A New Drug Used for Advanced Cancer

Phase I Study of Tolerance and Pharmacokinetics of TQ-B3203

To identify the safety and tolerance of TQ-B3203.

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Drug: TQ-B3203

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

Contacts and Locations

• Study Contact: Name: wang zi ping, doctor; Phone Number: 010-88196456; Email: wangzp2007@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: wang zi ping, doctor; Phone Number: 010-88196456; Email: wangzp2007@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 definitedly diagnosed by pathology and/or cytology as advanced solid tumor,those who lack of standard treatments or treatment failure;
• Patients treated with chemotherapy agents or surgery before being enrolled into the study need waiting for 30 days, 6 weeks will be needed if agents were Nitrocarbamide and Mitomycin C
• 18-70 years old,Eastern Cooperative Oncology Group(ECOG):0-1,Life expectancy of more than 3 months,BMI:18.5-26;
• 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 consents 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 participated in other anticancer drug clinical trials within 4 weeks;
• Patients treated with Irinotecan,Topotecan and any other topoisomerase I inhibitors or related clinical trials;
• Patients of double locus mutation of UGT1A1*6、UGT1A1*28;
• Patients who cannot stop using inhibitors of CYP3A4 and UGT1A1 7 days before enrolled in the study,inducers of CYP3A4 need 2 weeks.
• Patients who can not be injected and patients with interstitial pneumonia or radiation pneumonia;
• Patients with pericardial effusion,pleural effusion or ascitic fluid, patients with 2nd respiratory syndrome or above are refused according to National Cancer Institute Common Terminology Criteria for Adverse Events(CTC AE);
• 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;
• Patients with non-healing wounds or fractures;
• Patients got radiotherapy for bone metastases 2 weeks before being enrolled in the study;
• Patients with urine pro 2+ and the quantitative result>1.0g
• Patients got Arteriovenous thrombosis 6 months before being the study "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 immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;
• Patients with thyroid dysfunction;
• Patients diagnosed with glaucoma,or prostatomegaly need to be treated;
• Coagulation function abnormality: haemorrhagic tendencies (e.g. active digestive tract ulcer), or are receiving thrombolytic or anticoagulant therapy
• Patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators;
• Patient with hepatitis b surface antigen positive(HBV DNA>1000) or hepatitis C virus(HCV);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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-B3203	Drug: TQ-B3203; dose escalation, 2/4/6/10/14/18mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The maximum tolerated dose(MTD)	21 days
dose-limiting toxicity(DLT)	21 days
Peak Plasma Concentration(Cmax)	21 days
Peak time（Tmax）	21 days
Half life（t1/2）	21 days
Area under the plasma concentration versus time curve (AUC)	21 days
Clearance（CL）	21 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate(ORR)	each 42 days up to intolerance the toxicity or progression disease (up to 24 months)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2017
• Primary Completion (Anticipated): December 26, 2018
• Study Completion (Anticipated): December 26, 2018

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: February 25, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 25, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: TQ-B3203-I-01

Drug and device information, study documents

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