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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)

Primary Purpose

Breast Cancer, Cholangiocarcinoma, Colorectal Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Entrectinib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dignity Health St Joseph's Hospital and Medical Center
  • Mayo Clinic
  • City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics
  • Scripps Clinic
  • University of California San Diego Moores Cancer Center; Dept of Lung Cancer
  • University of Southern California Medical Center
  • Univ Of California Irvine College Of Medicine; 300194620
  • Southern California Kaiser Permanente
  • UCSF Mount Zion Medical Ctr
  • Sarcoma Oncology Center
  • University of Colorado Cancer Center
  • Yale University
  • Georgetown University Medical Center Lombardi Cancer Center
  • Florida Cancer Specialists - Sarasota
  • H. Lee Moffitt Cancer Center and Research Inst.
  • University Cancer & Blood Center, LLC; Research
  • Winship Cancer Institute
  • Southeastern Regional Medical Center, Inc.
  • Northwestern University
  • Advocate Medical Group - Park Ridge, Luther Lane - Oncology
  • Midwestern Regional Medical Center
  • Weinberg Cancer Institution at Franklin Square
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Dana Farber Cancer Institute
  • University of Michigan Comprehensive Cancer Center; Clinical Trials Office
  • Karmanos Cancer Center
  • Henry Ford Hospital
  • Regents of the University of Minnesota
  • Washington University
  • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
  • North Shore Hem Onc Associates
  • Memorial Sloan Kettering Cancer Center
  • Levine Cancer Institute
  • Duke Cancer Institute
  • OSU, James Cancer Hospital
  • Cancer Treatment Centers of America; Tulsa
  • Oregon Health & Science Univ
  • Cancer Treatment Centers of America - Eastern Regional Medical Center
  • Mary Crowley Medical Research Center
  • University of Texas MD Anderson Cancer Center
  • Baylor Scott & White Health
  • University of Utah Hospitals & Clinics
  • Virginia Cancer Specialists, PC
  • Virginia Oncology Associates - Hampton
  • University of Washington Seattle Cancer Care Alliance
  • Liverpool Hospital
  • Newcastle Private Hospital
  • Flinders Medical Centre
  • Austin Health
  • Antwerp University Hospital
  • Beijing Cancer Hospital
  • Sichuan Provincial Cancer Hospital
  • Cancer Center of Guangzhou Medical University
  • Harbin Medical University Cancer Hospital
  • Fudan University Shanghai Cancer Center
  • Shanghai chest hospital
  • Shenzhen People's Hospital
  • Tianjin Cancer Hospital
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Zhejiang Cancer Hospital
  • Institut de Cancerologie de l Ouest
  • Institut Bergonie; Oncologie
  • Centre Leon Berard; Departement Oncologie Medicale
  • Hôpital de la Timone; Oncologie Médicale Hématologie & Soins Palliatifs
  • Hôpital Nord - AP-HM Marseille#; Service d'Oncologie Multidisciplinaire
  • Institut de Recherche en Cancérologie de Montpellier
  • Institut Curie; Oncologie Medicale
  • Institut De Cancerologie De L'ouest - Rene Gauducheau - Biology
  • Institut Claudius Regaud; Departement Oncologie Medicale
  • Institut Gustave Roussy; Pathologie Thoracique
  • Evang. Lungenklinik Berlin Klinik für Pneumologie
  • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie
  • NCT Uniklinikum Heidelberg; Medizinische Onkologie
  • Universitaetsklinikum Koeln; Innere Medizin I, Haematologie
  • Princess Margaret Hospital
  • The University of Hong Kong
  • Queen Elizabeth Hospital
  • The Chinese University of Hong Kong
  • Seconda Università degli Studi di Napoli; Servizio Epato-Gastroenterologia
  • Università Campus Bio-Medico di Roma; Oncologia Medica
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck
  • Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica
  • Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia ; S.C. Oncologia Medica
  • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
  • Aichi Cancer Center Hospital; Respiratory Medicine
  • NHO Shikoku Cancer Center; Dept of Respiratory Medicine
  • NHO Kyushu Cancer Center
  • Hyogo Cancer Center, Dept of Respiratory Medicine
  • National Cancer Center Hospital; Dept of Respiratory Medicine
  • Miyagi Cancer Center; Respiratory Medicine
  • Niigata Cancer Center Hospital; Internal Medicine
  • OSAKA CITY GENERAL HOSPITAL;Medical Oncology
  • Kindai University Hospital; Medical Oncology
  • Shizuoka Cancer Center; Respiratory Internal Medicine
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • Asan Medical Center.
  • NKI The Netherlands Cancer Institute
  • Leids Universitair Medisch Centrum
  • Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
  • Centrum Onkologii-Instytut im.M.Sklodowskiej Curie; Dept of Nuclear Med. and Endocrine Oncology
  • Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy
  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
  • National University Hospital; Haematology/Oncology
  • National Cancer Centre
  • Centro Nacional de Investigaciones Oncológicas(CNIO); Gastrointestinal Cancer Clinical Research Unit
  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
  • Hospital Universitario Ramon y Cajal; Servicio de Farmacia
  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Hospital Universitario La Paz; Servicio de Oncologia
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • National Cheng Kung University Hospital
  • Taipei Veterans General Hospital
  • National Taiwan University Hospital
  • Addenbrookes Hospital
  • Sarah Cannon Research Institute
  • Christie Hospital Nhs Trust; Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

