A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics

NCT02752516 | Unknown Phase 1

• 1 other identifier: ALTN-I-07
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (6)

• Pharmacokinetics of Anlotinib (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/H4/H8/H11/H24/H48/H72/H120/H168/H240（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle（D means Day）.

  up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

• Pharmacokinetics of Anlotinib (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/H4/H8/H11/H24/H48/H72/H120/H168/H240(H means hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day).

  up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

• Pharmacokinetics of Anlotinib (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/H4/H8/H11/H24/H48/H72/H120/H168/H240(H mans Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day).

  up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

• Pharmacokinetics of Anlotinib (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/H4/H8/H11/H24/H48/H72/H120/H168/H240(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day).

  up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

• Pharmacokinetics of Anlotinib (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/H4/H8/H11/H24/H48/H72/H120/H168/H240(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day).

  up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

• Cumulative excretion of Anlotinib (in urine)

  up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)

Secondary Outcomes (1)

• Objective Response Rate (ORR)

  each 42 days up to intolerance the toxicity or PD(Disease progression) (up to 24 months)

Study Arms (1)

Anlotinib

EXPERIMENTAL

Drug: Anlotinib

Interventions

Anlotinib DRUG

Anlotinib QD po. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Anlotinib

Eligibility Criteria

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

You may qualify if:

• 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
• years,ECOG PS:0-1,Life expectancy of more than 3 months
• 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

You may not qualify if:

• 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：
• Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
• 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);
• Patients with active or unable to control serious infections;
• Patients with cirrhosis, decompensated liver disease, or active hepatitis;
• Patients with poorly controlled diabetes (fasting blood glucose(FBG)\>10mmol/L)
• 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

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

MeSH Terms

Conditions

Neoplasms

Interventions

anlotinib

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: April 25, 2016
• First Posted: April 27, 2016
• Study Start: April 27, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 18, 2017

Record last verified: 2017-04

Locations

CN (1)