Tolerance and Pharmacokinetics of TQ-B3233

NCT03453034 | Unknown Phase 1

• 1 other identifier: TQ-B3233-I-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tumor

Keywords

TQ-B3233; tumor; toleration; pharmacokinetics

Outcome Measures

Primary Outcomes (6)

• maximum tolerated dose(MTD)

  28 Days

• dose-limiting toxicity(DLT)

  28 Days

• Peak Plasma Concentration(Cmax)

  up to 28 Days

• Peak time(Tmax)

  up to 28 Days

• Half life(t1/2)

  up to 28 Days

• Area under the plasma concentration versus time curve (AUC)

  up to 28 Days

Secondary Outcomes (1)

• Objective Response Rate (ORR)

  up to 24 months

Study Arms (1)

TQ-B3233 capsule

EXPERIMENTAL

QD or BID; patients are given the doses according to the protocal, and a cycle is 28 days.

Drug: TQ-B3233

Interventions

TQ-B3233 DRUG

QD or BID in different stage of this research

TQ-B3233 capsule

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients definitely diagnosed by pathology and/or cytology as BRAF mutation advanced malignant melanoma.
• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Beijing cancer hospital

Beijing, 100142, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Guo Jun, doctor

CONTACT

010-88196317; guoj307@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2017
• First Posted: March 5, 2018
• Study Start: November 22, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)