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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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 12 Years and Over |
Gender | All |
PHASE 1.Key
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03093116 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 1/Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Turning Point Therapeutics, Inc. |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Bristol-Myers Squibb |
Principal Investigator Affiliation | Bristol-Myers Squibb |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Poland, Singapore, Spain, Taiwan, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Locally Advanced Solid Tumors, Metastatic Solid Tumors |
Study Website: | View Trial Website |
In Phase 2, study subjects will be enrolled into 6 distinct expansion (EXP) cohorts:
Experimental: 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
Drug: - Oral repotrectinib (TPX-0005)
Oral repotrectinib (TPX-0005) capsules.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Completed
Address
Local Institution - 2129
Duarte, California, 91010
Status
Completed
Address
Local Institution - 2120
Glendale, California, 91206
Status
Withdrawn
Address
Local Institution - 2136
La Jolla, California, 92037
Status
Completed
Address
Local Institution - 2114
La Jolla, California, 92093
Status
Completed
Address
Local Institution - 2121
Long Beach, California, 90813
Status
Completed
Address
Local Institution - 2101
Orange, California, 92868
Status
Recruiting
Address
University of California Irvine Medical Center
Orange, California, 92868
Status
Completed
Address
Local Institution - 2126
Santa Rosa, California, 95403
Status
Not yet recruiting
Address
Local Institution - 1003
Aurora, Colorado, 80045
Status
Completed
Address
Local Institution - 2103
Aurora, Colorado, 80045
Status
Completed
Address
Local Institution - 2106
Washington, District of Columbia, 20007
Status
Completed
Address
Local Institution - 2110
Washington, District of Columbia, 20016
Status
Completed
Address
Local Institution - 2128
Hollywood, Florida, 33021
Status
Completed
Address
Local Institution - 2113
Tampa, Florida, 33612
Status
Completed
Address
Local Institution - 2139
Athens, Georgia, 30607
Status
Completed
Address
Local Institution - 2134
Columbus, Georgia, 31904
Status
Completed
Address
Local Institution - 2125
Chicago, Illinois, 60637
Status
Completed
Address
Local Institution - 2142
Peoria, Illinois, 61615
Status
Not yet recruiting
Address
Local Institution - 2116
New Orleans, Louisiana, 70121
Status
Completed
Address
Local Institution - 2133
Baltimore, Maryland, 21210
Status
Completed
Address
Local Institution - 2104
Boston, Massachusetts, 02114
Status
Not yet recruiting
Address
Local Institution - 1004
Boston, Massachusetts, 02214
Status
Completed
Address
Local Institution - 2131
Boston, Massachusetts, 02215
Status
Completed
Address
Local Institution - 2105
Ann Arbor, Michigan, 48109
Status
Completed
Address
Local Institution - 2111
Detroit, Michigan, 48201
Status
Completed
Address
Local Institution - 2140
Detroit, Michigan, 48202-2608
Status
Completed
Address
Local Institution - 2132
Saint Paul, Minnesota, 55101
Status
Completed
Address
Local Institution - 2147
Bolivar, Missouri, 65613
Status
Completed
Address
Local Institution - 2115
Saint Louis, Missouri, 63110
Status
Completed
Address
Local Institution - 2122
New Brunswick, New Jersey, 08901
Status
Completed
Address
Local Institution - 2117
New York, New York, 10016
Status
Completed
Address
Local Institution - 2102
New York, New York, 10065
Status
Recruiting
Address
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Status
Completed
Address
Local Institution - 2144
Goldsboro, North Carolina, 27534
Status
Completed
Address
Local Institution - 2112
Canton, Ohio, 44718
Status
Completed
Address
Local Institution - 2143
Cincinnati, Ohio, 45220
Status
Completed
Address
Local Institution - 2109
Cleveland, Ohio, 44195
Status
Completed
Address
Local Institution - 2123
Columbus, Ohio, 43210
Status
Completed
Address
Local Institution - 2119
Toledo, Ohio, 43614
Status
Completed
Address
Local Institution - 2108
Philadelphia, Pennsylvania, 19111-2497
Status
Completed
Address
Local Institution - 2148
Memphis, Tennessee, 38120
Status
Completed
Address
Local Institution - 2130
Dallas, Texas, 75390
Status
Completed
Address
Local Institution - 2127
Houston, Texas, 77030
Status
Completed
Address
Local Institution - 2138
Houston, Texas, 77030
Status
Completed
Address
Local Institution - 2146
Kingwood, Texas, 77339
Status
Completed
Address
Local Institution - 2137
Fairfax, Virginia, 22031
Status
Completed
Address
Local Institution - 2107
Seattle, Washington, 98109
Status
Withdrawn
Address
Local Institution - 2141
Tacoma, Washington, 98405
Status
Completed
Address
Local Institution - 2145
Appleton, Wisconsin, 54911
Status
Completed
Address
Local Institution - 6102
Camperdown, New South Wales, 2050
Status
Completed
Address
Local Institution - 6103
Adelaide, South Australia, 5042
Status
Completed
Address
Local Institution - 6101
Melbourne, Victoria, 3000
Status
Completed
Address
Local Institution - 3301
East Melbourne, , 3002
Status
Completed
Address
Local Institution - 4802
Antwerp, , 2650
Status
Completed
Address
Local Institution - 4801
Leuven, , 3000
Status
Completed
Address
Local Institution - 2202
Edmonton, Alberta, T6G 1Z2
Status
Withdrawn
Address
Local Institution - 2205
Vancouver, British Columbia, V5Z 4E7
Status
Completed
Address
Local Institution - 2201
Toronto, Ontario, M5G 2M9
Status
Active, not recruiting
Address
Local Institution - 6503
Toronto, Ontario, M5G 2M9
Status
Completed
Address
Local Institution - 2203
Ontario, , L6R 37R
Status
Completed
Address
Local Institution - 2204
Ottawa, , K1H 8L6
Status
Completed
Address
Local Institution - 6702
Beijing, Beijing, 100021
Status
Recruiting
Address
Beijing Cancer hospital
Beijing, Beijing, 100142
Status
Recruiting
Address
Daping Hospital, the Third Affiliated Hospital of Third Military Medical University /Cancer Center
Daping, Chongqing, 00000
Status
Completed
Address
Local Institution - 6719
Fuzhou, Fujian, 000000
Status
Recruiting
Address
The First Affiliated hospital of Xiamen University-oncology
Xiamen, Fujian, 361003
Status
Recruiting
Address
Guangdong Provincial People'S Hospital
Guangzhou, Guangdong, 510120
Status
Completed
Address
Local Institution - 6733
Guangzhou, Guangdong, 510120
Status
Active, not recruiting
Address
Local Institution - 6505
Shenzhen, Guangdong, 518053
Status
Recruiting
Address
The Affiliated Tumor Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081
Status
Active, not recruiting
Address
Local Institution - 6504
Shatin, Hong Kong, 999077
Status
Recruiting
Address
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology/Cancer Center Department
Wuhan, Hubei, 430022
Status
Completed
Address
Local Institution - 6705
Changsha, Hunan, 410011
Status
Recruiting
Address
Hunan Cancer Hospital-thoracic oncology II
Changsha, Hunan, 410013
Status
Completed
Address
Local Institution - 6748
Nanjing, Jiangsu, 210008
Status
Recruiting
Address
XuZhou Central Hospital/Oncology Department
Xuzhou City, Jiangsu, 00000
Status
Recruiting
Address
Jilin Cancer Hospital/Medical Oncology Department
Changchun, Jilin, 130012
Status
Recruiting
