Clinical trial NCT03093116: A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
Official title: A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Locally Advanced Solid Tumors
Metastatic Solid Tumors
Keywords: ALK
ROS1
NTRK
Sarcoma
Lung Neoplasms
Carcinoma, NSCL
NSCLC
Non Small Cell Lung
Thyroid Disease
Colonic Neoplasms
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Disease
Respiratory Tract Disease
Carcinoma, Bronchogenic
Bronchial Neoplasms
Endocrine System Disease
Colorectol Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Disease
Colonic Disease
Intestinal Disease
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Non Small Cell Lung Cancer
Solid Tumors
Rearrangements
TRIDENT-1
TKI
TKI naive
TKI pretreated
Anti-tumor activity
Repotrectinib
Advanced Solid Malignancies
Lead sponsor: Turning Point Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Zai Lab (Shanghai) Co., Ltd.
First posted: 2017-03-28
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction.

Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Detailed description: In Phase 2, study subjects will be enrolled into 6 distinct expansion (EXP) cohorts:

* EXP-1: ROS1 TKI-naïve ROS1+ NSCLC. Up to one prior line of chemotherapy OR immunotherapy is allowed
* EXP-2: 1 Prior ROS1 TKI AND 1 Platinum-based Chemotherapy ROS1+ NSCLC. Disease progression, or intolerant to one prior line of a ROS1 TKI. Must have received one prior line of platinum based chemotherapy OR one prior line of platinum based chemotherapy in combination with immunotherapy before or after a ROS1 TKI
* EXP-3: 2 Prior ROS1 TKIs AND NO Chemotherapy ROS1+ NSCLC. Disease progression, or intolerant to 2 prior lines of a ROS1 TKI treatment. No prior lines of chemotherapy or immunotherapy are allowed.
* EXP-4: 1 Prior ROS1 TKI and NO Chemotherapy or Immunotherapy. Disease progression or intolerant to one prior line of a ROS1 TKI. No prior lines of chemotherapy or immunotherapy are allowed.
* EXP-5: TRK TKI-naïve NTRK+ solid tumors. Any number of prior lines of chemo or immunotherapy is allowed.
* EXP-6: TRK TKI-pretreated NTRK+ solid tumors. Disease progression, or intolerant to 1 or 2 prior TRK TKIs. Any number of prior lines of chemo- or immunotherapy are allowed.

Eligibility criteria: PHASE 1

Key Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) (Stage IV, American Joint Committee on Cancer v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests.
2. ECOG PS 0-1.
3. Age ≥18 (or age ≥ 20 of age as required by local regulation).
4. Capability to swallow capsules intact (without chewing, crushing, or opening).
5. At least 1 measurable target lesion according to RECIST version 1.1. CNS-only measurable disease as defined by RECIST version 1.1 is allowed.
6. Prior cytotoxic chemotherapy is allowed.
7. Prior immunotherapy is allowed.
8. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
9. Patients with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria.
10. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or creatinine clearance Within normal limits or \> 40 mL/min; Total serum bilirubin \< 1.5 × ULN; Liver transaminases (ASTs/ALTs) \< 2.5 × ULN; \< 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); \< 2.5 × ULN; \< 5 × ULN if liver and/or bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation
11. Life expectancy ≥ 3 months.

PHASE 2 Key Inclusion Criteria

1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) that harbors a ROS1, or NTRK1-3 gene fusion.
2. Subject must have a documented ROS1 or NTRK1-3 gene fusion determined by tissue-based local testing using either:

   1. a next-generation sequencing (NGS) or quantitative polymerase chain reaction (qPCR) test will be accepted to determine molecular eligibility.

      • Adequate tumor tissue needs to be sent to the Sponsor designated central diagnostic laboratory for retrospective confirmation by a central diagnostic laboratory test selected by the Sponsor.

      OR
   2. a fluorescence in situ hybridization (FISH) test AND prospective confirmation of fusion status by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment will be accepted to determine molecular eligibility.

