Clinical trial NCT02752516: A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics
Official title: Phase I Additional Study of Tolerance and Pharmacokinetics of Anlotinib in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-04-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics.To further study the pharmacokinetic characteristics of Anlotinib in the human body, recommend a reasonable regimen for subsequent research.


Eligibility criteria: Inclusion Criteria:

* Histological documentation of Advanced solid tumors except the digestive tract tumors,at least one measurable lesion (by RECIST1.1)
* Lack of the standard treatment or treatment failure
* 18-65 years,ECOG PS:0-1,Life expectancy of more than 3 months
* 30 Days or more from the last cytotoxic therapy
* 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 who are used by anlotinib
* Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
* Brain metastases patients with symptoms or symptoms controlled \< 3 months
* Patients with any severe and/or unable to control diseases，including：

  1. Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
  2. Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥480ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);
  3. Patients with active or unable to control serious infections;
  4. Patients with cirrhosis, decompensated liver disease, or active hepatitis;
  5. Patients with poorly controlled diabetes (fasting blood glucose(FBG)\>10mmol/L)
  6. Urine protein ≥ ++，and 24-hour urinary protein excretion\>1.0 g confirmed
* Patients with non-healing wounds or fractures
* Patients with any CTC AE Grade 1 or higher bleeding events occurred in the lungs or any CTC AE Grade 2 or higher bleeding events occurred within 4 weeks prior to assignment;Patients with any physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation
* Patients with drug abuse history and unable to get rid of or Patients with mental disorders
* Patients participated in other anticancer drug clinical trials within 4 weeks
* 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: Pharmacokinetics of Anlotinib (in whole blood):Peak Plasma Concentration(Cmax)
timeFrame: up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of Anlotinib (in whole blood):Peak time（Tmax）
timeFrame: up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of Anlotinib (in whole blood):Half life（t1/2）
timeFrame: up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of Anlotinib (in whole blood):Area under the plasma concentration versus time curve (AUC)
timeFrame: up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of Anlotinib (in whole blood):Clearance（CL）
timeFrame: up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Cumulative excretion of Anlotinib (in urine)
timeFrame: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: each 42 days up to intolerance the toxicity or PD(Disease progression) (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: