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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, Netherlands, Poland, Singapore, South Korea, 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 5344147, California 5332921, 91010
Status
Completed
Address
Local Institution - 2120
Glendale 5352423, California 5332921, 91206
Status
Withdrawn
Address
Local Institution - 2136
La Jolla 5363943, California 5332921, 92037
Status
Completed
Address
Local Institution - 2114
La Jolla 5363943, California 5332921, 92093
Status
Completed
Address
Local Institution - 2121
Long Beach 5367929, California 5332921, 90813
Status
Completed
Address
Local Institution - 2101
Orange 5379513, California 5332921, 92868
Status
Recruiting
Address
University of California Irvine Medical Center
Orange 5379513, California 5332921, 92868
Status
Completed
Address
Local Institution - 2126
Santa Rosa 5393287, California 5332921, 95403
Status
Not yet recruiting
Address
Local Institution - 1003
Aurora 5412347, Colorado 5417618, 80045
Status
Completed
Address
Local Institution - 2103
Aurora 5412347, Colorado 5417618, 80045
Status
Completed
Address
Local Institution - 2106
Washington D.C. 4140963, District of Columbia 4138106, 20007
Status
Completed
Address
Local Institution - 2110
Washington D.C. 4140963, District of Columbia 4138106, 20016
Status
Completed
Address
Local Institution - 2128
Hollywood 4158928, Florida 4155751, 33021
Status
Completed
Address
Local Institution - 2113
Tampa 4174757, Florida 4155751, 33612
Status
Completed
Address
Local Institution - 2139
Athens 4180386, Georgia 4197000, 30607
Status
Completed
Address
Local Institution - 2134
Columbus 4188985, Georgia 4197000, 31904
Status
Completed
Address
Local Institution - 2125
Chicago 4887398, Illinois 4896861, 60637
Status
Completed
Address
Local Institution - 2142
Peoria 4905687, Illinois 4896861, 61615
Status
Not yet recruiting
Address
Local Institution - 2116
New Orleans 4335045, Louisiana 4331987, 70121
Status
Completed
Address
Local Institution - 2133
Baltimore 4347778, Maryland 4361885, 21210
Status
Completed
Address
Local Institution - 2104
Boston 4930956, Massachusetts 6254926, 02114
Status
Not yet recruiting
Address
Local Institution - 1004
Boston 4930956, Massachusetts 6254926, 02214
Status
Completed
Address
Local Institution - 2131
Boston 4930956, Massachusetts 6254926, 02215
Status
Completed
Address
Local Institution - 2105
Ann Arbor 4984247, Michigan 5001836, 48109
Status
Completed
Address
Local Institution - 2111
Detroit 4990729, Michigan 5001836, 48201
Status
Completed
Address
Local Institution - 2140
Detroit 4990729, Michigan 5001836, 48202-2608
Status
Completed
Address
Local Institution - 2132
Saint Paul 5045360, Minnesota 5037779, 55101
Status
Completed
Address
Local Institution - 2147
Bolivar 4377835, Missouri 4398678, 65613
Status
Completed
Address
Local Institution - 2115
St Louis 4407066, Missouri 4398678, 63110
Status
Completed
Address
Local Institution - 2122
New Brunswick 5101717, New Jersey 5101760, 08901
Status
Completed
Address
Local Institution - 2117
New York 5128581, New York 5128638, 10016
Status
Completed
Address
Local Institution - 2102
New York 5128581, New York 5128638, 10065
Status
Recruiting
Address
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638, 10065
Status
Completed
Address
Local Institution - 2144
Goldsboro 4468261, North Carolina 4482348, 27534
Status
Completed
Address
Local Institution - 2112
Canton 5149222, Ohio 5165418, 44718
Status
Completed
Address
Local Institution - 2143
Cincinnati 4508722, Ohio 5165418, 45220
Status
Completed
Address
Local Institution - 2109
Cleveland 5150529, Ohio 5165418, 44195
Status
Completed
Address
Local Institution - 2123
Columbus 4509177, Ohio 5165418, 43210
Status
Completed
Address
Local Institution - 2119
Toledo 5174035, Ohio 5165418, 43614
Status
Completed
Address
Local Institution - 2108
