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New drug shrinks tumors in patients with rare gene mutation

NCT ID NCT02576431

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 3 times

Summary

This study tested the drug larotrectinib in 215 adults with various solid cancers that have a specific change in the NTRK gene. The drug is taken orally and works by blocking the action of the altered gene. The main goal was to see how many patients had their tumors shrink or disappear.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
larotrectinib (Vitrakvi)
What this could lead to
If successful, this could provide a targeted treatment option for people with various cancers that have an NTRK gene fusion.
What could go wrong
This is a Phase 2 trial, so results are not yet definitive. The drug may not work for all tumor types, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

215 people

The number who actually took part.

Started

Sep 2015

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene fusion, identified through molecular assays as routinely performed at CLIA or other similarly-certified laboratories. 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: 1. 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. 2. 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. 3. 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. 4. 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: 5. 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). 6. 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: 1. 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 2. 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 3. 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. Exclusion Criteria: * Investigational agent or anticancer therapy within 2 weeks prior to the planned start of larotrectinib or 5 half-lives, whichever is shorter, and without recovery of acute and/or clinically significant toxicities from that therapy. * Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK. 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: 1. In adults, persistently uncontrolled hypertension defined as systolic blood pressure (BP) \> 150 mmHg and/or diastolic BP \> 100 mmHg despite antihypertensive therapy. 2. Myocardial infarction within 3 months of screening. 3. 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.

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Conditions

The condition(s) this trial relates to.

Biliary Tract Neoplasms breast neoplasm colorectal neoplasm melanoma neoplasm non-small cell lung carcinoma NTRK fusion positive cancer salivary gland cancer sarcoma Thyroid Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumors harboring NTRK fusion

Contacts and locations

Locations

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

    Moscow, 119991, Russia

  • 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

  • APHP-Hopital la Pitie Salpetriere-Departement oncologie

    Paris, 75013, France

  • All India Institute of Medical Sciences

    Bhubaneswar, Odisha, 751019, India

  • Arkhangelsk Clinical Oncology Dispensary

    Arkhangelsk, 163045, Russia

  • Asan Medical Center-Oncology

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Avera Cancer Institute - Sioux Falls

    Sioux Falls, South Dakota, 57105, United States

  • Beijing Cancer Hospital - Oncology Department

    Beijing, Beijing Municipality, 100142, China

  • Cenantron Centro Avançado de Tratamento Oncológico, Ltda.

    Belo Horizonte, Minas Gerais, 30130-090, Brazil

  • Centre Antoine Lacassagne - Departement Oncologie

    Nice, 06100, France

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

    Buenos Aires, Ciudad Auton. de Buenos Aires, TBC, Argentina

  • Centro Integral Oncológico Clara Campal

    Madrid, Madrid, 28050, Spain

  • Centro Medico Austral

    TBC, Ciudad Auton. de Buenos Aires, C1019ABS, Argentina

  • Centro Médico San Roque

    San Miguel de Tucumán, Tucumán Province, T4000HXU, Argentina

  • Charité Comprehensive Cancer Center (CCCC)

    Berlin, State of Berlin, 12203, Germany

  • Ciutat Sanitaria i Universitaria de la Vall d'Hebron

    Barcelona, Barcelona, 08035, Spain

  • Cleveland Clinic - Neurology

    Cleveland, Ohio, 44195, United States

  • Clinical Diagnostical Center

    Nizhny Novgorod, 603006, Russia

  • Dana-Farber Cancer Institute - Oncology Department

    Boston, Massachusetts, 02215, United States

  • Erciyes Universitesi Tip Fakultesi

    Kayseri, 38039, Turkey (Türkiye)

  • Fakultní Nemocnice Olomouc

    Olomouc, 77900, Czechia

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutch Cancer Center - Sloan Clinic 1

    Seattle, Washington, 98109, United States

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos/SP, São Paulo, 14784-400, Brazil

  • Fundación Cenit para la Investigación en Neurociencias

    CABA, Ciudad Auton. de Buenos Aires, C1125 ABD, Argentina

  • Fundación Oftalmológica de Santander Carlos Ardila Lule

    Floridablanca, Santander Department, 681004, Colombia

  • Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital

    Ankara, 6800, Turkey (Türkiye)