NTRK1/2/3-rearranged NSCLC

ROS1-rearranged NSCLC

ALK- or ROS1-rearranged NSCLC

NTRK/1/2/3-rearranged mCRC

ROS1-rearranged mCRC

ALK-rearranged mCRC

NTRK1/2/3-rearranged other solid tumor

ROS1-rearranged other solid tumor

ALK-rearranged other solid tumor

Arm Description

Oral entrectinib (RXDX-101)

Oral entrectinib (RXDX-101)

with CNS-only progression previously treated with crizotinib (NOTE: The ALK-rearranged portion of this arm is now closed to enrollment.) Oral entrectinib (RXDX-101)

Oral entrectinib (RXDX-101)

Oral entrectinib (RXDX-101)

Oral entrectinib (RXDX-101)

Oral entrectinib (RXDX-101)

Oral entrectinib (RXDX-101)

Oral entrectinib (RXDX-101)

Outcomes

Primary Outcome Measures

Objective Response Rate
Assessed by blinded independent central review (BICR) using RECIST v1.1

Secondary Outcome Measures

Duration of Response
Assessed by blinded independent central review (BICR) using RECIST v1.1
Time to Response
Assessed by blinded independent central review (BICR) using RECIST v1.1
Clinical Benefit Rate
Assessed by blinded independent central review (BICR) using RECIST v1.1
Intracranial Tumor Response
Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable
CNS Progression-free Survival
Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable
Progression-free Survival
Assessed by Kaplan-Meier method
Overall Survival
Assessed by Kaplan-Meier method
Population PK
Assessed by Kaplan-Meier method
Adverse Events
Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, graded by the NCI CTCAE
Quality of Life
Assessed with the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and the Euro-QoL Group EQ-5D. NSCLC and mCRC patients will complete the lung cancer and colorectal cancer specific modules, QLQ-LC13 and QLQ-CR29, respectively
Bone Growth and Bone Mineral Density
Assessed with DHA scans
Bone Biomarkers
Measured by blood

Full Information

First Posted
October 2, 2015
Last Updated
October 5, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02568267
Brief 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)
Acronym
STARTRK-2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 19, 2015 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
534 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NTRK1/2/3-rearranged NSCLC
Arm Type
Experimental
Arm Description
Oral entrectinib (RXDX-101)
Arm Title
ROS1-rearranged NSCLC
Arm Type
Experimental
Arm Description
Oral entrectinib (RXDX-101)
Arm Title
ALK- or ROS1-rearranged NSCLC
Arm Type
Experimental
Arm Description
with CNS-only progression previously treated with crizotinib (NOTE: The ALK-rearranged portion of this arm is now closed to enrollment.) Oral entrectinib (RXDX-101)
Arm Title
NTRK/1/2/3-rearranged mCRC
Arm Type
Experimental
Arm Description
Oral entrectinib (RXDX-101)
Arm Title
ROS1-rearranged mCRC
Arm Type
Experimental
Arm Description
Oral entrectinib (RXDX-101)
Arm Title
ALK-rearranged mCRC
Arm Type
Experimental
Arm Description
Oral entrectinib (RXDX-101)
Arm Title
NTRK1/2/3-rearranged other solid tumor
Arm Type
Experimental
Arm Description
Oral entrectinib (RXDX-101)
Arm Title
ROS1-rearranged other solid tumor
Arm Type
Experimental
Arm Description
Oral entrectinib (RXDX-101)
Arm Title
ALK-rearranged other solid tumor
Arm Type
Experimental
Arm Description
Oral entrectinib (RXDX-101)
Intervention Type
Drug
Intervention Name(s)
Entrectinib
Other Intervention Name(s)
RXDX-101
Intervention Description
TrkA/B/C, ROS1, and ALK inhibitor
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
Assessed by blinded independent central review (BICR) using RECIST v1.1
Time Frame
Approximately 24 months
Secondary Outcome Measure Information:
Title
Duration of Response
Description
Assessed by blinded independent central review (BICR) using RECIST v1.1
Time Frame
Approximately 24 months
Title
Time to Response
Description
Assessed by blinded independent central review (BICR) using RECIST v1.1
Time Frame
Approximately 24 months
Title
Clinical Benefit Rate
Description
Assessed by blinded independent central review (BICR) using RECIST v1.1
Time Frame
Approximately 24 months
Title
Intracranial Tumor Response
Description
Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable
Time Frame
Approximately 24 months
Title
CNS Progression-free Survival
Description
Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable
Time Frame
Approximately 24 months
Title
Progression-free Survival
Description
Assessed by Kaplan-Meier method
Time Frame
Approximately 30 months
Title
Overall Survival
Description
Assessed by Kaplan-Meier method
Time Frame
Approximately 36 months
Title
Population PK
Description
Assessed by Kaplan-Meier method
Time Frame
Approximately 24 months
Title
Adverse Events
Description
Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, graded by the NCI CTCAE
Time Frame
Approximately 36 months
Title
Quality of Life
Description
Assessed with the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and the Euro-QoL Group EQ-5D. NSCLC and mCRC patients will complete the lung cancer and colorectal cancer specific modules, QLQ-LC13 and QLQ-CR29, respectively
Time Frame
Approximately 24 months
Title
Bone Growth and Bone Mineral Density
Description
Assessed with DHA scans
Time Frame
Approximately 30 months
Title
Bone Biomarkers
Description
Measured by blood
Time Frame
Approximately 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Dignity Health St Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California San Diego Moores Cancer Center; Dept of Lung Cancer
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of Southern California Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Univ Of California Irvine College Of Medicine; 300194620
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Southern California Kaiser Permanente
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
UCSF Mount Zion Medical Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Sarcoma Oncology Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Georgetown University Medical Center Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Florida Cancer Specialists - Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Inst.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University Cancer & Blood Center, LLC; Research
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Southeastern Regional Medical Center, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Advocate Medical Group - Park Ridge, Luther Lane - Oncology
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Midwestern Regional Medical Center
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
Weinberg Cancer Institution at Franklin Square
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center; Clinical Trials Office
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Karmanos Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Regents of the University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
North Shore Hem Onc Associates
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
11101
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
OSU, James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Cancer Treatment Centers of America; Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Oregon Health & Science Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Cancer Treatment Centers of America - Eastern Regional Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Scott & White Health
City
Temple
State/Province
Texas
ZIP/Postal Code
76502
Country
United States
Facility Name
University of Utah Hospitals & Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Oncology Associates - Hampton
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
