A Study of Anlotinib in Patients With Gastroenteropancreatic Neuroendocrine Tumor G3

NCT03457844 | Unknown Phase 2

• 1 other identifier: ALTN-13-II
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the primary effects and safety of Anlotinib in patients with Gastroenteropancreatic Neuroendocrine Tumor G3.

Conditions

Gastroenteropancreatic Neuroendocrine Tumor G3

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival(PFS)

  From randomization，each 42 days up to progressive disease(PD) or death(up to 24 months)

Secondary Outcomes (3)

• Objective Response Rate(ORR)

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

• Overall survival(OS)

  From randomization until death (up to 24 months)

• Disease Control Rate(DCR)

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

Study Arms (1)

Anlotinib

EXPERIMENTAL

Drug: Anlotinib

Interventions

Anlotinib DRUG

Anlotinib is followed Day 1 to day 14 by 7 days off treatment in a 21-day cycle） and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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：
• 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\>1.0g 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Yihebali Chi

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Interventions

anlotinib

Central Study Contacts

Yihebali Chi, doctor

CONTACT

010-67781331; dryihebalichi@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 8, 2018
• Study Start: January 30, 2018
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: September 11, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)