Other trials in Brazil

France8 sites

  • Hopital Jean Minjoz

    Besançon, 25030

  • Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale

    Bordeaux, 33000

  • Centre Antoine Lacassagne - Departement Oncologie

    Nice, 06100

  • Hopital Saint Antoine APHP - Departement Oncologie

    Paris, 75012

  • APHP-Hopital la Pitie Salpetriere-Departement oncologie

    Paris, 75013

  • Hôpital de la Milétrie

    Poitiers, 86021

  • Institut de Cancerologie Ouest - Saint-Herblain

    Saint-Herblain, 44800

  • ICANS - Institut de Cancerologie de Strasbourg Europe - service oncologie medicale

    Strasbourg, 67200

Other trials in France

Turkey (Türkiye)7 sites

  • Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital

    Ankara, 6800

  • Trakya Univ. Tip Fak.

    Edirne, 22030

  • Istanbul Universitesi Istanbul Tip Fakultesi

    Istanbul, 34093

  • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has

    Istanbul, 34722

  • Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma

    Izmir, 35360

  • Erciyes Universitesi Tip Fakultesi

    Kayseri, 38039

Other trials in Turkey (Türkiye)

Italy6 sites

  • A.O.R.N. San Giuseppe Moscati

    Avellino, Campania, 83100

  • A.O.U. di Bologna Policlinico S.Orsola Malpighi

    Bologna, Emilia-Romagna, 40138

  • Istituto Europeo di Oncologia s.r.l

    Milan, Lombardy, 20141

  • Istituto Oncologico Veneto

    Padova, Veneto, 35128

  • IRCCS Istituti Fisioterapici Ospitalieri - IFO

    Rome, Lazio, 144

  • A.S.U. Friuli Centrale - A. Regionale Coordinamento Salute

    Udine, Friuli Venezia Giulia, 33038

Other trials in Italy

Russia6 sites

  • Arkhangelsk Clinical Oncology Dispensary

    Arkhangelsk, 163045

  • Republican Clinical Oncology Dispensary Kazan

    Kazan', 420029

  • Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS

    Moscow, 115478

  • 1st Moscow State Medical University n.a. I.M.Sechenov

    Moscow, 119991

  • Clinical Diagnostical Center

    Nizhny Novgorod, 603006

  • St. Petersburg Clinical Onc. Cent. of Spec. Types of Care

    Saint Petersburg, 197758

Other trials in Russia

Spain6 sites

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Ciutat Sanitaria i Universitaria de la Vall d'Hebron

    Barcelona, Barcelona, 08035

  • Institut Catala D'oncologia - Oncologia

    Barcelona, L Hospitalet de Llobregat, 8907

  • Hospital General Universitario Gregorio Maranon | Oncologia

    Madrid, Madrid, 28007

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Madrid, 28040

  • Centro Integral Oncológico Clara Campal

    Madrid, Madrid, 28050

Other trials in Spain

Argentina5 sites

  • Hospital Alemán

    Buenos Aires, Ciudad Auton. de Buenos Aires, C11118AAT

  • Centro Estudios Médicos e Invest. Clínicas "Dr. N. Quirno"

    Buenos Aires, Ciudad Auton. de Buenos Aires, TBC

  • Fundación Cenit para la Investigación en Neurociencias

    CABA, Ciudad Auton. de Buenos Aires, C1125 ABD

  • Centro Médico San Roque

    San Miguel de Tucumán, Tucumán Province, T4000HXU

  • Centro Medico Austral

    TBC, Ciudad Auton. de Buenos Aires, C1019ABS

Other trials in Argentina

China4 sites

  • Beijing Cancer Hospital - Oncology Department

    Beijing, Beijing Municipality, 100142

  • Sichuan University West China Hospital

    Chengdu, Sichuan, MISSING

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

  • Zhongshan Hospital, Fudan University - Oncology Department

    Shanghai, 200032

Other trials in China

Japan4 sites

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, 135-8550

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

Other trials in Japan

South Korea4 sites

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 03722

  • Asan Medical Center-Oncology

    Seoul, Seoul Teugbyeolsi, 05505

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 3080

  • Samsung Medical Center - Oncology Department

    Seoul, 06351

Other trials in South Korea

Australia3 sites

  • St John of God Healthcare

    Subiaco, Western Australia, 6008

  • Macquarie University Hospital

    Sydney, New South Wales, 2109

  • Royal Darwin Hospital

    Tiwi, Northern Territory, 810

Other trials in Australia

Colombia3 sites

  • Instituto Nacional de Cancerología INC Colombia

    Bogota, Cundinamarca, 111511

  • Fundación Oftalmológica de Santander Carlos Ardila Lule

    Floridablanca, Santander Department, 681004

  • Oncomédica S.A.

    Montería, Departamento de Córdoba, 230002

Other trials in Colombia

India2 sites

  • All India Institute of Medical Sciences

    Bhubaneswar, Odisha, 751019

  • Jawaharlal Institute Of Postgraduate Medical Education and R

    Gorimedu, Puducherry, 605006

Other trials in India

Slovakia2 sites

  • Onkologicky Ustav Svatej Alzbety, s.r.o.

