RecruitingPhase 1Phase 2NCT03093116

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

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)

Sponsor

Turning Point Therapeutics, Inc.

Enrollment

500 participants

Start Date

Mar 7, 2017

Study Type

INTERVENTIONAL

Conditions

Metastatic Solid Tumors Locally Advanced Solid Tumors

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.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This trial tests repotrectinib (TPX-0005) — a targeted drug designed to block specific cancer-driving gene fusions (ALK, ROS1, or NTRK1-3) — in people with advanced solid tumors that carry one of these genetic changes, including those whose cancer has stopped responding to earlier targeted therapies. **You may be eligible if...** - You are 18 or older (or 12 and older for Phase 2) with an advanced solid tumor that has been confirmed to carry an ALK, ROS1, or NTRK genetic rearrangement - You are in good physical condition (ECOG 0–1) - Your cancer has measurable disease visible on a scan - Your blood counts, kidney, and liver function are within acceptable ranges - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - Your brain metastases are causing symptoms - You have had major surgery within 4 weeks, or radiation within 2 weeks of starting the study - You have significant heart disease (such as a recent heart attack, heart failure, or irregular heartbeat) - You have a condition that prevents you from absorbing oral medications (such as Crohn's disease or severe diarrhea) - You have significant nerve damage (peripheral neuropathy grade 2 or higher) - You have a serious active infection, including HIV - You are currently enrolled in another therapeutic clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral repotrectinib (TPX-0005)

Oral repotrectinib (TPX-0005) capsules.

Locations(165)

Local Institution - 2129

Duarte, California, United States

Local Institution - 2120

Glendale, California, United States

Local Institution - 2136

La Jolla, California, United States

Local Institution - 2114

La Jolla, California, United States

Local Institution - 2121

Long Beach, California, United States

Local Institution - 1001

Orange, California, United States

Local Institution - 2101

Orange, California, United States

St Joseph Heritage Healthcare

Santa Rosa, California, United States

Local Institution - 1003

Aurora, Colorado, United States

Local Institution - 2103

Aurora, Colorado, United States

Local Institution - 2106

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

Local Institution - 2110

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

Memorial Healthcare System

Hollywood, Florida, United States

Local Institution - 2113

Tampa, Florida, United States

University Cancer and Blood Center

Athens, Georgia, United States

Local Institution - 2134

Columbus, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Local Institution - 2142

Peoria, Illinois, United States

Local Institution - 2116

New Orleans, Louisiana, United States

Local Institution - 2133

Baltimore, Maryland, United States

Massachusetts General Hospital,

Boston, Massachusetts, United States

Local Institution - 1004

Boston, Massachusetts, United States

Local Institution - 2131

Boston, Massachusetts, United States

Local Institution - 2105

Ann Arbor, Michigan, United States

Local Institution - 2111

Detroit, Michigan, United States

Local Institution - 2140

Detroit, Michigan, United States

Local Institution - 2132

Saint Paul, Minnesota, United States

Local Institution - 2147

Bolivar, Missouri, United States

Washington University Infusion Center Pharmacy

St Louis, Missouri, United States

Local Institution - 2122

New Brunswick, New Jersey, United States

Local Institution - 2117

New York, New York, United States

Local Institution - 1002

New York, New York, United States

Local Institution - 2102

New York, New York, United States

Local Institution - 2144

Goldsboro, North Carolina, United States

Local Institution - 2112

Canton, Ohio, United States

Local Institution - 2143

Cincinnati, Ohio, United States

Local Institution - 2109

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Local Institution - 2119

Toledo, Ohio, United States

Local Institution - 2108

Philadelphia, Pennsylvania, United States

Baptist Memorial Hospital Baptist Cancer Center

Memphis, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Local Institution - 2127

Houston, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Local Institution - 2146

Kingwood, Texas, United States

Local Institution - 2137

Fairfax, Virginia, United States

Local Institution - 2107

Seattle, Washington, United States

Local Institution - 2141

Tacoma, Washington, United States

Local Institution - 2145

Appleton, Wisconsin, United States

Chris O'Brien LifeHouse

Camperdown, New South Wales, Australia

Local Institution - 6103

Adelaide, South Australia, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Local Institution - 3301

East Melbourne, Australia

Local Institution - 4802

Antwerp, Belgium

Local Institution - 4801

Leuven, Belgium

Local Institution - 2202

Edmonton, Alberta, Canada

Local Institution - 2205

Vancouver, British Columbia, Canada

Local Institution - 2201

Toronto, Ontario, Canada

Local Institution - 6503

Toronto, Ontario, Canada

Local Institution - 2203

Ontario, Canada

Local Institution - 2204

Ottawa, Canada

Local Institution - 6702

Beijing, Beijing Municipality, China

Beijing Cancer hospital

Beijing, Beijing Municipality, China

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

Daping, Chongqing Municipality, China

Local Institution - 6719

Fuzhou, Fujian, China

The First Affiliated hospital of Xiamen University-oncology

Xiamen, Fujian, China

Guangdong Provincial People'S Hospital

Guangzhou, Guangdong, China

Local Institution - 6733

Guangzhou, Guangdong, China

Local Institution - 6505

Shenzhen, Guangdong, China

The Affiliated Tumor Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Local Institution - 6504

