ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase I Study of TQ-B3395 on Tolerance and Pharmacokinetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02944864
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Brief Summary:
To study the pharmacokinetic characteristics of TQ-B3395 in the human body, recommend a reasonable regimen for subsequent research.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: TQ-B3395 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Tolerance and Pharmacokinetics of TQ-B3395 in Patients With Advanced Cancer
Actual Study Start Date : August 13, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: TQ-B3395
TQ-B3395 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: TQ-B3395
TQ-B3395 p.o. qd




Primary Outcome Measures :
  1. The maximum tolerated dose (MTD) of TQ-B3395 [ Time Frame: 48 weeks ]
    The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment

  2. The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3395 [ Time Frame: For 4 weeks for DLTs. ]
    Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug :II °or above of kidney damage,III °or above of non-hematological toxicity,IV°hematological toxicity ,Neutropenia associated with fever

  3. Pharmacokinetics of TQ-B3395 (in whole blood):Peak Plasma Concentration(Cmax) [ Time Frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) ]
    Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21(D means Day).

  4. Pharmacokinetics of TQ-B3395 (in whole blood):Peak time(Tmax) [ Time Frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) ]
    Peak time(Tmax),Tmax in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21(D means Day)

  5. Pharmacokinetics of TQ-B3395 (in whole blood):Half life(t1/2) [ Time Frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) ]
    Half life(t1/2),t1/2 in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21(D means Day)

  6. Pharmacokinetics of TQ-B3395 (in whole blood):Area under the plasma concentration versus time curve (AUC) [ Time Frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) ]
    Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21(D means Day)

  7. Pharmacokinetics of TQ-B3395 (in whole blood):Clearance(CL) [ Time Frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) ]
    Clearance(CL),CL in L/h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21(D means Day)


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: each 56 days up to intolerance the toxicity or PD (up to 24 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological documentation of Advanced solid tumors,lack of the standard treatment or treatment failure.In expanding stage,enroll the Non-small Cell Lung Cancer with EGFR+(except exon 20)
  • 18-70 years,ECOG PS:0-1,Life expectancy of more than 3 months
  • 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 participate in the study voluntarily and sign informed consent

Exclusion Criteria:

  • 14 Days or more from the last cytotoxic therapy
  • Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now
  • Blood pressure unable to be controlled ideally by one drug(systolic pressure≥140 mmHg,diastolic pressure≥90 mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥470ms) and patients with Grade 3 or higher congestive heart failure (NYHA Classification)
  • Patients with non-healing wounds or fractures
  • Patients with drug abuse history and unable to get rid of or Patients with mental disorders
  • History of immunodeficiency
  • Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944864


Contacts
Contact: Jie Wang, doctor zlhuxi@163.com

Locations
China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Jie Wang, doctor         
Sponsors and Collaborators
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Responsible Party: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT02944864     History of Changes
Other Study ID Numbers: TQ-B3395-I-0001
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No