Overview

A Study of Anlotinib in Patients With Gastroenteropancreatic Neuroendocrine Tumor G3

Status:
Unknown status
Trial end date:
2019-08-30
Target enrollment:
0
Participant gender:
All
Summary
To assess the primary effects and safety of Anlotinib in patients with Gastroenteropancreatic Neuroendocrine Tumor G3.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
Criteria
Inclusion Criteria:

- Patients should participate in the study voluntarily and sign informed consent;

- 18-75 years old;

- Histopathological proven diagnosis of high grade (G3) advanced Gastroenteropancreatic
Neuroendocrine Tumor(Unresectable locally advanced or distant Metastatic). the
classification is based on the Ki-67 proliferative index >20%(WHO 2010),and Provision
of qualified pathological tissue for central review;

- Progression during or after treatment with first-line systematic chemotherapy;

- At least one measurable nidus (by RECIST1.1);

- Main organs function is normal;

- Eastern Cooperative Oncology Group(ECOG) performance status(PS):0-1,Life expectancy of
more than 12 weeks;

- 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;

Exclusion Criteria:

- Diagnosed with low or intermediate (G1,G2) neuroendocrine tumors, Manec,
adenocarcinoma;

- Functional neuroendocrine tumors(NETs) which need to be treated with long acting
somatostatin analogue(SSAs) to control disease related syndromes, such as insulinoma,
gastrinoma, glucagonoma, somatostatinoma, accompanied by carcinoid syndrome,
Zollinger-Ellison syndrome or other active symptoms;

- Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma
or cervical carcinoma in situ after radical resection;

- Have received anti-vascular endothelial growth factor(VEGF)/VEGFR targeted drugs and
progressed upon these drugs;

- Patients with factors that could affect oral medication (such as dysphagia,chronic
diarrhea, intestinal obstruction etc.)

- 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>1.0g confirmed;

- Patients had surgery (except biopsy) within 28 days or the surgical incision has not
fully healed before the first study drug implementation;

- Patients with brain metastasis or spinal cord compression which had not surgical and /
or radiation therapy,or which had previous treatment but there is no clinical imaging
evidence proving the condition is stable;

- Anti-tumor therapy was performed within 4 weeks prior to initiation of the study
treatment, including but not limited to chemotherapy, radical radiotherapy,
bio-targeted therapy, immunotherapy, anti-tumor treatment of traditional Chinese
medicine, hepatic artery embolization, hepatic metastatic cryoablation or
radiofrequency ablation surgery.Palliative radiotherapy for a bone metastasis lesion
within 2 weeks prior to the initiation of the investigational treatment;

- The toxic reaction of previous anticancer treatment has not been restored to grade 0
or 1 (except hair loss);

- Patients with arterial or venous thromboembolic events occurred within 6 months, such
as cerebrovascular accident (including transient ischemic attack), deep vein
thrombosis and pulmonary embolism;

- Imaging showed tumors have involved important blood vessels or by investigators
determine likely during the follow-up study and cause fatal hemorrhage;

- 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;

- Pregnancy(Positive detection of pregnancy before drug use)or lactation;

- Patients with concomitant diseases which could seriously endanger their own safety or
could affect completion of the study according to investigators' judgment;