A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

NCT ID: NCT03093116

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-07

Study Completion Date

2028-02-29

Brief Summary

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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

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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.

Conditions

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Locally Advanced Solid Tumors Metastatic Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Repotrectinib (TPX-0005)

Phase 1

Oral repotrectinib (TPX-0005):

Phase 1a dose escalation, Phase 1b food-effect sub-study, and Phase 1c dose escalation with food, and Midazolam drug-drug interaction sub-study.

Phase 2

Oral repotrectinib (TPX-0005): 6 distinct expansion cohorts

* EXP-1: ROS1 TKI-naïve ROS1+ NSCLC
* EXP-2: 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC
* EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO)
* EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO)
* EXP-5: TRK TKI-naïve NTRK+ solid tumors
* EXP-6: TRK TKI-pretreated NTRK+ solid tumors

Group Type EXPERIMENTAL

Oral repotrectinib (TPX-0005)

Intervention Type DRUG

Oral repotrectinib (TPX-0005) capsules.

Interventions

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Oral repotrectinib (TPX-0005)

Oral repotrectinib (TPX-0005) capsules.

Intervention Type DRUG

Other Intervention Names

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repotrectinib

Eligibility Criteria

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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.


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.

Exclusion Criteria

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.


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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zai Lab (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Turning Point Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 2129

Duarte, California, United States

Site Status COMPLETED

Local Institution - 2120

Glendale, California, United States

Site Status COMPLETED

Local Institution - 2136

La Jolla, California, United States

Site Status WITHDRAWN

Local Institution - 2114

La Jolla, California, United States

Site Status COMPLETED

Local Institution - 2121

Long Beach, California, United States

Site Status COMPLETED

Local Institution - 2101

Orange, California, United States

Site Status COMPLETED

University of California Irvine Medical Center

Orange, California, United States

Site Status RECRUITING

Local Institution - 2126

Santa Rosa, California, United States

Site Status COMPLETED

Local Institution - 1003

Aurora, Colorado, United States

Site Status NOT_YET_RECRUITING

Local Institution - 2103

Aurora, Colorado, United States

Site Status COMPLETED

Local Institution - 2106

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

Site Status COMPLETED

Local Institution - 2110

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

Site Status COMPLETED

Local Institution - 2128

Hollywood, Florida, United States

Site Status COMPLETED

Local Institution - 2113

Tampa, Florida, United States

Site Status COMPLETED

Local Institution - 2139

Athens, Georgia, United States

Site Status COMPLETED

Local Institution - 2134

Columbus, Georgia, United States

Site Status COMPLETED

Local Institution - 2125

Chicago, Illinois, United States

Site Status COMPLETED

Local Institution - 2142

Peoria, Illinois, United States

Site Status COMPLETED

Local Institution - 2116

New Orleans, Louisiana, United States

Site Status NOT_YET_RECRUITING

Local Institution - 2133

Baltimore, Maryland, United States

Site Status COMPLETED

Local Institution - 2104

Boston, Massachusetts, United States

Site Status COMPLETED

Local Institution - 1004

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Local Institution - 2131

Boston, Massachusetts, United States

Site Status COMPLETED

Local Institution - 2105

Ann Arbor, Michigan, United States

Site Status COMPLETED

Local Institution - 2111

Detroit, Michigan, United States

Site Status COMPLETED

Local Institution - 2140

Detroit, Michigan, United States

Site Status COMPLETED

Local Institution - 2132

Saint Paul, Minnesota, United States

Site Status COMPLETED

Local Institution - 2147

Bolivar, Missouri, United States

Site Status COMPLETED

Local Institution - 2115

St Louis, Missouri, United States

Site Status COMPLETED

Local Institution - 2122

New Brunswick, New Jersey, United States

Site Status COMPLETED

Local Institution - 2117

New York, New York, United States

Site Status COMPLETED

Local Institution - 2102

New York, New York, United States

Site Status COMPLETED

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Local Institution - 2144

Goldsboro, North Carolina, United States

Site Status COMPLETED

Local Institution - 2112

Canton, Ohio, United States

Site Status COMPLETED

Local Institution - 2143

Cincinnati, Ohio, United States

Site Status COMPLETED

Local Institution - 2109

Cleveland, Ohio, United States

Site Status COMPLETED

Local Institution - 2123

Columbus, Ohio, United States

Site Status COMPLETED

Local Institution - 2119

Toledo, Ohio, United States

Site Status COMPLETED

Local Institution - 2108

Philadelphia, Pennsylvania, United States

Site Status COMPLETED

Local Institution - 2148

Memphis, Tennessee, United States

Site Status COMPLETED

Local Institution - 2130

Dallas, Texas, United States

Site Status COMPLETED

Local Institution - 2127

Houston, Texas, United States

Site Status COMPLETED

Local Institution - 2138

Houston, Texas, United States

Site Status COMPLETED

Local Institution - 2146

Kingwood, Texas, United States

Site Status COMPLETED

Local Institution - 2137

Fairfax, Virginia, United States

Site Status COMPLETED

Local Institution - 2107

Seattle, Washington, United States

Site Status COMPLETED

Local Institution - 2141

Tacoma, Washington, United States

Site Status WITHDRAWN

Local Institution - 2145

Appleton, Wisconsin, United States

Site Status COMPLETED

Local Institution - 6102

Camperdown, New South Wales, Australia

Site Status COMPLETED

Local Institution - 6103

Adelaide, South Australia, Australia

Site Status COMPLETED

Local Institution - 6101

Melbourne, Victoria, Australia

Site Status COMPLETED

Local Institution - 3301

East Melbourne, , Australia

Site Status COMPLETED

Local Institution - 4802

Antwerp, , Belgium

Site Status COMPLETED

Local Institution - 4801

Leuven, , Belgium

Site Status COMPLETED

Local Institution - 2202

Edmonton, Alberta, Canada

Site Status COMPLETED

Local Institution - 2205

Vancouver, British Columbia, Canada

Site Status WITHDRAWN

Local Institution - 2201

Toronto, Ontario, Canada

Site Status COMPLETED

Local Institution - 6503

Toronto, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Local Institution - 2203

Ontario, , Canada

Site Status COMPLETED

Local Institution - 2204

Ottawa, , Canada

Site Status COMPLETED

Local Institution - 6702

Beijing, Beijing Municipality, China

Site Status COMPLETED

Beijing Cancer hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Daping Hospital, the Third Affiliated Hospital of Third Military Medical University /Cancer Center

Daping, Chongqing Municipality, China

Site Status RECRUITING

Local Institution - 6719

Fuzhou, Fujian, China

Site Status COMPLETED

The First Affiliated hospital of Xiamen University-oncology

Xiamen, Fujian, China

Site Status RECRUITING

Guangdong Provincial People'S Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Local Institution - 6733

Guangzhou, Guangdong, China

Site Status COMPLETED

Local Institution - 6505

Shenzhen, Guangdong, China

Site Status ACTIVE_NOT_RECRUITING

The Affiliated Tumor Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

Local Institution - 6504

Shatin, HONG KONG, China

Site Status ACTIVE_NOT_RECRUITING

Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology/Cancer Center Department

Wuhan, Hubei, China

Site Status RECRUITING

Local Institution - 6705

Changsha, Hunan, China

Site Status COMPLETED

Hunan Cancer Hospital-thoracic oncology II

Changsha, Hunan, China

Site Status RECRUITING

Local Institution - 6748

Nanjing, Jiangsu, China

Site Status COMPLETED

XuZhou Central Hospital/Oncology Department

Xuzhou, Jiangsu, China

Site Status RECRUITING

Jilin Cancer Hospital/Medical Oncology Department

Changchun, Jilin, China

Site Status RECRUITING

Jilin Cancer Hospital/Medical Oncology Department

Changchun, Jilin, China

Site Status RECRUITING

The first hospital of Jilin university-Oncology Department

Changchun, Jilin, China

Site Status RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Site Status RECRUITING

Tangdu Hospital

Xi'an, Shan3xi, China

Site Status RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Site Status RECRUITING

Sichuan Cancer Hospital/Medical Oncology Department

Chengdu, Sichuan, China

Site Status RECRUITING

The First Hospital Affiliated To AMU - Southwest Hospital

Chongqing, Sichuan, China

Site Status RECRUITING

Local Institution - 6725

Hangzhou, Zhejiang, China

Site Status COMPLETED

Zhejiang Cancer Hospital-Oncology

Hangzhou, Zhejiang, China

Site Status RECRUITING

The Third Xiangya Hospital of Central South University/Department of Respiratory and Critical Care Medicine

Changsha, , China

Site Status RECRUITING

West China Hospital Sichuan University/Lung cancer center

Chengdu, , China

Site Status RECRUITING

The First Affiliated Hospital - Zhejiang University School of Medicine

Hangzhou, , China

Site Status RECRUITING

Anhui Provincial Hospital

Hefei, , China

Site Status RECRUITING

Shanghai Chest Hospital

Shanghai, , China

Site Status RECRUITING

Shanghai Chest Hospital

Shanghai, , China

Site Status RECRUITING

Weifang People's Hospital/Medical Oncology Department

Weifang, , China

Site Status RECRUITING

Henan Cancer Hospital/The 1st pneumology department

Zhengzhou, , China

Site Status RECRUITING

Local Institution - 4901

Copenhagen, , Denmark

Site Status COMPLETED

Local Institution - 4201

Marseille, Bouches-du-Rhône, France

Site Status COMPLETED

Local Institution - 4207

Brest, , France

Site Status COMPLETED

Local Institution - 4204

Dijon, , France

Site Status COMPLETED

Local Institution - 4206

Grenoble, , France

Site Status COMPLETED

Centre Antoine-Lacassagne

Nice, , France

Site Status RECRUITING

Chu Poitiers

Poitiers, , France

Site Status RECRUITING

Local Institution - 4203

Saint-Mandé, , France

Site Status COMPLETED

Institute Gustave Roussy

Villejuif, , France

Site Status RECRUITING

Local Institution - 4704

Berlin, , Germany

Site Status COMPLETED

Local Institution - 4701

Cologne, , Germany

Site Status COMPLETED

Local Institution - 4703

Dresden, , Germany

Site Status COMPLETED

Local Institution - 4702

Heidelberg, , Germany

Site Status COMPLETED

Local Institution - 6502

Hong Kong, , Hong Kong

Site Status ACTIVE_NOT_RECRUITING

Local Institution - 6501

Hong Kong, , Hong Kong

Site Status ACTIVE_NOT_RECRUITING

Local Institution - 5101

Budapest, , Hungary

Site Status COMPLETED

Local Institution - 5103

Budapest, , Hungary

Site Status COMPLETED

Local Institution - 4301

Milan, MI, Italy

Site Status COMPLETED

Local Institution - 4306

Milan, , Italy

Site Status COMPLETED

Local Institution - 4307

Palermo, , Italy

Site Status WITHDRAWN

Local Institution - 4303

Pordenone, , Italy

Site Status COMPLETED

Local Institution - 4304

Ravenna, , Italy

Site Status NOT_YET_RECRUITING

Local Institution - 4305

Reggio Emilia, , Italy

Site Status COMPLETED

Local Institution - 4308

Roma, , Italy

Site Status COMPLETED

Local Institution - 4302

Terni, , Italy

Site Status COMPLETED

Ehime University Hospital

Tōon, Ehime, Japan

Site Status RECRUITING

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Kanagawa cancer center

Yokohama, Kanagawa, Japan

Site Status RECRUITING

Osaka City General Hospital

Osaka, Osaka, Japan

Site Status RECRUITING

National Cancer Center Hospital.

