NCT03019276

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

July 5, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 18, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

January 10, 2017

Last Update Submit

September 15, 2017

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (1)

  • Objective Response Rate(ORR)

    each 28 days up to intolerance the toxicity or PD (up to 24 months)

Study Arms (1)

TQ-B3101

EXPERIMENTAL

TQ-B3101 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Drug: TQ-B3101

Interventions

TQ-B3101DRUG

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 .

TQ-B3101

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological documentation of Advanced solid tumors
  • Lack of the standard treatment or treatment failure
  • 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:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310016, China

RECRUITING

Related Publications (1)

  • Lu S, Pan H, Wu L, Yao Y, He J, Wang Y, Wang X, Fang Y, Zhou Z, Wang X, Cai X, Yu Y, Ma Z, Min X, Yang Z, Cao L, Yang H, Shu Y, Zhuang W, Cang S, Fang J, Li K, Yu Z, Cui J, Zhang Y, Li M, Wen X, Zhang J, Li W, Shi J, Xu X, Zhong D, Wang T, Zhu J. Efficacy, safety and pharmacokinetics of Unecritinib (TQ-B3101) for patients with ROS1 positive advanced non-small cell lung cancer: a Phase I/II Trial. Signal Transduct Target Ther. 2023 Jun 30;8(1):249. doi: 10.1038/s41392-023-01454-z.

    PMID: 37385995DERIVED

Central Study Contacts

Hongming Pan, Doctor

CONTACT

0571-86960497panhongming63@163.com

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

January 10, 2017

First Posted

January 12, 2017

Study Start

July 5, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

September 18, 2017

Record last verified: 2017-01

Locations

CN(1)