Overview

A Phase I Study of TQ-B3139 on Tolerance and Pharmacokinetics

Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
All
Summary
A study of TQ-B3139, inhibitor of ALK/C-Met tyrosine kinase, in patient with advanced cancer
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
Criteria
Inclusion Criteria:

- Histological documentation of Advanced solid tumors

- 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:

- Patients participated in other anticancer drug clinical trials within 4 weeks

- 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