search
Back to results

A Study of Anlotinib in Patients With Gastroenteropancreatic Neuroendocrine Tumor G3

Primary Purpose

Gastroenteropancreatic Neuroendocrine Tumor G3

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroenteropancreatic Neuroendocrine Tumor G3

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Yihebali ChiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anlotinib

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival(PFS)

Secondary Outcome Measures

Objective Response Rate(ORR)
Overall survival(OS)
Disease Control Rate(DCR)

Full Information

First Posted
February 27, 2018
Last Updated
September 7, 2018
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03457844
Brief Title
A Study of Anlotinib in Patients With Gastroenteropancreatic Neuroendocrine Tumor G3
Official Title
A Single Group, Open Label, Multi-center Clinical Trial to Assess the Efficacy and Safety of Anlotinib in Patients With Gastroenteropancreatic Neuroendocrine Tumor G3
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Anticipated)
Study Completion Date
August 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteropancreatic Neuroendocrine Tumor G3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anlotinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression Free Survival(PFS)
Time Frame
From randomization,each 42 days up to progressive disease(PD) or death(up to 24 months)
Secondary Outcome Measure Information:
Title
Objective Response Rate(ORR)
Time Frame
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Title
Overall survival(OS)
Time Frame
From randomization until death (up to 24 months)
Title
Disease Control Rate(DCR)
Time Frame
each 42 days up to intolerance the toxicity or PD (up to 24 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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; 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yihebali Chi, doctor
Phone
010-67781331
Email
dryihebalichi@126.com
Facility Information:
Facility Name
Yihebali Chi
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yihebali Chi, doctor
Phone
010-67781331
Email
dryihebalichi@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Anlotinib in Patients With Gastroenteropancreatic Neuroendocrine Tumor G3

We'll reach out to this number within 24 hrs