      * Adequate tumor tissue must be sent to the Sponsor designated central diagnostic laboratory for prospective confirmation by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
4. Age ≥12 (or age ≥ 20 as required by local regulation).
5. Willing and able to provide written institutional review board (IRB)/institutional ethics committee-approved Informed Consent or an Assent signed by a parent or legal guardian for subjects age 12 to 17.
6. At least 1 measurable target lesion according to RECIST (v1.1) prospectively confirmed by Blinded Independent Central Radiology Review (BICR), selected by Sponsor, PRIOR to enrollment. Subjects with CNS-only measurable disease ≥10 mm as defined by RECIST (v1.1) are eligible.
7. Subjects with advanced solid tumors harboring ROS1, NTRK1, NTRK2, or NTRK3 rearrangement will be assigned into 6 distinct expansion (EXP) cohorts provided all inclusion and exclusion criteria are met.

   i. EXP-1: ROS1 TKI-naïve ROS1+ NSCLC ii. EXP-2: 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC iii. EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO) iv. EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO) v. EXP-5: TRK TKI-naïve NTRK+ solid tumors vi. EXP-6: TRK TKI-pretreated NTRK+ solid tumors
8. Subjects with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria.
9. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or creatinine clearance \> 40 mL/min; Total serum bilirubin \< 1.5 × ULN; Liver transaminases (ASTs/ALTs) \< 2.5 × ULN; \< 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); \< 2.5 × ULN; \< 5 × ULN if liver and/or bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation
10. Life expectancy ≥ 3 months.

Key Exclusion Criteria PHASE 1 and PHASE 2

1. Concurrent participation in another therapeutic clinical trial.
2. Symptomatic brain metastases or leptomeningeal involvement.
3. History of previous cancer, except for squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected, requiring therapy within the previous 2 years.
4. Major surgery within 4 weeks of start of repotrectinib treatment. Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Palliative radiation (≤10 fractions) must have been completed at least 48 hours prior to study entry
5. Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment): myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥ II), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic medication. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2
6. Any of the following cardiac criteria:

   Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTcF) \> 470 msec obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \> 250 msec) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval.
7. Known active infections (bacterial, fungal, viral including HIV positivity).
8. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.
9. Peripheral neuropathy of CTCAE ≥grade 2.
10. History of extensive, disseminated, bilateral, or presence of CTCAE grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis. Subjects with history of prior radiation pneumonitis are not excluded.

