Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics

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: 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

Relevance to patient case: not relevant