A Phase I Study of TQ-B3139 on Tolerance and Pharmacokinetics
NCT ID: NCT03099330
Last Updated: 2017-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2017-07-19
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TQ-B3139
TQ-B3139 p.o. qd
TQ-B3139
TQ-B3139 p.o. qd
Interventions
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TQ-B3139
TQ-B3139 p.o. qd
Eligibility Criteria
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Inclusion Criteria
* Lack of the standard treatment or treatment failure
* 18-65years,ECOG PS:0-1,Life expectancy of more than 3 months
* Patients with anti-treatment or surgery within 4 weeks
* Main organs function is normal
* Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
* Patients should participate in the study voluntarily and sign informed consent
Exclusion Criteria
* Blood pressure unable to be controlled(systolic pressure\>140 mmHg，diastolic pressure\>90 mmHg).
Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥470ms)
* Patients with non-healing wounds or fractures
* Patients with drug abuse history and unable to get rid of or Patients with mental disorders
* History of immunodeficiency
* Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
18 Years
65 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Sun-Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Li Zhang, doctor
Role: primary
Su Li
Role: backup
References
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Ma Y, Zhao H, Xue J, Liu L, Yang N, Zhang Y, Yang H, Hong S, Xiong Y, Zhang Z, Zeng L, Pan H, Zhou C, Zhang Y, Wang X, Han X, Wan X, Shao Y, Liu J, Yang Y, Huang Y, Zhao Y, Fang W, Li S, Zhang L. First-in-human phase I study of TQ-B3139 (CT-711) in advanced non-small cell lung cancer patients with ALK and ROS1 rearrangements. Eur J Cancer. 2022 Sep;173:238-249. doi: 10.1016/j.ejca.2022.06.037. Epub 2022 Aug 5.
Other Identifiers
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TQ-B3139-I-0001
Identifier Type: -
Identifier Source: org_study_id