Primary outcomes:
measure: Dose limiting toxicities (DLTs) (Phase 1)
timeFrame: Within 28 days of the first repotrectinib dose
measure: Recommended Phase 2 Dose (RP2D) (Phase 1)
timeFrame: Within 28 days of the last patient dosed in escalation
measure: Overall Response Rate (ORR) Phase 2
timeFrame: Two to three years after first dose of repotrectinib dose
Secondary outcomes:
measure: Maximum plasma concentration (CMAX) of repotrectinib (TPX-0005) (Phase 1)
timeFrame: Up to 72 hours post dose
measure: Area under the plasma concentration time curve (AUC) of repotrectinib (TPX-0005) (Phase 1)
timeFrame: Up to 72 hours post dose
measure: Area under the plasma concentration time curve (AUC) of repotrectinib under different food intake conditions(TPX-0005) (Phase 1)
timeFrame: Up to 72 hours post dose
measure: Maximum plasma concentration (CMAX) of repotrectinib under different food intake conditions(TPX-0005) (Phase 1)
timeFrame: Up to 72 hours post dose
measure: Area under the plasma concentration time curve (AUC) of midazolam(TPX-0005) (Phase 1)
timeFrame: Up to 24 hours post dose
measure: Maximum plasma concentration (CMAX) of midazolam(TPX-0005) (Phase 1)
timeFrame: Up to 24 hours post dose
measure: Plasma concentration of repotrectinib following administration at RP2D (Phase 2)
timeFrame: Pre dose and 4 hours post dose
measure: Preliminary objective response rate (ORR) (Phase 1)
timeFrame: Approximately three years
measure: Duration of response (DOR) (Phase 2)
timeFrame: Approximately three years
measure: Clinical benefit rate (CBR) (Phase 2)
timeFrame: Approximately three years
measure: Progression free survival (PFS) (Phase 2)
timeFrame: Approximately three years
measure: Overall survival (OS) (Phase 2)
timeFrame: Approximately three years
measure: Intracranial objective response rate (Phase 2)
timeFrame: Approximately three years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City Of Hope
state: California
city: Glendale
country: United States
facility: Local Institution - 2120
state: California
city: La Jolla
country: United States
facility: Local Institution - 2136
state: California
city: La Jolla
country: United States
facility: UC San Diego Health
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Santa Rosa
country: United States
facility: St Joseph Heritage Healthcare
state: California
city: Aurora
country: United States
facility: Local Institution - 1003
state: Colorado
city: Aurora
country: United States
facility: University Of Colorado Denver
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
state: District of Columbia
city: Washington
country: United States
facility: Local Institution - 2110
state: District of Columbia
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Tampa
country: United States
facility: Local Institution - 2113
state: Florida
city: Athens
country: United States
facility: University Cancer and Blood Center
state: Georgia
city: Columbus
country: United States
facility: Local Institution - 2134
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Peoria
country: United States
facility: Local Institution - 2142
state: Illinois
city: New Orleans
country: United States
facility: Local Institution - 2116
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital,
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 1004
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute.
state: Massachusetts
city: Ann Arbor
country: United States
facility: Local Institution - 2105
state: Michigan
city: Detroit
country: United States
facility: Local Institution - 2111
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Transplant Institute
state: Michigan
city: Saint Paul
country: United States
facility: Local Institution - 2132
state: Minnesota
city: Bolivar
country: United States
facility: Local Institution - 2147
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Infusion Center Pharmacy
state: Missouri
city: New Brunswick
country: United States
facility: Local Institution - 2122
state: New Jersey
city: New York
country: United States
facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Goldsboro
country: United States
facility: Local Institution - 2144
state: North Carolina
city: Canton
country: United States
facility: Local Institution - 2112
state: Ohio
city: Cincinnati
country: United States
facility: Trihealth Cancer Institute
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 2109
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Toledo
country: United States
facility: Local Institution - 2119
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Memorial Hospital Baptist Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Local Institution - 2127
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Kingwood
country: United States
facility: Local Institution - 2146
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Seattle
country: United States
facility: University of Washington-Seattle Cancer Care Alliance
state: Washington
city: Tacoma
country: United States
facility: Local Institution - 2141
state: Washington
city: Appleton
country: United States
facility: ThedaCare
state: Wisconsin
city: Camperdown
country: Australia
facility: Chris O'Brien LifeHouse
state: New South Wales
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre - East Melbourne
city: Antwerp
country: Belgium
facility: Uza (University Hospital Antwerp)
city: Leuven
country: Belgium
facility: UZ Leuven PHARMACY CLINICAL TRIALS
city: Edmonton
country: Canada
facility: Cross Cancer Institute.
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution - 2205
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution - 6503
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Ontario
country: Canada
facility: William Osler Health System
city: Ottawa
country: Canada
facility: The Ottawa Hospital
city: Beijing
country: China
facility: Local Institution - 6702
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital
state: Beijing
city: Daping
country: China
facility: Daping Hospital, the Third Affiliated Hospital of Third Military Medical University /Cancer Center
state: Chongqing
city: Fuzhou
country: China
facility: Local Institution - 6719
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University-oncology
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People'S Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 6733
state: Guangdong
city: Shenzhen
country: China
