Trial Title:
A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
NCT ID:
NCT03093116
Condition:
Locally Advanced Solid Tumors
Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
ALK
ROS1
NTRK
Sarcoma
Lung Neoplasms
Carcinoma, NSCL
NSCLC
Non Small Cell Lung
Thyroid Disease
Colonic Neoplasms
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Disease
Respiratory Tract Disease
Carcinoma, Bronchogenic
Bronchial Neoplasms
Endocrine System Disease
Colorectol Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Disease
Colonic Disease
Intestinal Disease
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Non Small Cell Lung Cancer
Solid Tumors
Rearrangements
TRIDENT-1
TKI
TKI naive
TKI pretreated
Anti-tumor activity
Repotrectinib
Advanced Solid Malignancies
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Oral repotrectinib (TPX-0005)
Description:
Oral repotrectinib (TPX-0005) capsules.
Arm group label:
Repotrectinib (TPX-0005)
Other name:
repotrectinib
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.
Criteria for eligibility:
Criteria:
PHASE 1
Key Inclusion Criteria:
1. Histologically or cytologically confirmed diagnosis of locally advanced, or
metastatic solid tumor (including primary CNS tumors) (Stage IV, American Joint
Committee on Cancer v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene
rearrangement by protocol specified tests.
2. ECOG PS 0-1.
3. Age ≥18 (or age ≥ 20 of age as required by local regulation).
4. Capability to swallow capsules intact (without chewing, crushing, or opening).
5. At least 1 measurable target lesion according to RECIST version 1.1. CNS-only
measurable disease as defined by RECIST version 1.1 is allowed.
6. Prior cytotoxic chemotherapy is allowed.
7. Prior immunotherapy is allowed.
8. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer
therapy to National Cancer Institute Common Terminology Criteria for Adverse Events
(NCI CTCAE) Version 4.03 Grade less than or equal to 1.
9. Patients with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic
leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol
specified criteria.
10. Baseline laboratory values fulfilling the following requirements:Absolute
neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100
× 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or
creatinine clearance Within normal limits or > 40 mL/min; Total serum bilirubin <
1.5 × ULN; Liver transaminases (ASTs/ALTs) < 2.5 × ULN; < 5 × ULN if liver
metastases are present Alkaline phosphatase (ALP); < 2.5 × ULN; < 5 × ULN if liver
and/or bone metastasis are present; Serum calcium, magnesium, and potassium Normal
or CTCAE grade ≤ 1 with or without supplementation
11. Life expectancy ≥ 3 months.
PHASE 2 Key Inclusion Criteria
1. Histologically or cytologically confirmed diagnosis of locally advanced, or
metastatic solid tumor (including primary CNS tumors) that harbors a ROS1, or
NTRK1-3 gene fusion.
2. Subject must have a documented ROS1 or NTRK1-3 gene fusion determined by
tissue-based local testing using either:
1. a next-generation sequencing (NGS) or quantitative polymerase chain reaction
(qPCR) test will be accepted to determine molecular eligibility.
• Adequate tumor tissue needs to be sent to the Sponsor designated central
diagnostic laboratory for retrospective confirmation by a central diagnostic
laboratory test selected by the Sponsor.
OR
2. a fluorescence in situ hybridization (FISH) test AND prospective confirmation
of fusion status by a central diagnostic laboratory test selected by the
Sponsor PRIOR to enrollment will be accepted to determine molecular
eligibility.
- Adequate tumor tissue must be sent to the Sponsor designated central
diagnostic laboratory for prospective confirmation by a central diagnostic
laboratory test selected by the Sponsor PRIOR to enrollment.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
4. Age ≥12 (or age ≥ 20 as required by local regulation).
5. Willing and able to provide written institutional review board (IRB)/institutional
ethics committee-approved Informed Consent or an Assent signed by a parent or legal
guardian for subjects age 12 to 17.
6. At least 1 measurable target lesion according to RECIST (v1.1) prospectively
confirmed by Blinded Independent Central Radiology Review (BICR), selected by
Sponsor, PRIOR to enrollment. Subjects with CNS-only measurable disease ≥10 mm as
defined by RECIST (v1.1) are eligible.
7. Subjects with advanced solid tumors harboring ROS1, NTRK1, NTRK2, or NTRK3
rearrangement will be assigned into 6 distinct expansion (EXP) cohorts provided all
inclusion and exclusion criteria are met.
i. EXP-1: ROS1 TKI-naïve ROS1+ NSCLC ii. EXP-2: 1 Prior ROS1 TKI and 1 Platinum
based chemo ROS1+ NSCLC iii. EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO)
iv. EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO) v. EXP-5: TRK TKI-naïve
NTRK+ solid tumors vi. EXP-6: TRK TKI-pretreated NTRK+ solid tumors
8. Subjects with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic
leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol
specified criteria.
9. Baseline laboratory values fulfilling the following requirements:Absolute
neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100
× 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or
creatinine clearance > 40 mL/min; Total serum bilirubin < 1.5 × ULN; Liver
transaminases (ASTs/ALTs) < 2.5 × ULN; < 5 × ULN if liver metastases are present
Alkaline phosphatase (ALP); < 2.5 × ULN; < 5 × ULN if liver and/or bone metastasis
are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with
or without supplementation
10. Life expectancy ≥ 3 months.
Key Exclusion Criteria PHASE 1 and PHASE 2
1. Concurrent participation in another therapeutic clinical trial.
2. Symptomatic brain metastases or leptomeningeal involvement.
3. History of previous cancer, except for squamous cell or basal-cell carcinoma of the
skin, or any in situ carcinoma that has been completely resected, requiring therapy
within the previous 2 years.
4. Major surgery within 4 weeks of start of repotrectinib treatment. Radiation therapy
(except palliative to relieve bone pain) within 2 weeks of study entry. Palliative
radiation (≤10 fractions) must have been completed at least 48 hours prior to study
entry
5. Clinically significant cardiovascular disease (either active or within 6 months
prior to enrollment): myocardial infarction, unstable angina, coronary/peripheral
artery bypass graft, symptomatic congestive heart failure (New York Heart
Association Classification Class ≥ II), cerebrovascular accident or transient
ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic
medication. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2
6. Any of the following cardiac criteria:
Mean resting corrected QT interval (ECG interval measured from the onset of the QRS
complex to the end of the T wave) for heart rate (QTcF) > 470 msec obtained from 3
ECGs, using the screening clinic ECG machine-derived QTc value Any clinically
important abnormalities in rhythm, conduction or morphology of resting ECG (e.g.,
complete left bundle branch block, third degree heart block, second degree heart
block, PR interval > 250 msec) Any factors that increase the risk of QTc
prolongation or risk of arrhythmic events such as heart failure, hypokalemia,
congenital long QT syndrome, family history of long QT syndrome, or any concomitant
medication known to prolong the QT interval.
7. Known active infections (bacterial, fungal, viral including HIV positivity).
8. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut
syndrome) or other malabsorption syndromes that would impact drug absorption.
9. Peripheral neuropathy of CTCAE ≥grade 2.
10. History of extensive, disseminated, bilateral, or presence of CTCAE grade 3 or 4
interstitial fibrosis or interstitial lung disease including a history of
pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung
disease, obliterative bronchiolitis, and pulmonary fibrosis. Subjects with history
of prior radiation pneumonitis are not excluded.
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City Of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nishan Tchekmedyian, Site 2129
Phone:
562-590-0345
Facility:
Name:
Adventist Health Glendale
Address:
City:
Glendale
Zip:
91206
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mihran Shirinian, Site 2120
Phone:
818-409-6687
Facility:
Name:
UC San Diego Health
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lyudmila Bazhenova, Site 2114
Phone:
866-773-2703
Facility:
Name:
Pacific Shores Medical Group
Address:
City:
Long Beach
Zip:
90813
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nishan Tchekmedyian, Site 2121
Phone:
562-590-0345
Facility:
Name:
UC Irvine Medical Center
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Misako Nagasaka, Site 2101
Phone:
714-456-5153
Facility:
Name:
St Joseph Heritage Healthcare
Address:
City:
Santa Rosa
Zip:
95403
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ian Anderson, Site 2126
Facility:
Name:
University Of Colorado Denver
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ross Camidge, Site 2103
Phone:
720-848-0449
Facility:
Name:
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stephen Liu, Site 2106
Phone:
202-444-2223
Facility:
Name:
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Address:
City:
Washington
Zip:
20016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Benjamin Levy, Site 2110
Phone:
347-324-6573
Facility:
Name:
Memorial Healthcare System
Address:
City:
Hollywood
Zip:
33021
Country:
United States
Status:
Recruiting
Contact:
Last name:
Luis Raez, Site 2128
Phone:
954-265-4325
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Benjamin Creelan, Site 2113
Phone:
813-745-6895
Facility:
Name:
University Cancer and Blood Center
Address:
City:
Athens
Zip:
30607
Country:
United States
Status:
Recruiting
Contact:
Last name:
PETROS NIKOLINAKOS, Site 2139
Phone:
706-353-2990
Facility:
Name:
Colombus Regional Research Institute
Address:
City:
Columbus
Zip:
31904
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrew Pippas, Site 2134
Phone:
706-660-6449
Facility:
Name:
University of Chicago
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christine Bestvina, Site 2125
Phone:
773-702-4400
Facility:
Name:
Illinois Cancer Care
Address:
City:
Peoria
Zip:
61615
Country:
United States
Status:
Recruiting
Contact:
Last name:
Greg Gerstner, Site 2142
Facility:
Name:
University of Maryland Medical Center
Address:
City:
Baltimore
Zip:
21210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katherine Scilla, Site 2133
Phone:
410-328-6373
Facility:
Name:
Massachusetts General Hospital,
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Lin, Site 2104
Phone:
617-724-4000
Facility:
Name:
Dana Farber Cancer Institute.
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mark Awad, Site 2131
Phone:
617-632-3468
Facility:
Name:
University Of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Angel Qin, Site 2105
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dipesh Uprety, Site 2111
Phone:
215-285-2261
Facility:
Name:
Henry Ford Transplant Institute
Address:
City:
Detroit
Zip:
48202-2608
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shirish Gadgeel, Site 2140
Phone:
313-399-0508
Facility:
Name:
Regions Hospital - Cancer Care Center
Address:
City:
Saint Paul
Zip:
55101
Country:
United States
Status:
Recruiting
Contact:
Last name:
Arkadiusz Dudek, Site 2132
Phone:
31299615816512543321
Facility:
Name:
Central Care Cancer Center
Address:
City:
Bolivar
Zip:
65613
Country:
United States
Status:
Recruiting
Contact:
Last name:
Leonid Shunyakov, Site 2147
Phone:
417-326-7200
Facility:
Name:
Washington University Infusion Center Pharmacy
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Van Tine, Site 2115
Phone:
314-747-3096
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Contact:
Last name:
Scott Moerdler, Site 2122
Phone:
000-000-0000
Facility:
Name:
Laura & Isaac Perlmutter Cancer Center
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vamsidhar Velcheti, Site 2117
Phone:
216-903-4153
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexander Drilon, Site 2102
Phone:
646-888-4206
Facility:
Name:
Southeastern Medical Oncology Center
Address:
City:
Goldsboro
Zip:
27534
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samer Kasbari, Site 2144
Phone:
919-580-0000
Facility:
Name:
Gabrail Cancer Center
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nashat Gabrail, Site 2112
Phone:
330-417-8231
Facility:
Name:
Trihealth Cancer Institute
Address:
City:
Cincinnati
Zip:
45220
Country:
United States
Status:
Recruiting
Contact:
Last name:
Faisal Adhami, MD, Site 2143
Facility:
Name:
Cleveland Clinic Main Campus
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pete Anderson, Site 2109
Facility:
Name:
The Ohio State University Wexner Medical Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dwight Owen, Site 2123
Phone:
614-293-6401
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111-2497
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Bauman, Site 2108
Phone:
215-728-5673
Facility:
Name:
Baptist Memorial Hospital Baptist Cancer Center
Address:
City:
Memphis
Zip:
38120
Country:
United States
Status:
Recruiting
Contact:
Last name:
Philip Lammers, Site 2148
Facility:
Name:
UT Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Syed Kazmi, Site 2130
Phone:
214-648-5368
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yasir Elamin, Site 2138
Facility:
Name:
Oncology Consultants, P.A.
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julio Peguero, Site 2127
Phone:
713-600-0913
Facility:
Name:
Lumi Research
Address:
City:
Kingwood
Zip:
77339
Country:
United States
Status:
Recruiting
Contact:
Last name:
Saleha Sajid, Site 2146
Phone:
832-553-3661
Facility:
Name:
Virginia Cancer Specialists, PC
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexander Spira, Site 2137
Phone:
703-280-5390
Facility:
Name:
University of Washington-Seattle Cancer Care Alliance
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christina Baik, Site 2107
Facility:
Name:
ThedaCare
Address:
City:
Appleton
Zip:
54911
Country:
United States
Status:
Recruiting
Contact:
Last name:
Matthias Weiss, Site 2145
Facility:
Name:
Local Institution - 6102
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Site 6102
Facility:
Name:
Local Institution - 6103
Address:
City:
Adelaide
Zip:
5042
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Site 6103
Facility:
Name:
Local Institution - 6101
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Site 6101
Facility:
Name:
Local Institution - 4802
Address:
City:
Antwerp
Zip:
2650
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Site 4802
Facility:
Name:
Local Institution - 4801
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Site 4801
Facility:
Name:
Local Institution - 2202
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Site 2202
Facility:
Name:
Local Institution - 2205
Address:
City:
Vancouver
Zip:
V5Z 4E7
Country:
Canada
Status:
Withdrawn
Facility:
Name:
Local Institution - 2201
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Site 2201
Facility:
Name:
Local Institution - 6503
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Site 6503
Facility:
Name:
Local Institution - 2203
Address:
City:
Ontario
Zip:
L6R 37R
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Site 2203
Facility:
Name:
Local Institution - 2204
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Site 2204
Facility:
Name:
Local Institution - 6702
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Completed
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Fang, Site 6703
Phone:
868613701224460
Facility:
Name:
Daping Hospital, the Third Affiliated Hospital of Third Military Medical University /Cancer Center
Address:
City:
Daping
Zip:
00000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yong He, Site 6736
Phone:
13908338998
Facility:
Name:
Local Institution - 6719
Address:
City:
Fuzhou
Zip:
000000
Country:
China
Status:
Completed
Facility:
Name:
The First Affiliated hospital of Xiamen University-oncology
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingxun Wu, Site 6708
Facility:
Name:
Guangdong Provincial People'S Hospital
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinji Yang, Site 6747
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical University-Pneumology department
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Huaqiu Shi, Site 6733
Facility:
Name:
Local Institution - 6505
Address:
City:
Shenzhen
Zip:
518053
Country:
China
Status:
Recruiting
Contact:
Last name:
Site 6505
Facility:
Name:
The Affiliated Tumor Hospital of Harbin Medical University
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Yu, Site 6722
Phone:
13904505825
Facility:
Name:
Local Institution - 6504
Address:
City:
Shatin
Zip:
999077
Country:
China
Status:
Recruiting
Contact:
Last name:
Site 6504
Facility:
Name:
Local Institution - 6705
Address:
City:
Changsha
Zip:
410011
Country:
China
Status:
Completed
Facility:
Name:
Hunan Cancer Hospital-thoracic oncology II
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Nong Yang, Site 6718
Phone:
13055193557
Facility:
Name:
Nanjing Drum Tower hospital
Address:
City:
Nanjing
Zip:
210008
Country:
China
Status:
Recruiting
Contact:
Last name:
Liyun Miao, Site 6748
Facility:
Name:
XuZhou Central Hospital/Oncology Department
Address:
City:
Xuzhou City
Zip:
00000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiang Wang, Site 6732
Facility:
Name:
Local Institution - 6714
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Contact:
Last name:
Site 6714
Facility:
Name:
Local Institution - 6742
Address:
City:
Shenyang
Zip:
110801
Country:
China
Status:
Recruiting
Contact:
Last name:
Site 6742
Facility:
Name:
Tangdu Hospital
Address:
City:
Xi'an
Zip:
710038
Country:
China
Status:
Recruiting
Contact:
Last name:
Haichuan Su, Site 6754
Facility:
Name:
Shanxi Bethune Hospital
Address:
City:
Taiyuan
Zip:
030032
Country:
China
Status:
Recruiting
Contact:
Last name:
Junping Zhang, Site 6749
Phone:
13994204099
Facility:
Name:
Sichuan Cancer Hospital/Medical Oncology Department
Address:
City:
Chengdu City
Zip:
00000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenxiu Yao, Site 6728
Phone:
18908178836
Facility:
Name:
Local Institution - 6716
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Site 6716
Facility:
Name:
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Status:
Recruiting
Contact:
Last name:
Kejing Ying, Site 6725
Phone:
8613588706900
Facility:
Name:
Zhejiang Cancer Hospital-Oncology
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Yiping Zhang, Site 6721
Facility:
Name:
Jilin Cancer Hospital/Medical Oncology Department
Address:
City:
Changchun City
Zip:
000000
Country:
China
Status:
Recruiting
Contact:
Last name:
Meili Sun, Site 6720
Phone:
18953116532
Facility:
Name:
Jilin Cancer Hospital/Medical Oncology Department
Address:
City:
Changchun City
Zip:
000000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Cheng, Site 6717
Phone:
8613943012851
Facility:
Name:
The Third Xiangya Hospital of Central South University/Department of Respiratory and Critical Care Medicine
Address:
City:
Changsha
Zip:
00000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Meng, Site 6734
Facility:
Name:
West China Hospital Sichuan University/Lung cancer center
Address:
City:
Chengdu
Zip:
00000
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Luo, Site 6724
Phone:
+8618980601766
Facility:
Name:
The First Affiliated Hospital - Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianying Zhou, Site 6712
Phone:
8613505719970
Facility:
Name:
Local Institution - 6704
Address:
City:
Hefei
Zip:
230001
Country:
China
Status:
Recruiting
Contact:
Last name:
Site 6704
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Liyan Jiang, Site 6709
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Shun Lu, Site 6701
Phone:
8613601813062
Facility:
Name:
Weifang People's Hospital/Medical Oncology Department
Address:
City:
Weifang City
Zip:
00000
Country:
China
Status:
Recruiting
Contact:
Last name:
Guohua Yu, Site 6727
Facility:
Name:
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology/Cancer Center Department
Address:
City:
Wuhan
Zip:
000000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaorong Dong, Site 6710
Phone:
13986252286
Facility:
Name:
Henan Cancer Hospital/The 1st pneumology department
Address:
City:
Zhengzhou
Zip:
00000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiufeng Hu, Site 6715
Phone:
+8618339920984
Facility:
Name:
Local Institution - 4901
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Site 4901
Facility:
Name:
Local Institution - 4201
Address:
City:
Marseille
Zip:
13005
Country:
France
Status:
Recruiting
Contact:
Last name:
Site 4201
Facility:
Name:
Local Institution - 4207
Address:
City:
Brest
Zip:
29200
Country:
France
Status:
Recruiting
Contact:
Last name:
Site 4207
Facility:
Name:
Local Institution - 4204
Address:
City:
Dijon Cedex
Zip:
21079
Country:
France
Status:
Recruiting
Contact:
Last name:
Site 4204
Facility:
Name:
Local Institution - 4206
Address:
City:
Grenoble Cedex 9
Zip:
38043
Country:
France
Status:
Recruiting
Contact:
Last name:
Site 4206
Facility:
Name:
Local Institution - 4205
Address:
City:
Nice
Zip:
06189
Country:
France
Status:
Recruiting
Contact:
Last name:
Site 4205
Facility:
Name:
Local Institution - 4208
Address:
City:
Poitiers
Zip:
86000
Country:
France
Status:
Recruiting
Contact:
Last name:
Site 4208
Facility:
Name:
Local Institution - 4203
Address:
City:
St Mande
Zip:
94163
Country:
France
Status:
Recruiting
Contact:
Last name:
Site 4203
Facility:
Name:
Local Institution - 4202
Address:
City:
Villejuif
Zip:
98405
Country:
France
Status:
Recruiting
Contact:
Last name:
Site 4202
Facility:
Name:
Local Institution - 4704
Address:
City:
Berlin
Zip:
13125
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Site 4704
Facility:
Name:
Local Institution - 4703
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Site 4703
Facility:
Name:
Local Institution - 4702
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Site 4702
Facility:
Name:
Local Institution - 4701
Address:
City:
Koln
Zip:
50937
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Site 4701
Facility:
Name:
Local Institution - 6502
Address:
City:
Hong Kong
Zip:
0
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Site 6502
Facility:
Name:
Local Institution - 6501
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Site 6501
Facility:
Name:
Local Institution - 5101
Address:
City:
Budapest
Zip:
1083
Country:
Hungary
Status:
Recruiting
Contact:
Last name:
Site 5101
Facility:
Name:
Local Institution - 5103
Address:
City:
Budapest
Zip:
1121
Country:
Hungary
Status:
Recruiting
Contact:
Last name:
Site 5103
Facility:
Name:
Local Institution - 4301
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Site 4301
Facility:
Name:
Local Institution - 4306
Address:
City:
Milano
Zip:
20122
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Site 4306
Facility:
Name:
Local Institution - 4307
Address:
City:
Palermo
Zip:
90146
Country:
Italy
Status:
Withdrawn
Facility:
Name:
Local Institution - 4303
Address:
City:
Pordenone
Zip:
33081
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Site 4303
Facility:
Name:
Local Institution - 4305
Address:
City:
Reggio Emilia
Zip:
42123
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Site 4305
Facility:
Name:
Local Institution - 4308
Address:
City:
Roma
Zip:
144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Site 4308
Facility:
Name:
Local Institution - 4302
Address:
City:
Terni
Zip:
05100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Site 4302
Facility:
Name:
Local Institution - 6609
Address:
City:
Toon
Zip:
791-0295
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Site 6609
Facility:
Name:
Local Institution - 6607
Address:
City:
Sapporo-shi
Zip:
0608648
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Site 6607
Facility:
Name:
Local Institution - 6603
Address:
City:
Yokohama
Zip:
2418515
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Site 6603
Facility:
Name:
Local Institution - 6605
Address:
City:
Osaka-shi
Zip:
5340021
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Site 6605
Facility:
Name:
Local Institution - 6604
Address:
City:
Chuo-ku
Zip:
1040045
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Site 6604
Facility:
Name:
Local Institution - 6606
Address:
City:
Yonago
Zip:
683-8504
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Site 6606
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Koichi Goto, Site 6601
Phone:
81471331111
Facility:
Name:
Local Institution - 6608
Address:
City:
Nagoya-shi
Zip:
466-8560
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Site 6608
Facility:
Name:
Local Institution - 6602
Address:
City:
Osaka
Zip:
5418567
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Site 6602
Facility:
Name:
Local Institution - 6308
Address:
City:
Hwasun-eup, Hwasun-gun
Zip:
519-763
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Site 6308
Facility:
Name:
Local Institution - 6301
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Site 6301
Facility:
Name:
Local Institution - 6303
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Site 6303
Facility:
Name:
Local Institution - 6306
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Site 6306
Facility:
Name:
Local Institution - 6302
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Site 6302
Facility:
Name:
Local Institution - 6307
Address:
City:
Seoul
Zip:
05030
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Site 6307
Facility:
Name:
Local Institution - 6305
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Site 6305
Facility:
Name:
Local Institution - 6304
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Site 6304
Facility:
Name:
Local Institution - 4502
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Site 4502
Facility:
Name:
Local Institution - 4501
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Site 4501
Facility:
Name:
Local Institution - 4601
Address:
City:
Gdańsk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Site 4601
Facility:
Name:
Local Institution - 4604
Address:
City:
Lublin
Zip:
20-609
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Site 4604
Facility:
Name:
Local Institution - 4605
Address:
City:
Poznań
Zip:
60-693
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Site 4605
Facility:
Name:
Local Institution - 4603
Address:
City:
Szczecin
Zip:
70-784
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Site 4603
Facility:
Name:
Local Institution - 4602
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Site 4602
Facility:
Name:
Local Institution - 6401
Address:
City:
Singapore
Zip:
119074
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Site 6401
Facility:
Name:
Local Institution - 6402
Address:
City:
Singapore
Zip:
169610
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Site 6402
Facility:
Name:
Local Institution - 4102
Address:
City:
Barcelona
Zip:
08028
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site 4102
Facility:
Name:
Local Institution - 4101
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site 4101
Facility:
Name:
Local Institution - 4106
Address:
City:
Madrid
Zip:
28033
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site 4106
Facility:
Name:
Local Institution - 4104
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site 4104
Facility:
Name:
Local Institution - 4103
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site 4103
Facility:
Name:
Local Institution - 4105
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site 4105
Facility:
Name:
Local Institution - 4108
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site 4108
Facility:
Name:
Local Institution - 4107
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site 4107
Facility:
Name:
Local Institution - 6201
Address:
City:
Taiepi
Zip:
100
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Site 6201
Facility:
Name:
Local Institution - 6203
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Site 6203
Facility:
Name:
Local Institution - 6202
Address:
City:
Taipei
Zip:
10449
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Site 6202
Facility:
Name:
Local Institution - 4401
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Site 4401
Facility:
Name:
Local Institution - 4402
Address:
City:
London
Zip:
W12 OHS
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Site 4402
Facility:
Name:
Local Institution - 4404
Address:
City:
London
Zip:
W1G 6AD
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Site 4404
Facility:
Name:
Local Institution - 4403
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Site 4403
Facility:
Name:
Local Institution - 4405
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Site 4405
Start date:
March 7, 2017
Completion date:
February 29, 2028
Lead sponsor:
Agency:
Turning Point Therapeutics, Inc.
Agency class:
Industry
Collaborator:
Agency:
Zai Lab (Shanghai) Co., Ltd.
Agency class:
Industry
Source:
Turning Point Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT03093116
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
http://www.BMSStudyConnect.com
