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Status unknownNCT03447145Updated Feb 27, 2018

A New Drug Used for Advanced Cancer

A Phase 1 interventional study of TQ-B3203 in Cancer, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-02-27.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

To identify the safety and tolerance of TQ-B3203.

02

Conditions studied

  • Cancer
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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);
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    TQ-B3203

    Drug: TQ-B3203

Interventions

  • DrugTQ-B3203

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

05

What researchers measure

Primary outcomes

  1. The maximum tolerated dose(MTD)

    Time frame: 21 days

  2. dose-limiting toxicity(DLT)

    Time frame: 21 days

  3. Peak Plasma Concentration(Cmax)

    Time frame: 21 days

  4. Peak time(Tmax)

    Time frame: 21 days

  5. Half life(t1/2)

    Time frame: 21 days

  6. Area under the plasma concentration versus time curve (AUC)

    Time frame: 21 days

  7. Clearance(CL)

    Time frame: 21 days

Secondary outcomes

  1. Objective Response Rate(ORR)

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

06

Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, Beijing 100021, China
    Recruiting
07

Registry details

Key details

Study ID
NCT03447145
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Feb 27, 2018
Start date
Dec 26, 2017
Primary completion
Dec 26, 2018 (estimated)
Completion
Dec 26, 2018 (estimated)
Last update
Feb 27, 2018

Study contacts

wang zi ping, doctor
Contact
wangzp2007@126.com
010-88196456

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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