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New drug targets rare gene fusions in multiple cancers

NCT ID NCT02568267

Disease control Sponsor: Hoffmann-La Roche 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This phase 2 study tests the drug entrectinib in over 500 people with advanced solid tumors that have specific gene changes (NTRK, ROS1, or ALK fusions). The goal is to see if the drug can shrink tumors and control the disease. Participants have various cancer types, including lung, breast, and brain cancers.

What this could mean

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

Active substance
entrectinib (a targeted cancer drug)
What this could lead to
If successful, this could provide a new treatment option for people with certain rare gene changes in their tumors, potentially shrinking or controlling their cancer.
What could go wrong
This is a mid-stage trial, so results are not yet proven. The drug may not work for all tumor types, and side effects are possible. It is not a cure.

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

534 people

The number who actually took part.

Started

Nov 2015

Expected to finish

Jun 2027

An estimate. End dates often move.

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: * Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement * For patients enrolled via local molecular testing, an archival or fresh tumor tissue (unless medically contraindicated) is required to be submitted for independent central molecular testing at Ignyta's CLIA laboratory post-enrollment * Measurable or evaluable disease * Patients with CNS involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously-treated and controlled, are allowed * Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements) \- Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited. * At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy * At least 4 weeks must have elapsed since completion of antibody-directed therapy * Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and minimum life expectancy of 4 weeks * Adequate organ function as defined per protocol * Ability to swallow entrectinib intact * Other protocol specified criteria Exclusion Criteria: * Current participation in another therapeutic clinical trial * Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements \- Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited. * History of other previous cancer that would interfere with the determination of safety or efficacy * Familial or personal history of congenital bone disorders, or bone metabolism alterations * Incomplete recovery from any surgery * History of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction ≤50% observed during screening for the study * History of non-pharmacologically induced prolonged QTc interval * History of additional risk factors for torsades de pointes * Peripheral neuropathy Grade ≥ 2 * Known active infections * Active gastrointestinal disease or other malabsorption syndromes * Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis * Other protocol specified criteria

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Conditions

The condition(s) this trial relates to.

anaplastic large cell lymphoma brain cancer breast cancer breast neoplasm cholangiocarcinoma colorectal cancer colorectal neoplasm head and neck neoplasm Head and Neck Neoplasms malignant pancreatic neoplasm melanoma neoplasm neuroendocrine neoplasm non-small cell lung carcinoma ovarian cancer pancreatic neoplasm primary brain neoplasm renal cell carcinoma salivary gland cancer sarcoma Thyroid Cancer, Papillary thyroid gland papillary carcinoma

As listed by the trial registrant

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

Adult solid tumor Breast cancer Cholangiocarcinoma Colorectal cancer Head and neck neoplasms Lymphoma, large-cell, anaplastic Melanoma Neuroendocrine tumors Non-small cell lung cancer Ovarian cancer Pancreatic cancer Papillary thyroid cancer Primary brain tumors Renal cell carcinoma Salivary gland cancers Sarcomas

Contacts and locations

Locations

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Advocate Medical Group - Park Ridge, Luther Lane - Oncology

    Park Ridge, Illinois, 60068, United States

  • Aichi Cancer Center Hospital

    Aichi, 464-8681, Japan

  • Asan Medical Center.

    Seoul, 05505, South Korea

  • Atrium Health Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

    Perugia, Umbria, 6132, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56126, Italy

  • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

    Milan, Lombardy, 20162, Italy

  • Baylor Scott & White Health

    Temple, Texas, 76508, United States

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Cancer Center of Guangzhou Medical University

    Guangzhou, 528400, China

  • Cancer Treatment Centers of America

    Tulsa, Oklahoma, 74133, United States

  • Centre Leon Berard

    Lyon, 69373, France

  • Centro Nacional de Investigaciones Oncológicas(CNIO)

    Fuenlabrada, Madrid, 28942, Spain

  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

    Warsaw, 02-781, Poland

  • Centrum Onkologii-Instytut im.M.Sklodowskiej Curie

    Gliwice, 44-101, Poland

  • City of Hope Cancer Center

    Duarte, California, 91010, United States

  • City of Hope Duarte - Comprehensive Cancer Center, Investigational Drug Services

    Duarte, California, 91010, United States

  • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

    Las Vegas, Nevada, 89169, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dignity Health St Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013, United States

  • Duke Cancer Institute

    Durham, North Carolina, 27710, United States

  • Evang. Lungenklinik Berlin Klinik für Pneumologie

    Berlin, 13125, Germany

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Florida Cancer Specialists - Sarasota

    Sarasota, Florida, 34232, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133, Italy

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120, China

  • Georgetown University Medical Center Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007, United States

  • H. Lee Moffitt Cancer Center and Research Inst.

