Tolerance and Pharmacokinetics of TQ-B3233

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

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

Study Overview

• Status: Unknown
• Conditions: Tumor
• Intervention / Treatment: Drug: TQ-B3233

Detailed 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）.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100142
    • Recruiting
    • Beijing Cancer Hospital
    • Contact: Jun Guo, doctor; Phone Number: 010-88196317; Email: guoj307@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQ-B3233 capsule; QD or BID; patients are given the doses according to the protocal, and a cycle is 28 days.	Drug: TQ-B3233; QD or BID in different stage of this research

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR)	up to 24 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: December 23, 2017
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: pharmacokinetics; tumor; toleration; TQ-B3233
• Other Study ID Numbers: TQ-B3233-I-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No