Clinical trial NCT03019276: A Phase I Study of TQ-B3101 on Tolerance and Pharmacokinetics
Official title: Phase I Study of Tolerance and Pharmacokinetics of TQ-B3101 in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: The maximum tolerated dose (MTD) of TQ-B3101
timeFrame: 48 weeks
measure: The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3101
timeFrame: For 4 weeks for DLTs
measure: Pharmacokinetics of TQ-B3101 (in whole blood):Peak Plasma Concentration(Cmax)
timeFrame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of TQ-B3101 (in whole blood):Peak time（Tmax）
timeFrame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of TQ-B3101 (in whole blood):Half life（t1/2）
timeFrame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of TQ-B3101 (in whole blood):Area under the plasma concentration versus time curve (AUC)
timeFrame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of TQ-B3101 (in whole blood):Clearance（CL）
timeFrame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Secondary outcomes:
measure: Objective Response Rate(ORR)
timeFrame: each 28 days up to intolerance the toxicity or PD (up to 24 months)
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: