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

Advanced Cancer Clinical Trial

Official title:

Phase I Study of Tolerance and Pharmacokinetics of TQ-B3395 in Patients With Advanced Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02944864
• Other study ID #: TQ-B3395-I-0001
• Status: Recruiting
• Phase: Phase 1
• First received: October 24, 2016
• Last updated: September 15, 2017
• Start date: August 13, 2017
• Est. completion date: October 2018

Study information

• Verified date: December 2016
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: Jie Wang, doctor
• Email: zlhuxi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Drug:
• TQ-B3395
TQ-B3395 p.o. qd

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum tolerated dose (MTD) of TQ-B3395	The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment	48 weeks
Primary	The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3395	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	For 4 weeks for DLTs.
Primary	Pharmacokinetics of TQ-B3395 (in whole blood):Peak Plasma Concentration(Cmax)	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).	up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Primary	Pharmacokinetics of TQ-B3395 (in whole blood):Peak time(Tmax)	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)	up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Primary	Pharmacokinetics of TQ-B3395 (in whole blood):Half life(t1/2)	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)	up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Primary	Pharmacokinetics of TQ-B3395 (in whole blood):Area under the plasma concentration versus time curve (AUC)	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)	up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Primary	Pharmacokinetics of TQ-B3395 (in whole blood):Clearance(CL)	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)	up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Secondary	Objective Response Rate (ORR)		each 56 days up to intolerance the toxicity or PD (up to 24 months)