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

NCT02944864 | Terminated Phase 1

• 1 other identifier: TQ-B3395-I-0001
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (7)

• 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

• 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.

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (1)

• Objective Response Rate (ORR)

  each 56 days up to intolerance the toxicity or PD (up to 24 months)

Study Arms (1)

TQ-B3395

EXPERIMENTAL

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

Drug: TQ-B3395

Interventions

TQ-B3395 DRUG

TQ-B3395 p.o. qd

TQ-B3395

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 26, 2016
• Study Start: September 13, 2017
• Primary Completion: May 23, 2021
• Study Completion: September 15, 2022
• Last Updated: September 23, 2024

Record last verified: 2016-12

Locations

CN (1)