Shatin, HONG KONG, China

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

Wuhan, Hubei, China

Local Institution - 6705

Changsha, Hunan, China

Hunan Cancer Hospital-thoracic oncology II

Changsha, Hunan, China

Local Institution - 6748

Nanjing, Jiangsu, China

XuZhou Central Hospital/Oncology Department

Xuzhou, Jiangsu, China

Jilin Cancer Hospital/Medical Oncology Department

Changchun, Jilin, China

Jilin Cancer Hospital/Medical Oncology Department

Changchun, Jilin, China

The first hospital of Jilin university-Oncology Department

Changchun, Jilin, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Tangdu Hospital

Xi'an, Shan3xi, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Sichuan Cancer Hospital/Medical Oncology Department

Chengdu, Sichuan, China

The First Hospital Affiliated To AMU - Southwest Hospital

Chongqing, Sichuan, China

Local Institution - 6725

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital-Oncology

Hangzhou, Zhejiang, China

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

Changsha, China

West China Hospital Sichuan University/Lung cancer center

Chengdu, China

The First Affiliated Hospital - Zhejiang University School of Medicine

Hangzhou, China

Anhui Provincial Hospital

Hefei, China

Shanghai Chest Hospital

Shanghai, China

Shanghai Chest Hospital

Shanghai, China

Weifang People's Hospital/Medical Oncology Department

Weifang, China

Henan Cancer Hospital/The 1st pneumology department

Zhengzhou, China

Local Institution - 4901

Copenhagen, Denmark

Local Institution - 4201

Marseille, Bouches-du-Rhône, France

Local Institution - 4207

Brest, France

Centre Georges-Francois Leclerc

Dijon, France

Centre Hospitalier Universitarie Grenoble Alpes (Chuga)

Grenoble, France

Centre Antoine-Lacassagne

Nice, France

Local Institution - 4208

Poitiers, France

Local Institution - 4203

Saint-Mandé, France

Institute Gustave Roussy

Villejuif, France

Local Institution - 4704

Berlin, Germany

Local Institution - 4701

Cologne, Germany

Local Institution - 4703

Dresden, Germany

Local Institution - 4702

Heidelberg, Germany

Local Institution - 6502

Hong Kong, Hong Kong

Local Institution - 6501

Hong Kong, Hong Kong

Local Institution - 5101

Budapest, Hungary

Local Institution - 5103

Budapest, Hungary

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, MI, Italy

Local Institution - 4306

Milan, Italy

Local Institution - 4307

Palermo, Italy

Centro di Riferimento Oncologico

Pordenone, Italy

Local Institution - 4304

Ravenna, Italy

Local Institution - 4305

Reggio Emilia, Italy

IRCCS Istituto Regina Elena Oncologia Medica 2

Roma, Italy

Local Institution - 4302

Terni, Italy

Ehime University Hospital

Tōon, Ehime, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Kanagawa cancer center

Yokohama, Kanagawa, Japan

Osaka City General Hospital

Osaka, Osaka, Japan

National Cancer Center Hospital.

Chuo-ku, Tokyo, Japan

Tottori University Hospital

Yonago, Tottori, Japan

National Cancer Center Hospital East

Kashiwa, Japan

Nagoya University Hospital

Nagoya, Japan

Osaka International Cancer institute

Osaka, Japan

Local Institution - 4502

Amsterdam, Netherlands

Local Institution - 4501

Groningen, Netherlands

Ośrodek Badań Klinicznych Wczesnych Faz, Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Local Institution - 4604

Lublin, Poland

Local Institution - 4605

Poznan, Poland

Local Institution - 4603

Szczecin, Poland

Local Institution - 4602

Warsaw, Poland

National University Hospital

Singapore, Singapore

National Cancer Center Singapore

Singapore, Singapore

Local Institution - 3003

Seoul, Gangnam-gu, South Korea

Chonnam National University Hwasun Hospital

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

Local Institution - 3002

Seoul, Seodaemun-gu, South Korea

Local Institution - 3002

Seoul, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 6306

Cheongju-si, South Korea

Local Institution - 3001

Seoul, South Korea

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Local Institution - 6307

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Local Institution - 6304

Seoul, South Korea

Local Institution - 4102

Barcelona, Spain

Hospital Unversitario Val D'Hebrón

Barcelona, Spain

Local Institution - 4106

Madrid, Spain

START Madrid-FJD

Madrid, Spain

Local Institution - 4103

Madrid, Spain

Hospital Universitario HM Sanchinarro CIOCC

Madrid, Spain

Local Institution - 4108

Pamplona, Spain

Local Institution - 4107

Valencia, Spain

Local Institution - 6201

Taiepi, Taiwan

Local Institution - 6203

Tainan, Taiwan

Local Institution - 6202

Taipei, Taiwan

Local Institution - 4401

London, United Kingdom

Local Institution - 4402

London, United Kingdom

Local Institution - 4404

London, United Kingdom

Local Institution - 4403

Manchester, United Kingdom

Local Institution - 4405

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT03093116

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