Address
Jilin Cancer Hospital/Medical Oncology Department
Changchun, Jilin, 130012
Status
Recruiting
Address
The first hospital of Jilin university-Oncology Department
Changchun, Jilin, 130021
Status
Recruiting
Address
Liaoning Cancer Hospital
Shenyang, Liaoning, 110801
Status
Recruiting
Address
Tangdu Hospital
Xi'an, Shan3xi, 710038
Status
Recruiting
Address
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Status
Recruiting
Address
Sichuan Cancer Hospital/Medical Oncology Department
Chengdu City, Sichuan, 00000
Status
Recruiting
Address
The First Hospital Affiliated To AMU - Southwest Hospital
Chongqing, Sichuan, 400030
Status
Completed
Address
Local Institution - 6725
Hangzhou, Zhejiang, 310016
Status
Recruiting
Address
Zhejiang Cancer Hospital-Oncology
Hangzhou, Zhejiang, 310022
Status
Recruiting
Address
The Third Xiangya Hospital of Central South University/Department of Respiratory and Critical Care Medicine
Changsha, , 00000
Status
Recruiting
Address
West China Hospital Sichuan University/Lung cancer center
Chengdu, , 00000
Status
Recruiting
Address
The First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou, , 310003
Status
Recruiting
Address
Anhui Provincial Hospital
Hefei, , 230001
Status
Recruiting
Address
Shanghai Chest Hospital
Shanghai, , 200030
Status
Recruiting
Address
Shanghai Chest Hospital
Shanghai, , 200030
Status
Recruiting
Address
Weifang People's Hospital/Medical Oncology Department
Weifang City, , 00000
Status
Recruiting
Address
Henan Cancer Hospital/The 1st pneumology department
Zhengzhou, , 00000
Status
Completed
Address
Local Institution - 4901
Copenhagen, , 2100
Status
Completed
Address
Local Institution - 4201
Marseille, Bouches-du-Rhône, 13005
Status
Completed
Address
Local Institution - 4207
Brest, , 29200
Status
Completed
Address
Local Institution - 4204
Dijon Cedex, , 21079
Status
Completed
Address
Local Institution - 4206
Grenoble Cedex 9, , 38043
Status
Recruiting
Address
Centre Antoine-Lacassagne
Nice, , 06189
Status
Recruiting
Address
Chu Poitiers
Poitiers, , 86000
Status
Completed
Address
Local Institution - 4203
St Mande, , 94163
Status
Recruiting
Address
Institute Gustave Roussy
Villejuif, , 98405
Status
Completed
Address
Local Institution - 4704
Berlin, , 13125
Status
Completed
Address
Local Institution - 4703
Dresden, , 01307
Status
Completed
Address
Local Institution - 4702
Heidelberg, , 69120
Status
Completed
Address
Local Institution - 4701
Koln, , 50937
Status
Active, not recruiting
Address
Local Institution - 6502
Hong Kong, , 0
Status
Active, not recruiting
Address
Local Institution - 6501
Hong Kong, ,
Status
Completed
Address
Local Institution - 5101
Budapest, , 1083
Status
Completed
Address
Local Institution - 5103
Budapest, , 1121
Status
Completed
Address
Local Institution - 4301
Milano, MI, 20133
Status
Completed
Address
Local Institution - 4306
Milano, , 20122
Status
Withdrawn
Address
Local Institution - 4307
Palermo, , 90146
Status
Completed
Address
Local Institution - 4303
Pordenone, , 33081
Status
Not yet recruiting
Address
Local Institution - 4304
Ravenna, , 48121
Status
Completed
Address
Local Institution - 4305
Reggio Emilia, , 42123
Status
Completed
Address
Local Institution - 4308
Roma, , 144
Status
Completed
Address
Local Institution - 4302
Terni, , 05100
Status
Recruiting
Address
Ehime University Hospital
Toon, Ehime, 791-0295
Status
Recruiting
Address
Hokkaido University Hospital
Sapporo-shi, Hokkaido, 0608648
Status
Recruiting
Address
Kanagawa cancer center
Yokohama, Kanagawa, 2418515
Status
Recruiting
Address
Osaka City General Hospital
Osaka-shi, Osaka, 5340021
Status
Recruiting
Address
National Cancer Center Hospital.
