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
Interventions
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.
Keywords
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
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