A New Drug Used for Advanced Cancer

NCT03447145 | Unknown Phase 1

• 1 other identifier: TQ-B3203-I-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To identify the safety and tolerance of TQ-B3203.

Conditions

Cancer

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Objective Response Rate(ORR)

  each 42 days up to intolerance the toxicity or progression disease (up to 24 months)

Study Arms (1)

TQ-B3203

EXPERIMENTAL

Drug: TQ-B3203

Interventions

TQ-B3203 DRUG

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

TQ-B3203

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 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
• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

wang zi ping, doctor

CONTACT

010-88196456; wangzp2007@126.com

Study Design

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

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: February 27, 2018
• Study Start: December 26, 2017
• Primary Completion: December 26, 2018
• Study Completion: December 26, 2018
• Last Updated: February 27, 2018

Record last verified: 2018-02

Locations

CN (1)