Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)
STARTRK-2
An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
3 other identifiers
interventional
534
16 countries
130
Brief Summary
This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Nov 2015
Longer than P75 for phase_2 breast-cancer
130 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
First Submitted
Initial submission to the registry
October 2, 2015
CompletedFirst Posted
Study publicly available on registry
October 5, 2015
CompletedStudy Start
First participant enrolled
November 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 14, 2026
March 6, 2026
March 1, 2026
10.5 years
October 2, 2015
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate
Assessed by blinded independent central review (BICR) using RECIST v1.1
Approximately 24 months
Secondary Outcomes (12)
Duration of Response
Approximately 24 months
Time to Response
Approximately 24 months
Clinical Benefit Rate
Approximately 24 months
Intracranial Tumor Response
Approximately 24 months
CNS Progression-free Survival
Approximately 24 months
- +7 more secondary outcomes
Study Arms (9)
NTRK1/2/3-rearranged NSCLC
EXPERIMENTALOral entrectinib (RXDX-101)
ROS1-rearranged NSCLC
EXPERIMENTALOral entrectinib (RXDX-101)
ALK- or ROS1-rearranged NSCLC
EXPERIMENTALwith CNS-only progression previously treated with crizotinib (NOTE: The ALK-rearranged portion of this arm is now closed to enrollment.) Oral entrectinib (RXDX-101)
NTRK/1/2/3-rearranged mCRC
EXPERIMENTALOral entrectinib (RXDX-101)
ROS1-rearranged mCRC
EXPERIMENTALOral entrectinib (RXDX-101)
ALK-rearranged mCRC
EXPERIMENTALOral entrectinib (RXDX-101)
NTRK1/2/3-rearranged other solid tumor
EXPERIMENTALOral entrectinib (RXDX-101)
ROS1-rearranged other solid tumor
EXPERIMENTALOral entrectinib (RXDX-101)
ALK-rearranged other solid tumor
EXPERIMENTALOral entrectinib (RXDX-101)
Interventions
TrkA/B/C, ROS1, and ALK inhibitor
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (130)
Dignity Health St Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Mayo Clinic
Phoenix, Arizona, 85054, United States
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
Scripps Clinic
La Jolla, California, 92037, United States
University of California San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Southern California Kaiser Permanente
Los Angeles, California, 90027, United States
University of Southern California Medical Center
Los Angeles, California, 90032, United States
Univ Of California Irvine College Of Medicine
Orange, California, 92868, United States
UCSF Mount Zion Medical Ctr
San Francisco, California, 94115, United States
UCSF Mission Bay
San Francisco, California, 94158, United States
Sarcoma Oncology Center
Santa Monica, California, 90403, United States
Sarcoma Oncology Research Center LLC
Santa Monica, California, 90403, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 6519, United States
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232, United States
H. Lee Moffitt Cancer Center and Research Inst.
Tampa, Florida, 33612-9497, United States
Moffitt Cancer Center
Tampa, Florida, 33612-9497, United States
University Cancer & Blood Center, LLC
Athens, Georgia, 30607, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Southeastern Regional Medical Center, Inc.
