Tolerance and Pharmacokinetics of TQ-B3233

Tumor Clinical Trial

Official title:

To Study the Pharmacokinetic Characteristics of TQ-B233 in the Human Body, Recommend a Reasonable Regimen for Subsequent Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03453034
• Other study ID #: TQ-B3233-I-01
• Status: Recruiting
• Phase: Phase 1
• First received: December 23, 2017
• Last updated: February 26, 2018
• Start date: November 22, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2018
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: Guo Jun, doctor
• Phone: 010-88196317
• Email: guoj307[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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）.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Tumor

Intervention

Drug:
• TQ-B3233
QD or BID in different stage of this research

Locations

Country	Name	City	State
China	Beijing cancer hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum tolerated dose(MTD)		28 Days
Primary	dose-limiting toxicity(DLT)		28 Days
Primary	Peak Plasma Concentration(Cmax)		up to 28 Days
Primary	Peak time(Tmax)		up to 28 Days
Primary	Half life(t1/2)		up to 28 Days
Primary	Area under the plasma concentration versus time curve (AUC)		up to 28 Days
Secondary	Objective Response Rate (ORR)		up to 24 months