A Phase I Study of TQ-B3234 on Tolerance and Pharmacokinetics
NCT ID: NCT02996838
Last Updated: 2019-05-21
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
2017-05-11
2020-12-31
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-B3234
TQ-B3234 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
TQ-B3234
TQ-B3234 p.o. qd
Interventions
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TQ-B3234
TQ-B3234 p.o. qd
Eligibility Criteria
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Inclusion Criteria
* Lack of the standard treatment or treatment failure
* 18-65 years,ECOG PS:0-1,Life expectancy of more than 3 months
* Main organs function is normal
* Stop other previous chemotherapy drugs more than 4 weeks
* 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 QTc≥440ms)
* 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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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Zhao Yan, pharmacist
Role: CONTACT
Facility Contacts
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Xiubao Ren, doctor
Role: primary
Zhao Yan, pharmacist
Role: backup
Other Identifiers
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TQ-B3234-I-0001
Identifier Type: -
Identifier Source: org_study_id
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