Clinical trial NCT02944864: A Phase I Study of TQ-B3395 on Tolerance and Pharmacokinetics
Official title: Phase I Study of Tolerance and Pharmacokinetics of TQ-B3395 in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-10-26
Enrollment: 53
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-B3395 in the human body, recommend a reasonable regimen for subsequent research.


Eligibility criteria: 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

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

Primary outcomes:
measure: The maximum tolerated dose (MTD) of TQ-B3395
timeFrame: 48 weeks
measure: The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3395
timeFrame: For 4 weeks for DLTs.
measure: Pharmacokinetics of TQ-B3395 (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-B3395 (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-B3395 (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-B3395 (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-B3395 (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 56 days up to intolerance the toxicity or PD (up to 24 months)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: