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)

Trial Title: 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)

NCT ID: NCT02568267

Condition: 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
Sarcomas
Salivary Gland Cancers
Adult Solid Tumor

Conditions: Official terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Melanoma
Pancreatic Neoplasms
Ovarian Neoplasms
Sarcoma
Brain Neoplasms
Thyroid Neoplasms
Cholangiocarcinoma
Neuroendocrine Tumors
Salivary Gland Neoplasms
Head and Neck Neoplasms
Thyroid Cancer, Papillary
Lymphoma, Large-Cell, Anaplastic
Entrectinib

Conditions: Keywords:
Entrectinib
RXDX-101
TrkA
TrkB
TrkC
NTRK1
NTRK2
NTRK3
ROS1
ALK
Trk Fusions
NTRK Gene Rearrangements
ROS1 Fusions
ROS1 Gene Rearrangements
ALK Fusions
ALK Gene Rearrangements
Basket study
Non-small cell lung cancer
Colorectal cancer
Salivary gland cancers
Primary brain tumors
Melanoma
Sarcomas
Papillary thyroid cancer
Renal cell cancer
Pancreatic cancer
Breast cancer
Cholangiocarcinoma
Head & Neck cancers
Ovarian cancer
Neuroendocrine tumors

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Entrectinib
Description: TrkA/B/C, ROS1, and ALK inhibitor
Arm group label: ALK- or ROS1-rearranged NSCLC
Arm group label: ALK-rearranged mCRC
Arm group label: ALK-rearranged other solid tumor
Arm group label: NTRK/1/2/3-rearranged mCRC
Arm group label: NTRK1/2/3-rearranged NSCLC
Arm group label: NTRK1/2/3-rearranged other solid tumor
Arm group label: ROS1-rearranged NSCLC
Arm group label: ROS1-rearranged mCRC
Arm group label: ROS1-rearranged other solid tumor

Other name: RXDX-101

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Dignity Health St Joseph's Hospital and Medical Center

Address:
City: Phoenix
Zip: 85013
Country: United States

Facility:
Name: Mayo Clinic

Address:
City: Scottsdale
Zip: 85259
Country: United States

Facility:
Name: City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics

Address:
City: Duarte
Zip: 91010
Country: United States

Facility:
Name: Scripps Clinic

Address:
City: La Jolla
Zip: 92037
Country: United States

Facility:
Name: University of California San Diego Moores Cancer Center; Dept of Lung Cancer

Address:
City: La Jolla
Zip: 92093
Country: United States

Facility:
Name: University of Southern California Medical Center

Address:
City: Los Angeles
Zip: 90033
Country: United States

Facility:
Name: Univ Of California Irvine College Of Medicine; 300194620

Address:
City: Orange
Zip: 92868
Country: United States

Facility:
Name: Southern California Kaiser Permanente

Address:
City: San Diego
Zip: 92108
Country: United States

Facility:
Name: UCSF Mount Zion Medical Ctr

Address:
City: San Francisco
Zip: 94115
Country: United States

Facility:
Name: Sarcoma Oncology Center

Address:
City: Santa Monica
Zip: 90403
Country: United States

Facility:
Name: University of Colorado Cancer Center

Address:
City: Aurora
Zip: 80045
Country: United States

Facility:
Name: Yale University

Address:
City: New Haven
Zip: 06510
Country: United States

Facility:
Name: Georgetown University Medical Center Lombardi Cancer Center

Address:
City: Washington
Zip: 20007
Country: United States

Facility:
Name: Florida Cancer Specialists - Sarasota

Address:
City: Sarasota
Zip: 34232
Country: United States

Facility:
Name: H. Lee Moffitt Cancer Center and Research Inst.

Address:
City: Tampa
Zip: 33612
Country: United States

Facility:
Name: University Cancer & Blood Center, LLC; Research

Address:
City: Athens
Zip: 30607
Country: United States

Facility:
Name: Winship Cancer Institute

Address:
City: Atlanta
Zip: 30322
Country: United States

Facility:
Name: Southeastern Regional Medical Center, Inc.

Address:
City: Newnan
Zip: 30265
Country: United States

Facility:
Name: Northwestern University

Address:
City: Chicago
Zip: 60611
Country: United States

Facility:
Name: Advocate Medical Group - Park Ridge, Luther Lane - Oncology

Address:
City: Park Ridge
Zip: 60068
Country: United States

Facility:
Name: Midwestern Regional Medical Center

Address:
City: Zion
Zip: 60099
Country: United States

Facility:
Name: Weinberg Cancer Institution at Franklin Square

Address:
City: Baltimore
Zip: 21237
Country: United States

Facility:
Name: Massachusetts General Hospital

Address:
City: Boston
Zip: 02114
Country: United States

Facility:
Name: Beth Israel Deaconess Medical Center

Address:
City: Boston
Zip: 02215
Country: United States

Facility:
Name: Dana Farber Cancer Institute

Address:
City: Boston
Zip: 02215
Country: United States

Facility:
Name: University of Michigan Comprehensive Cancer Center; Clinical Trials Office

Address:
City: Ann Arbor
Zip: 48109
Country: United States

Facility:
Name: Karmanos Cancer Center

Address:
City: Detroit
Zip: 48201
Country: United States

Facility:
Name: Henry Ford Hospital

Address:
City: Detroit
Zip: 48202
Country: United States

Facility:
Name: Regents of the University of Minnesota

Address:
City: Minneapolis
Zip: 55455
Country: United States

Facility:
Name: Washington University

Address:
City: Saint Louis
Zip: 63128
Country: United States

Facility:
Name: Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

Address:
City: Las Vegas
Zip: 89169
Country: United States

Facility:
Name: North Shore Hem Onc Associates

Address:
City: East Setauket
Zip: 11733
Country: United States

Facility:
Name: Memorial Sloan Kettering Cancer Center

Address:
City: New York
Zip: 11101
Country: United States

Facility:
Name: Levine Cancer Institute

Address:
City: Charlotte
Zip: 28204
Country: United States

Facility:
Name: Duke Cancer Institute

Address:
City: Durham
Zip: 27710
Country: United States

Facility:
Name: OSU, James Cancer Hospital

Address:
City: Columbus
Zip: 43210
Country: United States

Facility:
Name: Cancer Treatment Centers of America; Tulsa

Address:
City: Tulsa
Zip: 74133
Country: United States

Facility:
Name: Oregon Health & Science Univ

Address:
City: Portland
Zip: 97239
Country: United States

Facility:
Name: Cancer Treatment Centers of America - Eastern Regional Medical Center

Address:
City: Philadelphia
Zip: 19124
Country: United States

Facility:
Name: Mary Crowley Medical Research Center

Address:
City: Dallas
Zip: 75230
Country: United States

Facility:
Name: University of Texas MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: Baylor Scott & White Health

Address:
City: Temple
Zip: 76502
Country: United States

Facility:
Name: University of Utah Hospitals & Clinics

Address:
City: Salt Lake City
Zip: 84132
Country: United States

Facility:
Name: Virginia Cancer Specialists, PC

Address:
City: Fairfax
Zip: 22031
Country: United States

Facility:
Name: Virginia Oncology Associates - Hampton

Address:
City: Hampton
Zip: 23666
Country: United States

Facility:
Name: University of Washington Seattle Cancer Care Alliance

Address:
City: Seattle
Zip: 98195
Country: United States

Facility:
Name: Liverpool Hospital

Address:
City: Liverpool
Zip: 2170
Country: Australia

Facility:
Name: Newcastle Private Hospital

Address:
City: New Lambton Heights
Zip: 2305
Country: Australia

Facility:
Name: Flinders Medical Centre

Address:
City: Bedford Park
Zip: 5042
Country: Australia

Facility:
Name: Austin Health

Address:
City: Heidelberg
Zip: 3084
Country: Australia

Facility:
Name: Antwerp University Hospital

Address:
City: Edegem
Zip: 2650
Country: Belgium

Facility:
Name: Beijing Cancer Hospital

Address:
City: Beijing
Zip: 100142
Country: China

Facility:
Name: Sichuan Provincial Cancer Hospital

Address:
City: Chengdu
Zip: 610041
Country: China

Facility:
Name: Cancer Center of Guangzhou Medical University

Address:
City: Guangzhou
Zip: 510000
Country: China

Facility:
Name: Harbin Medical University Cancer Hospital

Address:
City: Harbin
Zip: 150081
Country: China

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai City
Zip: 200120
Country: China

Facility:
Name: Shanghai chest hospital

Address:
City: Shanghai
Zip: 200030
Country: China

Facility:
Name: Shenzhen People's Hospital

Address:
City: Shenzhen
Zip: 510852
Country: China

Facility:
Name: Tianjin Cancer Hospital

Address:
City: Tianjin
Zip: 300060
Country: China

Facility:
Name: Union Hospital Tongji Medical College Huazhong University of Science and Technology

Address:
City: Wuhan City
Zip: 430023
Country: China

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Zhejiang
Zip: 310022
Country: China

Facility:
Name: Institut de Cancerologie de l Ouest

Address:
City: Angers
Zip: 49055
Country: France

Facility:
Name: Institut Bergonie; Oncologie

Address:
City: Bordeaux
Zip: 33076
Country: France

Facility:
Name: Centre Leon Berard; Departement Oncologie Medicale

Address:
City: Lyon
Zip: 69373
Country: France

Facility:
Name: Hôpital de la Timone; Oncologie Médicale Hématologie & Soins Palliatifs

Address:
City: Marseille cedex 5
Zip: 13385
Country: France

Facility:
Name: Hôpital Nord - AP-HM Marseille#; Service d'Oncologie Multidisciplinaire

Address:
City: Marseille
Zip: 13015
Country: France

Facility:
Name: Institut de Recherche en Cancérologie de Montpellier

Address:
City: Montpellier cedex 5
Zip: 34298
Country: France

Facility:
Name: Institut Curie; Oncologie Medicale

Address:
City: Paris
Zip: 75231
Country: France

Facility:
Name: Institut De Cancerologie De L'ouest - Rene Gauducheau - Biology

Address:
City: Saint Herblain
Zip: 44805
Country: France

Facility:
Name: Institut Claudius Regaud; Departement Oncologie Medicale

Address:
City: Toulouse
Zip: 31059
Country: France

Facility:
Name: Institut Gustave Roussy; Pathologie Thoracique

Address:
City: Villejuif cedex
Zip: 94805
Country: France

Facility:
Name: Evang. Lungenklinik Berlin Klinik für Pneumologie

Address:
City: Berlin
Zip: 13125
Country: Germany

Facility:
Name: Universitaetsklinikum Carl Gustav Carus TU Dresden

Address:
City: Dresden
Zip: 01307
Country: Germany

Facility:
Name: Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie

Address:
City: Göttingen
Zip: 37075
Country: Germany

Facility:
Name: NCT Uniklinikum Heidelberg; Medizinische Onkologie

Address:
City: Heidelberg
Zip: 69120
Country: Germany

Facility:
Name: Universitaetsklinikum Koeln; Innere Medizin I, Haematologie

Address:
City: Köln
Zip: 50937
Country: Germany

Facility:
Name: Princess Margaret Hospital

Address:
City: Hong Kong
Country: Hong Kong

Facility:
Name: The University of Hong Kong

Address:
City: Hong Kong
Country: Hong Kong

Facility:
Name: Queen Elizabeth Hospital

Address:
City: Kowloon
Country: Hong Kong

Facility:
Name: The Chinese University of Hong Kong

Address:
City: Shatin
Zip: 123456
Country: Hong Kong

Facility:
Name: Seconda Università degli Studi di Napoli; Servizio Epato-Gastroenterologia

Address:
City: Napoli
Zip: 80131
Country: Italy

Facility:
Name: Università Campus Bio-Medico di Roma; Oncologia Medica

Address:
City: Roma
Zip: 128
Country: Italy

Facility:
Name: Fondazione IRCCS Istituto Nazionale dei Tumori

Address:
City: Milano
Zip: 20133
Country: Italy

Facility:
Name: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck

Address:
City: Milano
Zip: 20162
Country: Italy

Facility:
Name: Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica

Address:
City: Pisa
Zip: 56126
Country: Italy

Facility:
Name: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia ; S.C. Oncologia Medica