Philadelphia 4560349, Pennsylvania 6254927, 19111-2497
Status
Completed
Address
Local Institution - 2148
Memphis 4641239, Tennessee 4662168, 38120
Status
Completed
Address
Local Institution - 2130
Dallas 4684888, Texas 4736286, 75390
Status
Completed
Address
Local Institution - 2127
Houston 4699066, Texas 4736286, 77030
Status
Completed
Address
Local Institution - 2138
Houston 4699066, Texas 4736286, 77030
Status
Completed
Address
Local Institution - 2146
Kingwood 7534469, Texas 4736286, 77339
Status
Completed
Address
Local Institution - 2137
Fairfax 4758023, Virginia 6254928, 22031
Status
Completed
Address
Local Institution - 2107
Seattle 5809844, Washington 5815135, 98109
Status
Withdrawn
Address
Local Institution - 2141
Tacoma 5812944, Washington 5815135, 98405
Status
Completed
Address
Local Institution - 2145
Appleton 5244080, Wisconsin 5279468, 54911
Status
Completed
Address
Local Institution - 6102
Camperdown 2172563, New South Wales 2155400, 2050
Status
Completed
Address
Local Institution - 6103
Adelaide 2078025, South Australia 2061327, 5042
Status
Completed
Address
Local Institution - 6101
Melbourne 2158177, Victoria 2145234, 3000
Status
Completed
Address
Local Institution - 3301
East Melbourne 6952201, , 3002
Status
Completed
Address
Local Institution - 4802
Antwerp 2803138, , 2650
Status
Completed
Address
Local Institution - 4801
Leuven 2792482, , 3000
Status
Completed
Address
Local Institution - 2202
Edmonton 5946768, Alberta 5883102, T6G 1Z2
Status
Withdrawn
Address
Local Institution - 2205
Vancouver 6173331, British Columbia 5909050, V5Z 4E7
Status
Completed
Address
Local Institution - 2201
Toronto 6167865, Ontario 6093943, M5G 2M9
Status
Active, not recruiting
Address
Local Institution - 6503
Toronto 6167865, Ontario 6093943, M5G 2M9
Status
Completed
Address
Local Institution - 2203
Ontario, , L6R 37R
Status
Completed
Address
Local Institution - 2204
Ottawa 6094817, , K1H 8L6
Status
Completed
Address
Local Institution - 6702
Beijing 1816670, Beijing Municipality 2038349, 100021
Status
Recruiting
Address
Beijing Cancer hospital
Beijing 1816670, Beijing Municipality 2038349, 100142
Status
Recruiting
Address
Daping Hospital, the Third Affiliated Hospital of Third Military Medical University /Cancer Center
Daping 8397695, Chongqing Municipality 1814905, 00000
Status
Completed
Address
Local Institution - 6719
Fuzhou 1810821, Fujian 1811017, 000000
Status
Recruiting
Address
The First Affiliated hospital of Xiamen University-oncology
Xiamen 1790645, Fujian 1811017, 361003
Status
Recruiting
Address
Guangdong Provincial People'S Hospital
Guangzhou 1809858, Guangdong 1809935, 510120
Status
Completed
Address
Local Institution - 6733
Guangzhou 1809858, Guangdong 1809935, 510120
Status
Active, not recruiting
Address
Local Institution - 6505
Shenzhen 1795565, Guangdong 1809935, 518053
Status
Recruiting
Address
The Affiliated Tumor Hospital of Harbin Medical University
Harbin 2037013, Heilongjiang 2036965, 150081
Status
Active, not recruiting
Address
Local Institution - 6504
Shatin 1818920, HONG KONG, 999077
Status
Recruiting
Address
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology/Cancer Center Department
Wuhan 1791247, Hubei 1806949, 430022
Status
Completed
Address
Local Institution - 6705
Changsha 1815577, Hunan 1806691, 410011
Status
Recruiting
Address
Hunan Cancer Hospital-thoracic oncology II
Changsha 1815577, Hunan 1806691, 410013
Status
Completed
Address
Local Institution - 6748
Nanjing 1799962, Jiangsu 1806260, 210008
Status
Recruiting
Address
XuZhou Central Hospital/Oncology Department
Xuzhou 10630003, Jiangsu 1806260, 00000
Status
Recruiting
Address
Jilin Cancer Hospital/Medical Oncology Department
Changchun 2038180, Jilin 2036500, 130012
Status
Recruiting
Address
Jilin Cancer Hospital/Medical Oncology Department
Changchun 2038180, Jilin 2036500, 130012
Status
Recruiting
Address
The first hospital of Jilin university-Oncology Department
Changchun 2038180, Jilin 2036500, 130021
Status
Recruiting
Address
Liaoning Cancer Hospital
Shenyang 2034937, Liaoning 2036115, 110801
Status
Recruiting
Address
Tangdu Hospital
Xi'an 1790630, Shan3xi, 710038
Status
Recruiting
Address
Shanxi Bethune Hospital
Taiyuan 1793511, Shanxi 1795912, 030032
Status
Recruiting
Address
Sichuan Cancer Hospital/Medical Oncology Department
Chengdu 1815286, Sichuan 1794299, 00000
Status
Recruiting
Address
The First Hospital Affiliated To AMU - Southwest Hospital
Chongqing, Sichuan 1794299, 400030
Status
Completed
Address
Local Institution - 6725
Hangzhou 1808926, Zhejiang 1784764, 310016
Status
Recruiting
Address
Zhejiang Cancer Hospital-Oncology
Hangzhou 1808926, Zhejiang 1784764, 310022
Status
Recruiting
Address
The Third Xiangya Hospital of Central South University/Department of Respiratory and Critical Care Medicine
Changsha 1815577, , 00000
Status
Recruiting
Address
West China Hospital Sichuan University/Lung cancer center
Chengdu 1815286, , 00000
Status
Recruiting
Address
The First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou 1808926, , 310003
Status
Recruiting
Address
Anhui Provincial Hospital
Hefei 1808722, , 230001
Status
Recruiting
Address
Shanghai Chest Hospital
Shanghai 1796236, , 200030
Status
Recruiting
Address
Shanghai Chest Hospital
Shanghai 1796236, , 200030
Status
Recruiting
Address
Weifang People's Hospital/Medical Oncology Department
Weifang 1791681, , 00000
Status
Recruiting
Address
Henan Cancer Hospital/The 1st pneumology department
Zhengzhou 1784658, , 00000
Status
Completed
Address
Local Institution - 4901
Copenhagen 2618425, , 2100
Status
Completed
Address
Local Institution - 4201
Marseille 2995469, Bouches-du-Rhône, 13005
Status
Completed
Address
Local Institution - 4207
Brest 3030300, , 29200
Status
Completed
Address
Local Institution - 4204
Dijon 3021372, , 21079
Status
Completed
Address
Local Institution - 4206
Grenoble 3014728, , 38043
Status
Recruiting
Address
Centre Antoine-Lacassagne
Nice 2990440, , 06189
Status
Recruiting
Address
Chu Poitiers
Poitiers 2986495, , 86000
Status
Completed
Address
Local Institution - 4203
Saint-Mandé 2978621, , 94163
Status
Recruiting
Address
Institute Gustave Roussy
Villejuif 2968705, , 98405
Status
Completed
Address
Local Institution - 4704
Berlin 2950159, , 13125
Status
Completed
Address
Local Institution - 4701
Cologne 2886242, , 50937
Status
Completed
Address
Local Institution - 4703
Dresden 2935022, , 01307
Status
Completed
Address
Local Institution - 4702
Heidelberg 2907911, , 69120
Status
Active, not recruiting
Address
Local Institution - 6502
Hong Kong 1819729, , 0
Status
Active, not recruiting
Address
Local Institution - 6501
Hong Kong 1819729, ,
Status
Completed
Address
Local Institution - 5101
Budapest 3054643, , 1083
Status
Completed
Address
Local Institution - 5103
Budapest 3054643, , 1121
Status
Completed
Address
Local Institution - 4301
Milan 6951411, MI, 20133
Status
Completed
Address
Local Institution - 4306
Milan 6951411, , 20122
Status
Withdrawn
Address
Local Institution - 4307
Palermo 2523920, , 90146
Status
Completed
Address
Local Institution - 4303
Pordenone 3170147, , 33081
Status
Not yet recruiting
Address
Local Institution - 4304
Ravenna 3169561, , 48121
Status
Completed
Address
Local Institution - 4305
Reggio Emilia 3169522, , 42123
Status
Completed
Address
Local Institution - 4308
Roma 8957247, , 144
Status
Completed
Address
Local Institution - 4302
Terni 3165771, , 05100
Status
Recruiting
Address
Ehime University Hospital
Tōon 11611474, Ehime 1864226, 791-0295
Status
Recruiting
Address
Hokkaido University Hospital
Sapporo 2128295, Hokkaido 2130037, 0608648
Status
Recruiting
Address
Kanagawa cancer center
Yokohama 1848354, Kanagawa 1860291, 2418515
Status
Recruiting
Address
Osaka City General Hospital
Osaka 1853909, Osaka 1853904, 5340021
Status
Recruiting
Address
National Cancer Center Hospital.
Chuo-ku, Tokyo 1850144, 1040045
Status
Recruiting
Address
Tottori University Hospital
Yonago 1848277, Tottori 1849890, 683-8504
Status
Recruiting
Address
National Cancer Center Hospital East
Kashiwa 1859924, , 277-8577
Status
Recruiting
Address
Nagoya University Hospital
Nagoya 1856057, , 466-8560
Status
Recruiting
Address
Osaka International Cancer institute
Osaka 1853909, , 5418567
Status
Completed
Address
Local Institution - 4502
Amsterdam 2759794, , 1066 CX
Status
Completed
Address
Local Institution - 4501
Groningen 2755251, , 9713 GZ
Status
Recruiting
Address
Ośrodek Badań Klinicznych Wczesnych Faz, Uniwersyteckie Centrum Kliniczne
Gdansk 3099434, , 80-214
Status
Completed
Address
Local Institution - 4604
Lublin 765876, , 20-609
Status
Completed
Address
Local Institution - 4605
Poznan 3088171, , 60-693
Status
Completed
Address
Local Institution - 4603
Szczecin 3083829, , 70-784
Status
Completed
Address
Local Institution - 4602
Warsaw 756135, , 02-781
Status
Completed
Address
Local Institution - 6401
Singapore 1880252, , 119074
Status
Completed
Address
Local Institution - 6402
Singapore 1880252, , 169610
Status
Completed
Address
Local Institution - 3003
Seoul 1835848, Gangnam-gu, 06351
Status
Completed
Address
Local Institution - 6308
Hwasun-eup, Hwasun-gun, Jeollanam-do 1845788, 519-763
Status
Recruiting
Address
Yonsei University Health System
Seoul 1835848, Seodaemun-gu, 03722
Status
Withdrawn
Address
Local Institution - 3002
Seoul 1835848, Seoul Teugbyeolsi, 03080
Status
Completed
Address
Local Institution - 6301
Seoul 1835848, Seoul-teukbyeolsi [Seoul], 03080
Status
Completed
Address
Local Institution - 6303
Seoul 1835848, Seoul-teukbyeolsi [Seoul], 06351
Status
Completed
Address
Local Institution - 6306
Cheongju-si 1845604, , 28644
Status
Recruiting
Address
Seoul National University Hospital
Seoul 1835848, , 03080
Status
Completed
Address
Local Institution - 6302
Seoul 1835848, , 03722
Status
Completed
Address
Local Institution - 6307
Seoul 1835848, , 05030
Status
Completed
Address
Local Institution - 6305
Seoul 1835848, , 05505
Status
Completed
Address
Local Institution - 6304
Seoul 1835848, , 06591
Status
Completed
Address
Local Institution - 4102
Barcelona 3128760, , 08028
Status
Completed
Address
Local Institution - 4101
Barcelona 3128760, , 8035
Status
Completed
Address
Local Institution - 4106
Madrid 3117735, , 28033
Status
Completed
Address
Local Institution - 4104
Madrid 3117735, , 28040
Status
Completed
Address
Local Institution - 4103
Madrid 3117735, , 28041
Status
Completed
Address
Local Institution - 4105
Madrid 3117735, , 28050
Status
Recruiting
Address
Clinica Universidad de Navarra
Pamplona 3114472, , 31008
Status
Recruiting
Address
Instituto Valenciano de Oncología (IVO) - Unidad de Investigación Clínica FINCIVO
Valencia 2509954, , 46009
Status
Active, not recruiting
Address
Local Institution - 6201
Taiepi, , 100
Status
Active, not recruiting
Address
Local Institution - 6203
Tainan City 1668355, , 704
Status
Completed
Address
Local Institution - 6202
Taipei 1668341, , 10449
Status
Completed
Address
Local Institution - 4401
London 2643743, , SW3 6JJ
Status
Completed
Address
Local Institution - 4402
London 2643743, , W12 OHS
Status
Completed
Address
Local Institution - 4404
London 2643743, , W1G 6AD
Status
Completed
Address
Local Institution - 4403
Manchester 2643123, , M20 4BX
Status
Completed
Address
Local Institution - 4405
Sutton 2636503, , SM2 5PT