facility: Local Institution - 6505
state: Guangdong
city: Harbin
country: China
facility: The Affiliated Tumor Hospital of Harbin Medical University
state: Heilongjiang
city: Shatin
country: China
facility: Local Institution - 6504
state: Hong Kong
city: Wuhan
country: China
facility: Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology/Cancer Center Department
state: Hubei
city: Changsha
country: China
facility: Local Institution - 6705
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital-thoracic oncology II
state: Hunan
city: Nanjing
country: China
facility: Local Institution - 6748
state: Jiangsu
city: Xuzhou City
country: China
facility: XuZhou Central Hospital/Oncology Department
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital/Medical Oncology Department
state: Jilin
city: Changchun
country: China
facility: Jilin Cancer Hospital/Medical Oncology Department
state: Jilin
city: Changchun
country: China
facility: The first hospital of Jilin university-Oncology Department
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shan3xi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Chengdu City
country: China
facility: Sichuan Cancer Hospital/Medical Oncology Department
state: Sichuan
city: Chongqing
country: China
facility: The First Hospital Affiliated To AMU - Southwest Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Local Institution - 6725
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital-Oncology
state: Zhejiang
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University/Department of Respiratory and Critical Care Medicine
city: Chengdu
country: China
facility: West China Hospital Sichuan University/Lung cancer center
city: Hangzhou
country: China
facility: The First Affiliated Hospital - Zhejiang University School of Medicine
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Weifang City
country: China
facility: Weifang People's Hospital/Medical Oncology Department
city: Zhengzhou
country: China
facility: Henan Cancer Hospital/The 1st pneumology department
city: Copenhagen
country: Denmark
facility: Local Institution - 4901
city: Marseille
country: France
facility: Hopital De La Timone
state: Bouches-du-Rhône
city: Brest
country: France
facility: Local Institution - 4207
city: Dijon Cedex
country: France
facility: Centre Georges-Francois Leclerc
city: Grenoble Cedex 9
country: France
facility: Centre Hospitalier Universitarie Grenoble Alpes (Chuga)
city: Nice
country: France
facility: Centre Antoine-Lacassagne
city: Poitiers
country: France
facility: Chu Poitiers
city: St Mande
country: France
facility: Local Institution - 4203
city: Villejuif
country: France
facility: Institute Gustave Roussy
city: Berlin
country: Germany
facility: Local Institution - 4704
city: Dresden
country: Germany
facility: University Clinic Carl Gustav Carus
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Koln
country: Germany
facility: Centrum für Integrierte Onkologie - Universitaetsklinikum Koeln
city: Hong Kong
country: Hong Kong
facility: Local Institution - 6502
city: Hong Kong
country: Hong Kong
facility: Local Institution - 6501
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Országos Korányi TBC és Pulmonológiai Intézet
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: MI
city: Milano
country: Italy
facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
city: Palermo
country: Italy
facility: Local Institution - 4307
city: Pordenone
country: Italy
facility: Centro di Riferimento Oncologico
city: Ravenna
country: Italy
facility: Local Institution - 4304
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: IRCCS Istituto Regina Elena Oncologia Medica 2
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria Terni
city: Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Yokohama
country: Japan
facility: Kanagawa cancer center
state: Kanagawa
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital
state: Osaka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital.
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer institute
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
city: Hwasun-eup, Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeonnam
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System
state: Seodaemun-gu
city: Seoul
country: Korea, Republic of
facility: Local Institution - 3002
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Local Institution - 3001
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Local Institution - 6307
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Gdańsk
country: Poland
facility: Ośrodek Badań Klinicznych Wczesnych Faz, Uniwersyteckie Centrum Kliniczne
city: Lublin
country: Poland
facility: Local Institution - 4604
city: Poznań
country: Poland
facility: Local Institution - 4605
city: Szczecin
country: Poland
facility: Local Institution - 4603
city: Warszawa
country: Poland
facility: Klinika Nowotworow Pluca i Klatki Piersiowej
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Center Singapore
city: Barcelona
country: Spain
facility: Hospital Universitario Dexeus - Grupo Quironsalud
city: Barcelona
country: Spain
facility: Hospital Unversitario Val D'Hebrón
city: Madrid
country: Spain
facility: Fundacion Md Anderson
city: Madrid
country: Spain
facility: START Madrid-FJD
city: Madrid
country: Spain
facility: Hospital Universitario 12 De Octubre
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro CIOCC
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología (IVO) - Unidad de Investigación Clínica FINCIVO
city: Taiepi
country: Taiwan
facility: Local Institution - 6201
city: Tainan
country: Taiwan
facility: Local Institution - 6203
city: Taipei
country: Taiwan
facility: Local Institution - 6202
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: London
country: United Kingdom
facility: Local Institution - 4402
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute Central Office
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Yun MR, Kim DH, Kim SY, Joo HS, Lee YW, Choi HM, Park CW, Heo SG, Kang HN, Lee SS, Schoenfeld AJ, Drilon A, Kang SG, Shim HS, Hong MH, Cui JJ, Kim HR, Cho BC. Repotrectinib Exhibits Potent Antitumor Activity in Treatment-Naive and Solvent-Front-Mutant ROS1-Rearranged Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Jul 1;26(13):3287-3295. doi: 10.1158/1078-0432.CCR-19-2777. Epub 2020 Apr 8.
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