Tolerance and Pharmacokinetics of TQ-B3233

CTTQ

Status and phase

Unknown

Phase 1

Conditions

Tumor

Treatments

Drug: TQ-B3233

Study type

Interventional

Funder types

Industry

Identifiers

NCT03453034

TQ-B3233-I-01

Details and patient eligibility

About

Study of Tolerance and Pharmacokinetics of TQ-B3233 Capsule, phase I,single arm.

Full description

The maximum tolerated dose (MTD) of TQ-B3233 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment.

Pharmacokinetics of TQ-B3233 (in whole blood):In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H5/H8/H10/H12/H24/H48/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D2/D8/D15/D22/D28（D means Day）.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients definitely diagnosed by pathology and/or cytology as BRAF mutation advanced malignant melanoma.
18-70 years old, ECOG PS:0-1,Life expectancy of more than 3 months;
Patients treated with chemotherapy agents or surgery before being enrolled into the study need waiting for 4 weeks, 6 weeks will be needed if agents were nitrocarbamide and mitomycin C;
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 be voluntary and sign the informed consent before taking part in the study;

Exclusion criteria

Patients with Malignant tumors within 5 years, except for non-melanoma skin cancer and in situ cancer;
Patients who had previously received specific BRAF inhibitors;
A variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.)
Patients who participated in other anticancer drug clinical trials within 4 weeks ;
Blood pressure unable to be controlled ideally by one drug(systolic pressure≥150 mmHg，diastolic pressure≥90 mmHg);
Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias or cardiac insufficiency (including QTc≥480ms) and patients with Grade 3 or higher congestive heart failure (NYHA Classification);
Patients with non-healing wounds or fractures;
Patients with brain metastasis, spinal cord compression, cancerous meningitis, CT or MRI examination reminds patients with cerebral or soft meningeal diseases in the screening phase;
Patients with drug abuse history or unable to get rid of drugs or Patients with mental disorders;
Coagulation function abnormality: haemorrhagic tendencies (e.g. active digestive tract ulcer), or are receiving thrombolytic or anticoagulant therapy;
Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;
Patients with thyroid dysfunction;
Patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators;
Parents with hepatitis b surface antigen positive or HCV;