Chuo-ku, Tokyo, Japan

Site Status RECRUITING

Tottori University Hospital

Yonago, Tottori, Japan

Site Status RECRUITING

National Cancer Center Hospital East

Kashiwa, , Japan

Site Status RECRUITING

Nagoya University Hospital

Nagoya, , Japan

Site Status RECRUITING

Osaka International Cancer institute

Osaka, , Japan

Site Status RECRUITING

Local Institution - 4502

Amsterdam, , Netherlands

Site Status COMPLETED

Local Institution - 4501

Groningen, , Netherlands

Site Status COMPLETED

Ośrodek Badań Klinicznych Wczesnych Faz, Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Site Status RECRUITING

Local Institution - 4604

Lublin, , Poland

Site Status COMPLETED

Local Institution - 4605

Poznan, , Poland

Site Status COMPLETED

Local Institution - 4603

Szczecin, , Poland

Site Status COMPLETED

Local Institution - 4602

Warsaw, , Poland

Site Status COMPLETED

Local Institution - 6401

Singapore, , Singapore

Site Status COMPLETED

Local Institution - 6402

Singapore, , Singapore

Site Status COMPLETED

Local Institution - 3003

Seoul, Gangnam-gu, South Korea

Site Status COMPLETED

Local Institution - 6308

Hwasun-eup, Hwasun-gun, Jeollanam-do, South Korea

Site Status COMPLETED

Yonsei University Health System

Seoul, Seodaemun-gu, South Korea

Site Status RECRUITING

Local Institution - 3002

Seoul, Seoul Teugbyeolsi, South Korea

Site Status WITHDRAWN

Local Institution - 6301

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status COMPLETED

Local Institution - 6303

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status COMPLETED

Local Institution - 6306

Cheongju-si, , South Korea

Site Status COMPLETED

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Local Institution - 6302

Seoul, , South Korea

Site Status COMPLETED

Local Institution - 6307

Seoul, , South Korea

Site Status COMPLETED

Local Institution - 6305

Seoul, , South Korea

Site Status COMPLETED

Local Institution - 6304

Seoul, , South Korea

Site Status COMPLETED

Local Institution - 4102

Barcelona, , Spain

Site Status COMPLETED

Local Institution - 4101

Barcelona, , Spain

Site Status COMPLETED

Local Institution - 4106

Madrid, , Spain

Site Status COMPLETED

Local Institution - 4104

Madrid, , Spain

Site Status COMPLETED

Local Institution - 4103

Madrid, , Spain

Site Status COMPLETED

Local Institution - 4105

Madrid, , Spain

Site Status COMPLETED

Clinica Universidad de Navarra

Pamplona, , Spain

Site Status RECRUITING

Instituto Valenciano de Oncología (IVO) - Unidad de Investigación Clínica FINCIVO

Valencia, , Spain

Site Status RECRUITING

Local Institution - 6201

Taiepi, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Local Institution - 6203

Tainan City, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Local Institution - 6202

Taipei, , Taiwan

Site Status COMPLETED

Local Institution - 4401

London, , United Kingdom

Site Status COMPLETED

Local Institution - 4402

London, , United Kingdom

Site Status COMPLETED

Local Institution - 4404

London, , United Kingdom

Site Status COMPLETED

Local Institution - 4403

Manchester, , United Kingdom

Site Status COMPLETED

Local Institution - 4405

Sutton, , United Kingdom

Site Status COMPLETED

Countries

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United States Australia Belgium Canada China Denmark France Germany Hong Kong Hungary Italy Japan Netherlands Poland Singapore South Korea Spain Taiwan United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

BMS Study Connect Contact Center www.BMSStudyConnect.com

Role: CONTACT

855-907-3286

First line of the email MUST contain the NCT# and Site #.

