A New Drug Used for Advanced Cancer

NCT ID: NCT03447145

Last Updated: 2018-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-26
• Study Completion Date: 2018-12-26

Brief Summary

To identify the safety and tolerance of TQ-B3203.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQ-B3203

Group Type: EXPERIMENTAL

TQ-B3203

Intervention Type: DRUG

dose escalation, 2/4/6/10/14/18mg/m2

Interventions

TQ-B3203

dose escalation, 2/4/6/10/14/18mg/m2

Intervention Type: DRUG

Eligibility Criteria

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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

wang zi ping, doctor

Role: CONTACT

wangzp2007@126.com

010-88196456

Facility Contacts

wang zi ping, doctor

Role: primary

wangzp2007@126.com

010-88196456

Other Identifiers

TQ-B3203-I-01

Identifier Type: -

Identifier Source: org_study_id