A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics

CTTQ

Status and phase

Unknown

Phase 1

Conditions

Cancer

Treatments

Drug: Anlotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02752516

ALTN-I-07

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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