    Bratislava, 812 50

  • Narodny onkologicky ustav

    Bratislava, 833 10

Other trials in Slovakia

Belgium1 site

  • Institut Jules Bordet/Jules Bordet Instituut

    Brussels, 1070

Other trials in Belgium

Canada1 site

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

Other trials in Canada

Czechia1 site

  • Fakultní Nemocnice Olomouc

    Olomouc, 77900

Other trials in Czechia

Denmark1 site

  • Rigshospitalet - Kræftbehandling

    Copenhagen OE, 2100

Other trials in Denmark

Germany1 site

  • Charité Comprehensive Cancer Center (CCCC)

    Berlin, State of Berlin, 12203

Other trials in Germany

Ireland1 site

  • St Vincents University Hospital

    Dublin, TBC

Other trials in Ireland

Portugal1 site

  • IPO Porto

    Porto, Porto District, 4200-072

Other trials in Portugal

Singapore1 site

  • National Cancer Center Singapore - Oncology Department

    Singapore, 168583

Other trials in Singapore

Sweden1 site

  • Karolinska Universitetssjukhuset Solna - Tema Cancer

    Stockholm, 171 76

Other trials in Sweden

Taiwan1 site

  • Tri-Service General Hospital

    Taipei, 114

Other trials in Taiwan

About this study

Official title: 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

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.

Read the detailed 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.

Being tested
BAY2757556 (Larotrectinib, Vitrakvi)
Keywords
Non-small cell lung cancer, Thyroid cancer, Sarcoma, Colorectal cancer, Salivary gland cancer, Biliary cancer, Central nervous system (CNS) Tumor, Breast cancer, Melanoma, Neurotrophic tyrosine receptor kinase (NTRK), NTRK1, NTRK2, NTRK3, Fusion Positive, TRK fusion, TRKA, TRKB, TRKC, ETV6
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Thyroid Neoplasms, Sarcoma, Colorectal Neoplasms, Salivary Gland Neoplasms, Biliary Tract Neoplasms, Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY2757556 (Larotrectinib, Vitrakvi)Drug

    Also called LOXO-101

    Larotrectinib will be administered orally as capsule or liquid solution at a dose of 100 mg twice daily in continuing 28-days cycles.

Study groups in NCT02576431
Study groupRoleWhat they receive
Arm 1_NSCLCExperimentalPatients with solid non-small cell lung cancer (NSCLC) harboring NTRK fusions (arm closed)
Receives: Drug: BAY2757556 (Larotrectinib, Vitrakvi)
Arm 2_ThyroidExperimentalPatients with solid thyroid tumors harboring NTRK fusions (arm closed)
Receives: Drug: BAY2757556 (Larotrectinib, Vitrakvi)
Arm 3_SarcomaExperimentalPatients with soft-tissue sarcoma harboring NTRK fusions (arm closed)
Receives: Drug: BAY2757556 (Larotrectinib, Vitrakvi)
Arm 4_ColorectalExperimentalPatients with solid colorectal tumors harboring NTRK fusions (arm closed)
Receives: Drug: BAY2757556 (Larotrectinib, Vitrakvi)
Arm 5_SalivaryExperimentalPatients with solid salivary tumors harboring NTRK fusions (arm closed)
Receives: Drug: BAY2757556 (Larotrectinib, Vitrakvi)
Arm 6_BiliaryExperimentalPatients with solid biliary tumors harboring NTRK fusions (arm closed)
Receives: Drug: BAY2757556 (Larotrectinib, Vitrakvi)
Arm 7_Primary CNSExperimentalPatients with solid tumors in the primary central nervous system (CNS) harboring NTRK fusions (arm closed)
Receives: Drug: BAY2757556 (Larotrectinib, Vitrakvi)
Arm 8_Other tumorsExperimentalPatients with e.g. kidney cancer, squamous cell cancer of head or neck or ovarian solid tumors harboring NTRK fusions (arm closed)
Receives: Drug: BAY2757556 (Larotrectinib, Vitrakvi)
Arm 9_Solid tumors without confirmed NTRK fusionExperimentalPatients 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)
Receives: Drug: BAY2757556 (Larotrectinib, Vitrakvi)
Arm 10_Prospective cohortExperimentalPatients 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)
Receives: Drug: BAY2757556 (Larotrectinib, Vitrakvi)
Arm 11_Bone health cohortExperimentalPatients with all tumor types harboring NTRK fusions, not eligible for the main prospective cohort, including patients with non-measurable disease
Receives: Drug: BAY2757556 (Larotrectinib, Vitrakvi)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 120 months

Secondary outcomes (11)

  1. 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

    Measured: Up to 120 months

  2. 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

    Duration 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).

    Measured: Up to 120 months

  3. Clinical benefit rate (CBR): best overall response of confirmed CR, PR, or stable disease lasting 16 or more weeks following the initiation of Larotrectinib

    Measured: Up to 120 months

  4. Rate of subjects that have any tumor regression as a best response, measured as shrinkage of target lesions

    Measured: Up to 120 months

  5. PFS: Number of months from initiation of larotrectinib to the earlier of disease progression or death due to any cause

    Measured: Up to 120 months

  6. Overall Survival (OS): Number of months from the initiation of larotrectinib to the date of death due to any cause.

    Measured: Up to 120 months

  7. Comparison of PFS following initiation of larotrectinib to that following the line of therapy immediately preceding larotrectinib in each subject who has received prior therapy

    Measured: Up to 120 months

  8. Number of subjects with AEs categorized by severity. (including all, serious, and those considered treatment related.)

    Measured: Up to 120 months

  9. Number of subjects with safety-relevant changes in clinical parameters or vital signs after drug administration

    Measured: Up to 120 months

  10. Severity of safety-relevant changes in clinical parameters or vital signs after drug administration

    Measured: Up to 120 months

  11. Concordance coefficient

    Concordance of prior molecular profiling that detected an NTRK fusion within the subject's tumor with the diagnostic test being evaluated by the Sponsor.

    Measured: Up to 120 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2015 (estimated)
  2. Study start30 Sep 2015
  3. Primary completion29 Sep 2025
  4. Study completion29 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02576431
Sponsor's protocol ID
20289
Other IDs
LOXO-TRK-15002, 2022-502667-38-00, 2015-003582-28, 2015
Acronym
NAVIGATE
Status last verified
Jun 2026
First submitted
12 Oct 2015
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.
Expanded access
Available

Publications

  • Waguespack SG, Drilon A, Lin JJ, Brose MS, McDermott R, Almubarak M, Bauman J, Casanova M, Krishnamurthy A, Kummar S, Leyvraz S, Oh DY, Park K, Sohal D, Sherman E, Norenberg R, Silvertown JD, Brega N, Hong DS, Cabanillas ME. Efficacy and safety of larotrectinib in patients with TRK fusion-positive thyroid carcinoma. Eur J Endocrinol. 2022 Apr 29;186(6):631-643. doi: 10.1530/EJE-21-1259.

    PubMed 35333737

  • Mascarenhas L, Ollis C, Singh Y, Menachery L, Burcoveanu DI, De La Cuesta E, van Tilburg CM, Laetsch TW. Cancer control after pausing treatment with larotrectinib in responding children with sarcoma and a TRK fusion: a plain language summary. Future Oncol. 2026 Aug 19:1-10. doi: 10.1080/14796694.2026.2711519. Online ahead of print.

    PubMed 42614029

  • Ajani JA, D'Amico TA, Bentrem DJ, Corvera CU, Das P, Enzinger PC, Enzler T, Gerdes H, Gibson MK, Grierson P, Gupta G, Hofstetter WL, Ilson DH, Jalal S, Kim S, Kleinberg LR, Klempner S, Lacy J, Lee B, Licciardi F, Lloyd S, Ly QP, Matsukuma K, McNamara M, Merkow RP, Miller AM, Mukherjee S, Mulcahy MF, Perry KA, Pimiento JM, Reddi DM, Reznik S, Roses RE, Strong VE, Su S, Uboha N, Wainberg ZA, Willett CG, Woo Y, Yoon HH, McMillian NR, Stein M. Gastric Cancer, Version 2.2025, NCCN Clinical Practice Guidelines In Oncology. J Natl Compr Canc Netw. 2025 May;23(5):169-191. doi: 10.6004/jnccn.2025.0022.

    PubMed 40341199

  • Brose MS, Westphalen CB, Pan X, Bernard-Gauthier V, Kurtinecz M, Guo H, Aris V, Brett NR, Majdi A, Subbiah V, Pennell NA, Kehl KL, Drilon A. Larotrectinib Compared With Real-World Non-Tropomyosin Receptor Kinase Inhibitor Therapies in Patients With Tropomyosin Receptor Kinase Fusion Cancer. JCO Precis Oncol. 2025 Apr;9:e2400500. doi: 10.1200/PO-24-00500. Epub 2025 Apr 23.

    PubMed 40267388

  • Mascarenhas L, DuBois SG, Albert CM, Bielack S, Orbach D, Federman N, Geoerger B, Nagasubramanian R, Zhang Y, Chisholm J, Gallego Melcon S, Goto H, Morgenstern DA, Owens C, Pappo AS, Perreault S, Schulte JH, Shukla N, Zwaan CM, Neu N, Bernard-Gauthier V, De La Cuesta E, van Tilburg CM, Laetsch TW. Elective Discontinuation of Larotrectinib in Pediatric Patients With TRK Fusion Sarcomas and Related Mesenchymal Tumors. J Clin Oncol. 2025 Apr;43(10):1180-1187. doi: 10.1200/JCO.24.00848. Epub 2025 Jan 27.

    PubMed 39869835

  • Hsieh CY, Hsu FL, Tsai TF. Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2607-2620. doi: 10.1007/s13555-024-01229-6. Epub 2024 Jul 29.

    PubMed 39073712

  • Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7.

    PubMed 37934000

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Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY2757556 (Larotrectinib, Vitrakvi) in people with Solid Tumors Harboring NTRK Fusion, run by Bayer at 98 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in United States, Brazil, France, Turkey (Türkiye), Italy and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Up to 120 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02576431, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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