Chuo-ku, Tokyo, 1040045
Status
Recruiting
Address
Tottori University Hospital
Yonago, Tottori, 683-8504
Status
Recruiting
Address
National Cancer Center Hospital East
Kashiwa, , 277-8577
Status
Recruiting
Address
Nagoya University Hospital
Nagoya-shi, , 466-8560
Status
Recruiting
Address
Osaka International Cancer institute
Osaka, , 5418567
Status
Completed
Address
Local Institution - 3003
Seoul, Gangnam-gu, 06351
Status
Completed
Address
Local Institution - 6308
Hwasun-eup, Hwasun-gun, Jeonnam, 519-763
Status
Recruiting
Address
Yonsei University Health System
Seoul, Seodaemun-gu, 03722
Status
Withdrawn
Address
Local Institution - 3002
Seoul, Seoul Teugbyeolsi, 03080
Status
Completed
Address
Local Institution - 6301
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Status
Completed
Address
Local Institution - 6303
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Status
Completed
Address
Local Institution - 6306
Cheongju-si, , 28644
Status
Recruiting
Address
Seoul National University Hospital
Seoul, , 03080
Status
Completed
Address
Local Institution - 6302
Seoul, , 03722
Status
Completed
Address
Local Institution - 6307
Seoul, , 05030
Status
Completed
Address
Local Institution - 6305
Seoul, , 05505
Status
Completed
Address
Local Institution - 6304
Seoul, , 06591
Status
Completed
Address
Local Institution - 4502
Amsterdam, , 1066 CX
Status
Completed
Address
Local Institution - 4501
Groningen, , 9713 GZ
Status
Recruiting
Address
Ośrodek Badań Klinicznych Wczesnych Faz, Uniwersyteckie Centrum Kliniczne
Gdańsk, , 80-214
Status
Completed
Address
Local Institution - 4604
Lublin, , 20-609
Status
Completed
Address
Local Institution - 4605
Poznań, , 60-693
Status
Completed
Address
Local Institution - 4603
Szczecin, , 70-784
Status
Completed
Address
Local Institution - 4602
Warszawa, , 02-781
Status
Completed
Address
Local Institution - 6401
Singapore, , 119074
Status
Completed
Address
Local Institution - 6402
Singapore, , 169610
Status
Completed
Address
Local Institution - 4102
Barcelona, , 08028
Status
Completed
Address
Local Institution - 4101
Barcelona, , 8035
Status
Completed
Address
Local Institution - 4106
Madrid, , 28033
Status
Completed
Address
Local Institution - 4104
Madrid, , 28040
Status
Completed
Address
Local Institution - 4103
Madrid, , 28041
Status
Completed
Address
Local Institution - 4105
Madrid, , 28050
Status
Recruiting
Address
Clinica Universidad de Navarra
Pamplona, , 31008
Status
Recruiting
Address
Instituto Valenciano de Oncología (IVO) - Unidad de Investigación Clínica FINCIVO
Valencia, , 46009
Status
Active, not recruiting
Address
Local Institution - 6201
Taiepi, , 100
Status
Active, not recruiting
Address
Local Institution - 6203
Tainan, , 704
Status
Completed
Address
Local Institution - 6202
Taipei, , 10449
Status
Completed
Address
Local Institution - 4401
London, , SW3 6JJ
Status
Completed
Address
Local Institution - 4402
London, , W12 OHS
Status
Completed
Address
Local Institution - 4404
London, , W1G 6AD
Status
Completed
Address
Local Institution - 4403
Manchester, , M20 4BX
Status
Completed
Address
Local Institution - 4405
Sutton, , SM2 5PT