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Hopital Jean Minjoz

    Besançon, 25030, France

  • Hopital Saint Antoine APHP - Departement Oncologie

    Paris, 75012, France

  • Hosp. Araujo Jorge da Associação de Combate ao Câncer

    Goiânia, Goiás, 74605-070, Brazil

  • Hospital Alemán

    Buenos Aires, Ciudad Auton. de Buenos Aires, C11118AAT, Argentina

  • Hospital General Universitario Gregorio Maranon | Oncologia

    Madrid, Madrid, 28007, Spain

  • Hospital Sirio Libanes

    São Paulo, São Paulo, 01409-000, Brazil

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Madrid, 28040, Spain

  • Hospital del Mar

    Barcelona, Barcelona, 08003, Spain

  • Hôpital de la Milétrie

    Poitiers, 86021, France

  • IBCC - Instituto Brasileiro de Controle do Cancer

    São Paulo, São Paulo, 03102-002, Brazil

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

    Strasbourg, 67200, France

  • INCA - Hospital do Cancer III

    Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil

  • IPO Porto

    Porto, Porto District, 4200-072, Portugal

  • IRCCS Istituti Fisioterapici Ospitalieri - IFO

    Rome, Lazio, 144, Italy

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale

    Bordeaux, 33000, France

  • Institut Catala D'oncologia - Oncologia

    Barcelona, L Hospitalet de Llobregat, 8907, Spain

  • Institut Jules Bordet/Jules Bordet Instituut

    Brussels, 1070, Belgium

  • Institut de Cancerologie Ouest - Saint-Herblain

    Saint-Herblain, 44800, France

  • Instituto Nacional de Cancerología INC Colombia

    Bogota, Cundinamarca, 111511, Colombia

  • Instituto Nacional do Câncer - INCA - HC II

    Rio de Janeiro, Rio de Janeiro, 20081-250, Brazil

  • Instituto do Cancer do Estado de Sao Paulo

    São Paulo, São Paulo, 01246-000, Brazil

  • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

    Istanbul, 34098, Turkey (Türkiye)

  • Istanbul Universitesi Istanbul Tip Fakultesi

    Istanbul, 34093, Turkey (Türkiye)

  • Istituto Europeo di Oncologia s.r.l

    Milan, Lombardy, 20141, Italy

  • Istituto Oncologico Veneto

    Padova, Veneto, 35128, Italy

  • Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma

    Izmir, 35360, Turkey (Türkiye)

  • Jawaharlal Institute Of Postgraduate Medical Education and R

    Gorimedu, Puducherry, 605006, India

  • Karolinska Universitetssjukhuset Solna - Tema Cancer

    Stockholm, 171 76, Sweden

  • Macquarie University Hospital

    Sydney, New South Wales, 2109, Australia

  • Mass General Cancer Center

    Boston, Massachusetts, 02114-2696, United States

  • Memorial Cancer Institute at West

    Pembroke Pines, Florida, 33026, United States

  • Memorial Sloan Kettering Cancer Center New York - Main Campus

    New York, New York, 10065, United States

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560, Japan

  • Narodny onkologicky ustav

    Bratislava, 833 10, Slovakia

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • National Cancer Center Singapore - Oncology Department

    Singapore, 168583, Singapore

  • Oncoclínicas Rio de Janeiro S.A

    Rio de Janeiro, Rio de Janeiro, 22250-905, Brazil

  • Oncomédica S.A.

    Montería, Departamento de Córdoba, 230002, Colombia

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

    Bratislava, 812 50, Slovakia

  • Real e Benemérita Associação Portuguesa de Beneficência

    São Paulo, São Paulo, 01323-001, Brazil

  • Republican Clinical Oncology Dispensary Kazan

    Kazan', 420029, Russia

  • Rigshospitalet - Kræftbehandling

    Copenhagen OE, 2100, Denmark

  • Royal Darwin Hospital

    Tiwi, Northern Territory, 810, Australia

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

    Moscow, 115478, Russia

  • Samsung Medical Center - Oncology Department

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 3080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

  • Sichuan University West China Hospital

    Chengdu, Sichuan, MISSING, China

  • Sidney Kimmel Cancer Center - Jefferson Health

    Philadelphia, Pennsylvania, 19107, United States

  • St John of God Healthcare

    Subiaco, Western Australia, 6008, Australia

  • St Vincents University Hospital

    Dublin, TBC, Ireland

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

    Saint Petersburg, 197758, Russia

  • Stanford Cancer Center Palo Alto

    Palo Alto, California, 94304, United States

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000, China

  • TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has

    Istanbul, 34722, Turkey (Türkiye)

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, 135-8550, Japan

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

    Chicago, Illinois, 60637, United States

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

    Houston, Texas, 77030, United States

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2, Canada

  • Trakya Univ. Tip Fak.

    Edirne, 22030, Turkey (Türkiye)

  • Tri-Service General Hospital

    Taipei, 114, Taiwan

  • UCLA Health Santa Monica Cancer Care

    Santa Monica, California, 90404, United States

  • UNC Hospitals - UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27514, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157, United States

  • West Virginia University

    Morgantown, West Virginia, 26505, United States

  • Zhongshan Hospital, Fudan University - Oncology Department

    Shanghai, 200032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.