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Spots Global Cancer Trial Database for A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

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Trial Identification

Brief Title: 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 ID: NCT03093116

Study Description

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

Minimum Age: 12 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

City Of Hope, Duarte, California, United States

Adventist Health Glendale, Glendale, California, United States

UC San Diego Health, La Jolla, California, United States

Pacific Shores Medical Group, Long Beach, California, United States

UC Irvine Medical Center, Orange, California, United States

St Joseph Heritage Healthcare, Santa Rosa, California, United States

University Of Colorado Denver, Aurora, Colorado, United States

Georgetown University Medical Center - Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Washington, District of Columbia, United States

Memorial Healthcare System, Hollywood, Florida, United States

Moffitt Cancer Center, Tampa, Florida, United States

University Cancer and Blood Center, Athens, Georgia, United States

Colombus Regional Research Institute, Columbus, Georgia, United States

University of Chicago, Chicago, Illinois, United States

Illinois Cancer Care, Peoria, Illinois, United States

University of Maryland Medical Center, Baltimore, Maryland, United States

Massachusetts General Hospital,, Boston, Massachusetts, United States

Dana Farber Cancer Institute., Boston, Massachusetts, United States

University Of Michigan, Ann Arbor, Michigan, United States

Karmanos Cancer Institute, Detroit, Michigan, United States

Henry Ford Transplant Institute, Detroit, Michigan, United States

Regions Hospital - Cancer Care Center, Saint Paul, Minnesota, United States

Central Care Cancer Center, Bolivar, Missouri, United States

Washington University Infusion Center Pharmacy, Saint Louis, Missouri, United States

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Laura & Isaac Perlmutter Cancer Center, New York, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Southeastern Medical Oncology Center, Goldsboro, North Carolina, United States

Gabrail Cancer Center, Canton, Ohio, United States

Trihealth Cancer Institute, Cincinnati, Ohio, United States

Cleveland Clinic Main Campus, Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Baptist Memorial Hospital Baptist Cancer Center, Memphis, Tennessee, United States

UT Southwestern Medical Center, Dallas, Texas, United States

MD Anderson Cancer Center, Houston, Texas, United States

Oncology Consultants, P.A., Houston, Texas, United States

Lumi Research, Kingwood, Texas, United States

Virginia Cancer Specialists, PC, Fairfax, Virginia, United States

University of Washington-Seattle Cancer Care Alliance, Seattle, Washington, United States

ThedaCare, Appleton, Wisconsin, United States

Local Institution - 6102, Camperdown, New South Wales, Australia

Local Institution - 6103, Adelaide, South Australia, Australia

Local Institution - 6101, Melbourne, Victoria, 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, China

Beijing Cancer Hospital, Beijing, Beijing, China

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

The First Affiliated Hospital of Guangzhou Medical University-Pneumology department, 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

Local Institution - 6705, Changsha, Hunan, China

Hunan Cancer Hospital-thoracic oncology II, Changsha, Hunan, China

Nanjing Drum Tower hospital, Nanjing, Jiangsu, China

XuZhou Central Hospital/Oncology Department, Xuzhou City, Jiangsu, China

Local Institution - 6714, Changchun, Jilin, China

Local Institution - 6742, Shenyang, Liaoning, China

Tangdu Hospital, Xi'an, Shan3xi, China

Shanxi Bethune Hospital, Taiyuan, Shanxi, China

Sichuan Cancer Hospital/Medical Oncology Department, Chengdu City, Sichuan, China

Local Institution - 6716, Chongqing, Sichuan, China

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital-Oncology, Hangzhou, Zhejiang, China

Jilin Cancer Hospital/Medical Oncology Department, Changchun City, , China

Jilin Cancer Hospital/Medical Oncology Department, Changchun City, , 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

Local Institution - 6704, Hefei, , China

Shanghai Chest Hospital, Shanghai, , China

Shanghai Chest Hospital, Shanghai, , China

Weifang People's Hospital/Medical Oncology Department, Weifang City, , China

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

Local Institution - 4204, Dijon Cedex, , France

Local Institution - 4206, Grenoble Cedex 9, , France

Local Institution - 4205, Nice, , France

Local Institution - 4208, Poitiers, , France

Local Institution - 4203, St Mande, , France

Local Institution - 4202, Villejuif, , France

Local Institution - 4704, Berlin, , Germany

Local Institution - 4703, Dresden, , Germany

Local Institution - 4702, Heidelberg, , Germany

Local Institution - 4701, Koln, , 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

Local Institution - 4301, Milano, MI, Italy

Local Institution - 4306, Milano, , Italy

Local Institution - 4307, Palermo, , Italy

Local Institution - 4303, Pordenone, , Italy

Local Institution - 4305, Reggio Emilia, , Italy

Local Institution - 4308, Roma, , Italy

Local Institution - 4302, Terni, , Italy

Local Institution - 6609, Toon, Ehime, Japan

Local Institution - 6607, Sapporo-shi, Hokkaido, Japan

Local Institution - 6603, Yokohama, Kanagawa, Japan

Local Institution - 6605, Osaka-shi, Osaka, Japan

Local Institution - 6604, Chuo-ku, Tokyo, Japan

Local Institution - 6606, Yonago, Tottori, Japan

National Cancer Center Hospital East, Kashiwa, , Japan

Local Institution - 6608, Nagoya-shi, , Japan

Local Institution - 6602, Osaka, , Japan

Local Institution - 6308, Hwasun-eup, Hwasun-gun, Jeonnam, Korea, Republic of

Local Institution - 6301, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Local Institution - 6303, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Local Institution - 6306, Cheongju-si, , Korea, Republic of

Local Institution - 6302, Seoul, , Korea, Republic of

Local Institution - 6307, Seoul, , Korea, Republic of

Local Institution - 6305, Seoul, , Korea, Republic of

Local Institution - 6304, Seoul, , Korea, Republic of

Local Institution - 4502, Amsterdam, , Netherlands

Local Institution - 4501, Groningen, , Netherlands

Local Institution - 4601, Gdańsk, , Poland

Local Institution - 4604, Lublin, , Poland

Local Institution - 4605, Poznań, , Poland

Local Institution - 4603, Szczecin, , Poland

Local Institution - 4602, Warszawa, , Poland

Local Institution - 6401, Singapore, , Singapore

Local Institution - 6402, Singapore, , Singapore

Local Institution - 4102, Barcelona, , Spain

Local Institution - 4101, Barcelona, , Spain

Local Institution - 4106, Madrid, , Spain

Local Institution - 4104, Madrid, , Spain

Local Institution - 4103, Madrid, , Spain

Local Institution - 4105, 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

Contact Details

Name: Bristol-Myers Squibb

Affiliation: Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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