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Misako Nagasaka, Site 1001

Role: primary

714-456-5153

Site 1003

Role: primary

Site 2116

Role: primary

Site 1004

Role: primary

Alexander Drilon, Site 1002

Role: primary

646-888-4206

Jian Fang, Site 6703

Role: primary

868613701224460

Yong He, Site 6736

Role: primary

13908338998

Jingxun Wu, Site 6708

Role: primary

15160085395

Jinji Yang, Site 6747

Role: primary

Yan Yu, Site 6722

Role: primary

13904505825

Xiaorong Dong, Site 6710

Role: primary

13986252286

Nong Yang, Site 6718

Role: primary

13055193557

Xiang Wang, Site 6732

Role: primary

Meili Sun, Site 6720

Role: primary

18953116532

Ying Cheng, Site 6717

Role: primary

8613943012851

Jiuwei Cui, Site 6714

Role: primary

8615843073215

Rui Ma, Site 6742

Role: primary

Haichuan Su, Site 6754

Role: primary

Junping Zhang, Site 6749

Role: primary

13994204099

Wenxiu Yao, Site 6728

Role: primary

18908178836

Liang Gong, Site 6716

Role: primary

+8613983965893

Yiping Zhang, Site 6721

Role: primary

Jie Meng, Site 6734

Role: primary

Feng Luo, Site 6724

Role: primary

+8618980601766

Jianying Zhou, Site 6712

Role: primary

8613505719970

Yueyin Pan, Site 6704

Role: primary

8613805695536

Liyan Jiang, Site 6709

Role: primary

Shun Lu, Site 6701

Role: primary

8613601813062

Guohua Yu, Site 6727

Role: primary

Xiufeng Hu, Site 6715

Role: primary

+8618339920984

Esma Saada-Bouzid, Site 4205

Role: primary

33492031514

Nicolas Isambert, Site 4208

Role: primary

+3333380737753

Benjamin Besse, Site 4202

Role: primary

33142114211

Site 4304

Role: primary

Naoyuki Nogami, Site 6609

Role: primary

Jun Sakakibara, Site 6607

Role: primary

+81-11-716-1161

Kato Terufumi, Site 6603

Role: primary

+8145520222200000000

Haruko Daga, Site 6605

Role: primary

81669293269

Yasushi Goto, Site 6604

Role: primary

+819043996497

Kodani Masahiro, Site 6606

Role: primary

Koichi Goto, Site 6601

Role: primary

81471331111

Yuichi Ando, Site 6608

Role: primary

81527412111

Motohiro 基裕 Tamiya 田宮, Site 6602

Role: primary

81669451181

Rafal Dziadziuszko, Site 4601

Role: primary

48585844571

Byoung Chul Cho, Site 3002

Role: primary

82222288126

Dong-Wan Kim, Site 3001

Role: primary

+821027324635

Ignacio Gil Bazo, Site 4108

Role: primary

+34948255400

Angel Guerrero, Site 4107

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Drilon A, Camidge DR, Lin JJ, Kim SW, Solomon BJ, Dziadziuszko R, Besse B, Goto K, de Langen AJ, Wolf J, Lee KH, Popat S, Springfeld C, Nagasaka M, Felip E, Yang N, Velcheti V, Lu S, Kao S, Dooms C, Krebs MG, Yao W, Beg MS, Hu X, Moro-Sibilot D, Cheema P, Stopatschinskaja S, Mehta M, Trone D, Graber A, Sims G, Yuan Y, Cho BC; TRIDENT-1 Investigators. Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024 Jan 11;390(2):118-131. doi: 10.1056/NEJMoa2302299.

Reference Type DERIVED
PMID: 38197815 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32269053 (View on PubMed)

Drilon A, Ou SI, Cho BC, Kim DW, Lee J, Lin JJ, Zhu VW, Ahn MJ, Camidge DR, Nguyen J, Zhai D, Deng W, Huang Z, Rogers E, Liu J, Whitten J, Lim JK, Stopatschinskaja S, Hyman DM, Doebele RC, Cui JJ, Shaw AT. Repotrectinib (TPX-0005) Is a Next-Generation ROS1/TRK/ALK Inhibitor That Potently Inhibits ROS1/TRK/ALK Solvent- Front Mutations. Cancer Discov. 2018 Oct;8(10):1227-1236. doi: 10.1158/2159-8290.CD-18-0484. Epub 2018 Aug 9.

Reference Type DERIVED
PMID: 30093503 (View on PubMed)

Related Links

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Other Identifiers

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CA127-1024

Identifier Type: OTHER

Identifier Source: secondary_id

TPX-0005-01

Identifier Type: OTHER

Identifier Source: secondary_id

CA127-1024

Identifier Type: -

Identifier Source: org_study_id

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