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

CTTQ

Status and phase

Unknown

Phase 1

Conditions

Advanced Cancer

Treatments

Drug: TQ-B3139

Study type

Interventional

Funder types

Industry

Identifiers

TQ-B3139-I-0001

Details and patient eligibility

About

A study of TQ-B3139, inhibitor of ALK/C-Met tyrosine kinase, in patient with advanced cancer

Full description

phase I of safety, pharmacokinetic and pharmacodynamic study of TQ-B3139. To recommend a reasonable dose and indication for subsequent research.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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