Address:
City: Perugia
Zip: 6132
Country: Italy

Facility:
Name: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

Address:
City: Padova
Zip: 35128
Country: Italy

Facility:
Name: Aichi Cancer Center Hospital; Respiratory Medicine

Address:
City: Aichi
Zip: 464-8681
Country: Japan

Facility:
Name: NHO Shikoku Cancer Center; Dept of Respiratory Medicine

Address:
City: Ehime
Zip: 791-0280
Country: Japan

Facility:
Name: NHO Kyushu Cancer Center

Address:
City: Fukuoka
Zip: 811-1395
Country: Japan

Facility:
Name: Hyogo Cancer Center, Dept of Respiratory Medicine

Address:
City: Hyogo
Zip: 673-8558
Country: Japan

Facility:
Name: National Cancer Center Hospital; Dept of Respiratory Medicine

Address:
City: Kashiwa-shi
Zip: 277-8577
Country: Japan

Facility:
Name: Miyagi Cancer Center; Respiratory Medicine

Address:
City: Miyagi
Zip: 981-1293
Country: Japan

Facility:
Name: Niigata Cancer Center Hospital; Internal Medicine

Address:
City: Niigata
Zip: 951-8566
Country: Japan

Facility:
Name: OSAKA CITY GENERAL HOSPITAL;Medical Oncology

Address:
City: Osaka
Zip: 534-0021
Country: Japan

Facility:
Name: Kindai University Hospital; Medical Oncology

Address:
City: Osaka
Zip: 589-8511
Country: Japan

Facility:
Name: Shizuoka Cancer Center; Respiratory Internal Medicine

Address:
City: Shizuoka
Zip: 411-8777
Country: Japan

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

Facility:
Name: Severance Hospital, Yonsei University Health System

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: Asan Medical Center.

Address:
City: Seoul
Zip: 5505
Country: Korea, Republic of

Facility:
Name: NKI The Netherlands Cancer Institute

Address:
City: Amsterdam
Zip: 1066 CX
Country: Netherlands

Facility:
Name: Leids Universitair Medisch Centrum

Address:
City: Leiden
Zip: 2333 ZA
Country: Netherlands

Facility:
Name: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

Address:
City: Gdansk
Zip: 80-214
Country: Poland

Facility:
Name: Centrum Onkologii-Instytut im.M.Sklodowskiej Curie; Dept of Nuclear Med. and Endocrine Oncology

Address:
City: Gliwice
Zip: 44-101
Country: Poland

Facility:
Name: Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy

Address:
City: Pozna?
Zip: 60-569
Country: Poland

Facility:
Name: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Facility:
Name: National University Hospital; Haematology/Oncology

Address:
City: Singapore
Zip: 119074
Country: Singapore

Facility:
Name: National Cancer Centre

Address:
City: Singapore
Zip: 169610
Country: Singapore

Facility:
Name: Centro Nacional de Investigaciones Oncológicas(CNIO); Gastrointestinal Cancer Clinical Research Unit

Address:
City: Fuenlabrada
Zip: 28942
Country: Spain

Facility:
Name: Vall d?Hebron Institute of Oncology (VHIO), Barcelona

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hospital Universitario Ramon y Cajal; Servicio de Farmacia

Address:
City: Madrid
Zip: 28034
Country: Spain

Facility:
Name: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

Address:
City: Madrid
Zip: 28040
Country: Spain

Facility:
Name: Hospital Universitario 12 de Octubre; Servicio de Oncologia

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: Hospital Universitario La Paz; Servicio de Oncologia

Address:
City: Madrid
Zip: 28046
Country: Spain

Facility:
Name: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

Address:
City: Malaga
Zip: 29010
Country: Spain

Facility:
Name: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Address:
City: Sevilla
Zip: 41013
Country: Spain

Facility:
Name: National Cheng Kung University Hospital

Address:
City: Tainan
Zip: 70457
Country: Taiwan

Facility:
Name: Taipei Veterans General Hospital

Address:
City: Taipei City
Zip: 11217
Country: Taiwan

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei
Zip: 10002
Country: Taiwan

Facility:
Name: Addenbrookes Hospital

Address:
City: Cambridge
Zip: CB2 0QQ
Country: United Kingdom

Facility:
Name: Sarah Cannon Research Institute

Address:
City: London
Zip: W1G 6AD
Country: United Kingdom

Facility:
Name: Christie Hospital Nhs Trust; Medical Oncology

Address:
City: Manchester
Zip: M2O 4BX
Country: United Kingdom

Start date: November 19, 2015

Completion date: April 1, 2025

Lead sponsor:
Agency: Hoffmann-La Roche
Agency class: Industry

Source: Hoffmann-La Roche

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02568267