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Status unknownNCT03453034Updated Mar 5, 2018

Tolerance and Pharmacokinetics of TQ-B3233

A Phase 1 interventional study of TQ-B3233 in Tumor, 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 2018-03-05.

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

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has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.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

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

Read the 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).

02

Conditions studied

  • Tumor

Keywords

  • TQ-B3233
  • tumor
  • toleration
  • pharmacokinetics
03

Who can participate

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

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

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;
04

Study design

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

Study arms

  • 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

Interventions

  • DrugTQ-B3233

    QD or BID in different stage of this research

05

What researchers measure

Primary outcomes

  1. maximum tolerated dose(MTD)

    Time frame: 28 Days

  2. dose-limiting toxicity(DLT)

    Time frame: 28 Days

  3. Peak Plasma Concentration(Cmax)

    Time frame: up to 28 Days

  4. Peak time(Tmax)

    Time frame: up to 28 Days

  5. Half life(t1/2)

    Time frame: up to 28 Days

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

    Time frame: up to 28 Days

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: up to 24 months

06

Study locations

1 of 1 sites recruiting
  • Beijing cancer hospital
    Beijing, 100142, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03453034
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Mar 5, 2018
Start date
Nov 22, 2017
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Mar 5, 2018

Study contacts

Guo Jun, doctor
Contact
guoj307@126.com
010-88196317

Oversight

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

Not currently enrolling

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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