Newnan, Georgia, 30265, United States
Northwestern University
Chicago, Illinois, 60611, United States
Advocate Medical Group - Park Ridge, Luther Lane - Oncology
Park Ridge, Illinois, 60068, United States
Midwestern Regional Medical Center
Zion, Illinois, 60099, United States
Weinberg Cancer Institution at Franklin Square
Baltimore, Maryland, 21237, United States
Massachusetts General Hosp CAR
Boston, Massachusetts, 02114, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Center
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Regents of the University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University
St Louis, Missouri, 63128, United States
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, 89169, United States
North Shore Hem Onc Associates
East Setauket, New York, 11733, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10022, United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
Ohio State University
Columbus, Ohio, 43210, United States
OSU, James Cancer Hospital
Columbus, Ohio, 43210, United States
Cancer Treatment Centers of America
Tulsa, Oklahoma, 74133, United States
Oregon Health & Science University
Portland, Oregon, 97239-3098, United States
Oregon Health & Science Univ
Portland, Oregon, 97239, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75230, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Baylor Scott & White Health
Temple, Texas, 76508, United States
University of Utah Hospitals & Clinics
Salt Lake City, Utah, 84112, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates - Hampton
Norfolk, Virginia, 23502, United States
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Newcastle Private Hospital
Newcastle, New South Wales, 2305, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Pharmacy
Edegem, 2650, Belgium
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430023, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041, China
Beijing Cancer Hospital
Beijing, 100142, China
Cancer Center of Guangzhou Medical University
Guangzhou, 528400, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Shanghai chest hospital
Shanghai, 200030, China
Fudan University Shanghai Cancer Center
Shanghai, 200120, China
Shenzhen People's Hospital
Shenzhen, 510852, China
Institut de Cancerologie de l Ouest
Angers, 49055, France
Institut Bergonie
Bordeaux, 33076, France
Centre Leon Berard
Lyon, 69373, France
Hôpital de la Timone
Marseille, 13385, France
Hôpital Nord - AP-HM Marseille#
Marseille, 13915, France
Institut de Recherche en Cancérologie de Montpellier
Montpellier, 34090, France
Institut Curie
Paris, 75005, France
Institut De Cancerologie De L'ouest - Rene Gauducheau - Biology
Saint-Herblain, 44805, France
Institut Claudius Regaud
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
Evang. Lungenklinik Berlin Klinik für Pneumologie
Berlin, 13125, Germany
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Dresden, 01307, Germany
Universitaetsmedizin Goettingen
Göttingen, 37075, Germany
NCT Uniklinikum Heidelberg
Heidelberg, 69120, Germany
Princess Margaret Hospital
Hong Kong, Hong Kong
The University of Hong Kong
Hong Kong, Hong Kong
Queen Elizabeth Hospital
Kowloon, Hong Kong
The Chinese University of Hong Kong
Shatin, 123456, Hong Kong
Seconda Università degli Studi di Napoli
Naples, Campania, 80131, Italy
Università Campus Bio-Medico di Roma
Rome, Lazio, 128, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
Milan, Lombardy, 20162, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126, Italy
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Perugia, Umbria, 6132, Italy
IOV - Istituto Oncologico Veneto - IRCCS
Padua, Veneto, 35128, Italy
Aichi Cancer Center Hospital
Aichi, 464-8681, Japan
National Cancer Center Hospital
Chūō, 104-0045, Japan
NHO Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Hyogo Cancer Center, Dept of Respiratory Medicine
Hyōgo, 673-8558, Japan
National Cancer Center Hospital
Kashiwa-shi, 277-8577, Japan
NHO Shikoku Cancer Center
Matsuyama, 791-0280, Japan
Miyagi Cancer Center
Miyagi, 981-1293, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Osaka City General Hospital
Osaka, 534-0021, Japan
Kindai University Hospital
Osaka, 589-8511, Japan
Shizuoka Cancer Center
Shizuoka, 411-8777, Japan
NKI The Netherlands Cancer Institute
Amsterdam, 1066 CX, Netherlands
Leids Universitair Medisch Centrum
Leiden, 2333 ZA, Netherlands
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214, Poland
Centrum Onkologii-Instytut im.M.Sklodowskiej Curie
Gliwice, 44-101, Poland
Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego
Późna, 60-569, Poland
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
Warsaw, 02-781, Poland
National University Hospital
Singapore, 119228, Singapore
National Cancer Centre Singapore
Singapore, 168583, Singapore
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center.
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
Centro Nacional de Investigaciones Oncológicas(CNIO)
Fuenlabrada, Madrid, 28942, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
National Cheng Kung University Hospital
Tainan, 70457, Taiwan
National Taiwan University Hospital
Taipei, 00100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Sarah Cannon Research Institute
London, W1G 6AD, United Kingdom
The Christie
Manchester, M20 4BX, United Kingdom
Related Publications (9)
Desai AV, Bagchi A, Armstrong AE, van Tilburg CM, Basu EM, Robinson GW, Wang H, Casanova M, Andre N, Campbell-Hewson Q, Wu Y, Cardenas A, Ci B, Ryklansky C, Devlin CE, Meneses-Lorente G, Wulff J, Hutchinson KE, Gajjar A, Fox E. Efficacy and safety of entrectinib in children with extracranial solid or central nervous system (CNS) tumours harbouring NTRK or ROS1 fusions. Eur J Cancer. 2025 May 2;220:115308. doi: 10.1016/j.ejca.2025.115308. Epub 2025 Feb 22.
PMID: 40086048DERIVEDChoudhury NJ, Jun Woo H, Chen M, Shah R, Donoghue M, Berger M, Drilon A. Serial Cell-Free DNA Sequencing in ROS1 Fusion-Positive Lung Cancers During Treatment With Entrectinib. JCO Precis Oncol. 2024 Jun;8:e2300721. doi: 10.1200/PO.23.00721.
PMID: 38848521DERIVEDYokota T, Yukino H, Doi M, Ohori H. Real-world experience of tropomyosin receptor kinase inhibition with entrectinib in ETV6-NTRK3 positive metastatic salivary secretory carcinoma: A case series. Head Neck. 2023 May;45(5):E10-E15. doi: 10.1002/hed.27346. Epub 2023 Mar 16.
PMID: 36924196DERIVEDSullivan WG, Hatswell AJ. Letter re: 'Intrapatient comparisons of efficacy in a single-arm trial of entrectinib in tumour-agnostic indications'. ESMO Open. 2021 Dec;6(6):100282. doi: 10.1016/j.esmoop.2021.100282. Epub 2021 Oct 28. No abstract available.
PMID: 34924145DERIVEDDoebele RC, Perez L, Trinh H, Martinec M, Martina R, Riehl T, Krebs MG, Meropol NJ, Wong WB, Crane G. Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in ROS1+ NSCLC. J Comp Eff Res. 2021 Dec;10(17):1271-1282. doi: 10.2217/cer-2021-0131. Epub 2021 Aug 24.
PMID: 34427452DERIVEDDziadziuszko R, Krebs MG, De Braud F, Siena S, Drilon A, Doebele RC, Patel MR, Cho BC, Liu SV, Ahn MJ, Chiu CH, Farago AF, Lin CC, Karapetis CS, Li YC, Day BM, Chen D, Wilson TR, Barlesi F. Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Apr 10;39(11):1253-1263. doi: 10.1200/JCO.20.03025. Epub 2021 Mar 1.
PMID: 33646820DERIVEDDrilon A, Siena S, Dziadziuszko R, Barlesi F, Krebs MG, Shaw AT, de Braud F, Rolfo C, Ahn MJ, Wolf J, Seto T, Cho BC, Patel MR, Chiu CH, John T, Goto K, Karapetis CS, Arkenau HT, Kim SW, Ohe Y, Li YC, Chae YK, Chung CH, Otterson GA, Murakami H, Lin CC, Tan DSW, Prenen H, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Doebele RC; trial investigators. Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):261-270. doi: 10.1016/S1470-2045(19)30690-4. Epub 2019 Dec 11.
PMID: 31838015DERIVEDDoebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, Blakely CM, Seto T, Cho BC, Tosi D, Besse B, Chawla SP, Bazhenova L, Krauss JC, Chae YK, Barve M, Garrido-Laguna I, Liu SV, Conkling P, John T, Fakih M, Sigal D, Loong HH, Buchschacher GL Jr, Garrido P, Nieva J, Steuer C, Overbeck TR, Bowles DW, Fox E, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Demetri GD; trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):271-282. doi: 10.1016/S1470-2045(19)30691-6. Epub 2019 Dec 11.
PMID: 31838007DERIVEDSigal D, Tartar M, Xavier M, Bao F, Foley P, Luo D, Christiansen J, Hornby Z, Maneval EC, Multani P. Activity of Entrectinib in a Patient With the First Reported NTRK Fusion in Neuroendocrine Cancer. J Natl Compr Canc Netw. 2017 Nov;15(11):1317-1322. doi: 10.6004/jnccn.2017.7029.
PMID: 29118225DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
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 2, 2015
First Posted
October 5, 2015
Study Start
November 19, 2015
Primary Completion (Estimated)
May 14, 2026
Study Completion (Estimated)
May 14, 2026
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing