A Phase I Study of TQ-B3101 on Tolerance and Pharmacokinetics

Advanced Cancer Clinical Trial

Official title:

Phase I Study of Tolerance and Pharmacokinetics of TQ-B3101 in Patients With Advanced Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03019276
• Other study ID #: TQ-B3101-1-0001
• Status: Recruiting
• Phase: Phase 1
• First received: January 10, 2017
• Last updated: September 15, 2017
• Start date: July 5, 2017
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: Hongming Pan, Doctor
• Phone: 0571-86960497
• Email: panhongming63[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the pharmacokinetic characteristics of TQ-B3101 in the human body, recommend a reasonable regimen for subsequent research.

Description:

single arm, single or repeat dosing of TQ-B3101 on patients with solid tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: December 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

• 18-70years,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:

• Patients with treatment failure by ALK/ROS1 inhibitor

• Patients with anti-teratment,radiotherapy or surgery within 4 weeks

• Patients participated in other anticancer drug clinical trials within 4 weeks or ALK/ROS1 inhibitor within 1 week

• Blood pressure unable to be controlled(systolic pressure>140 mmHg,diastolic pressure>90 mmHg). Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT=470ms)

• 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-B3101
Escalating doses of TQ-B3101 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 100 mg to 500 mg/day administered either once or twice a day. A treatment cycle is considered to be 28 days .

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University	Hangzhou	Zhejiang

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-B3101	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-B3101	Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug :III °or above of non-hematological toxicity,IV°hematological toxicity ,Neutropenia associated with fever	For 4 weeks for DLTs
Primary	Pharmacokinetics of TQ-B3101 (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 H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28(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-B3101 (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 H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28(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-B3101 (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 H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28(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-B3101 (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 H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28(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-B3101 (in whole blood):Clearance(CL)	Clearance(CL),CL in L/h.In the study of single-dose, full PK profiles will be obtained at H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28(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)	Percentage of participants with OR based assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).	each 28 days up to intolerance the toxicity or PD (up to 24 months)