    Tampa, Florida, 33612-9497, United States

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hyogo Cancer Center, Dept of Respiratory Medicine

    Hyōgo, 673-8558, Japan

  • Hôpital Nord - AP-HM Marseille#

    Marseille, 13915, France

  • Hôpital de la Timone

    Marseille, 13385, France

  • IOV - Istituto Oncologico Veneto - IRCCS

    Padova, Veneto, 35128, Italy

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Claudius Regaud

    Toulouse, 31059, France

  • Institut Curie

    Paris, 75005, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut de Cancerologie de l Ouest

    Angers, 49055, France

  • Institut de Recherche en Cancérologie de Montpellier

    Montpellier, 34090, France

  • Karmanos Cancer Center

    Detroit, Michigan, 48201, United States

  • Kindai University Hospital

    Osaka, 589-8511, Japan

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA, Netherlands

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75230, United States

  • Massachusetts General Hosp CAR

    Boston, Massachusetts, 02114, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10022, United States

  • Midwestern Regional Medical Center

    Zion, Illinois, 60099, United States

  • Miyagi Cancer Center

    Miyagi, 981-1293, Japan

  • Moffitt Cancer Center

    Tampa, Florida, 33612-9497, United States

  • NCT Uniklinikum Heidelberg

    Heidelberg, 69120, Germany

  • NHO Shikoku Cancer Center

    Matsuyama, 791-0280, Japan

  • National Cancer Center Hospital

    Chūō, 104-0045, Japan

  • National Cancer Centre Singapore

    Singapore, 168583, Singapore

  • National Cheng Kung University Hospital

    Tainan, 70457, Taiwan

  • National Taiwan University Hospital

    Taipei, 00100, Taiwan

  • National University Hospital

    Singapore, 119228, Singapore

  • Newcastle Private Hospital

    Newcastle, New South Wales, 2305, Australia

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • North Shore Hem Onc Associates

    East Setauket, New York, 11733, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • OSU, James Cancer Hospital

    Columbus, Ohio, 43210, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Oregon Health & Science Univ

    Portland, Oregon, 97239, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239-3098, United States

  • Osaka City General Hospital

    Osaka, 534-0021, Japan

  • Pharmacy

    Edegem, 2650, Belgium

  • Princess Margaret Hospital

    Hong Kong, Hong Kong

  • Queen Elizabeth Hospital

    Kowloon, Hong Kong

  • Regents of the University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute

    London, W1G 6AD, United Kingdom

  • Sarcoma Oncology Center

    Santa Monica, California, 90403, United States

  • Sarcoma Oncology Research Center LLC

    Santa Monica, California, 90403, United States

  • Scripps Clinic

    La Jolla, California, 92037, United States

  • Seconda Università degli Studi di Napoli

    Naples, Campania, 80131, Italy

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752, South Korea

  • Shanghai chest hospital

    Shanghai, 200030, China

  • Shenzhen People's Hospital

    Shenzhen, 510852, China

  • Shizuoka Cancer Center

    Shizuoka, 411-8777, Japan

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041, China

  • Southeastern Regional Medical Center, Inc.

    Newnan, Georgia, 30265, United States

  • Southern California Kaiser Permanente

    Los Angeles, California, 90027, United States

  • Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego

    Późna, 60-569, Poland

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The Chinese University of Hong Kong

    Shatin, 123456, Hong Kong

  • The Christie

    Manchester, M20 4BX, United Kingdom

  • The University of Hong Kong

    Hong Kong, Hong Kong

  • UCSF Mission Bay

    San Francisco, California, 94158, United States

  • UCSF Mount Zion Medical Ctr

    San Francisco, California, 94115, United States

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430023, China

  • Univ Of California Irvine College Of Medicine

    Orange, California, 92868, United States

  • Universitaetsklinikum Koeln

    Cologne, 50937, Germany

  • Universitaetsmedizin Goettingen

    Göttingen, 37075, Germany

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607, United States

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045, United States

  • Università Campus Bio-Medico di Roma

    Rome, Lazio, 128, Italy

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214, Poland

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035, Spain

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031, United States

  • Virginia Oncology Associates - Hampton

    Norfolk, Virginia, 23502, United States

  • Washington University

    St Louis, Missouri, 63128, United States

  • Weinberg Cancer Institution at Franklin Square

    Baltimore, Maryland, 21237, United States

  • Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Yale University

    New Haven, Connecticut, 6519, United States

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

More trials for these conditions

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