University of Washington Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Newcastle Private Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Sichuan Provincial Cancer Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Cancer Center of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Facility Name
Shanghai chest hospital
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
ZIP/Postal Code
510852
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430023
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Institut de Cancerologie de l Ouest
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Name
Institut Bergonie; Oncologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Leon Berard; Departement Oncologie Medicale
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hôpital de la Timone; Oncologie Médicale Hématologie & Soins Palliatifs
City
Marseille cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Hôpital Nord - AP-HM Marseille#; Service d'Oncologie Multidisciplinaire
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Institut de Recherche en Cancérologie de Montpellier
City
Montpellier cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
Institut Curie; Oncologie Medicale
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
Institut De Cancerologie De L'ouest - Rene Gauducheau - Biology
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Claudius Regaud; Departement Oncologie Medicale
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Gustave Roussy; Pathologie Thoracique
City
Villejuif cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Evang. Lungenklinik Berlin Klinik für Pneumologie
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
NCT Uniklinikum Heidelberg; Medizinische Onkologie
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitaetsklinikum Koeln; Innere Medizin I, Haematologie
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Princess Margaret Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Elizabeth Hospital
City
Kowloon
Country
Hong Kong
Facility Name
The Chinese University of Hong Kong
City
Shatin
ZIP/Postal Code
123456
Country
Hong Kong
Facility Name
Seconda Università degli Studi di Napoli; Servizio Epato-Gastroenterologia
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Università Campus Bio-Medico di Roma; Oncologia Medica
City
Roma
State/Province
Lazio
ZIP/Postal Code
128
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia ; S.C. Oncologia Medica
City
Perugia
State/Province
Umbria
ZIP/Postal Code
6132
Country
Italy
Facility Name
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Aichi Cancer Center Hospital; Respiratory Medicine
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
NHO Shikoku Cancer Center; Dept of Respiratory Medicine
City
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
NHO Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Hyogo Cancer Center, Dept of Respiratory Medicine
City
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
National Cancer Center Hospital; Dept of Respiratory Medicine
City
Kashiwa-shi
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Miyagi Cancer Center; Respiratory Medicine
City
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
Niigata Cancer Center Hospital; Internal Medicine
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
OSAKA CITY GENERAL HOSPITAL;Medical Oncology
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Kindai University Hospital; Medical Oncology
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Shizuoka Cancer Center; Respiratory Internal Medicine
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Asan Medical Center.
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
NKI The Netherlands Cancer Institute
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
City
Gda?sk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Centrum Onkologii-Instytut im.M.Sklodowskiej Curie; Dept of Nuclear Med. and Endocrine Oncology
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy
City
Pozna?
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
National University Hospital; Haematology/Oncology
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National Cancer Centre
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Centro Nacional de Investigaciones Oncológicas(CNIO); Gastrointestinal Cancer Clinical Research Unit
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal; Servicio de Farmacia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70457
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
Christie Hospital Nhs Trust; Medical Oncology
City
Manchester
ZIP/Postal Code
M2O 4BX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34924145
Citation
Sullivan 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.
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PubMed Identifier
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Citation
Doebele 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. Erratum In: J Comp Eff Res. 2022 May;11(7):545-548.
Results Reference
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PubMed Identifier
33646820
Citation
Dziadziuszko 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.
Results Reference
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PubMed Identifier
31838015
Citation
Drilon 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. Erratum In: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341.
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PubMed Identifier
31838007
Citation
Doebele 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. Erratum In: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341. Lancet Oncol. 2020 Aug;21(8):e372. Lancet Oncol. 2021 Oct;22(10):e428.
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Sigal 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.
Results Reference
derived

Learn more about this trial

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)

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