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

Phase 1

• Conditions: Advanced Cancer
• Interventions: Drug: TQ-B3395

• Registration Number: NCT02944864
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Status Verified: 2016-12
• Study Start: 2017-08-13
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-18
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TQ-B3395	TQ-B3395	TQ-B3395 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Primary Outcome Measures

Name	Time	Method
The maximum tolerated dose (MTD) of TQ-B3395	48 weeks	The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment
Pharmacokinetics of TQ-B3395 (in whole blood):Peak time（Tmax）	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）
Pharmacokinetics of TQ-B3395 (in whole blood):Clearance（CL）	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）
Pharmacokinetics of TQ-B3395 (in whole blood):Half life（t1/2）	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）
Pharmacokinetics of TQ-B3395 (in whole blood):Area under the plasma concentration versus time curve (AUC)	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）
The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3395	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
Pharmacokinetics of TQ-B3395 (in whole blood):Peak Plasma Concentration(Cmax)	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）.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	each 56 days up to intolerance the toxicity or PD (up to 24 months)

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China