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A Study of Anlotinib in Patients With Gastroenteropancreatic Neuroendocrine Tumor G3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03457844
Recruitment Status : Unknown
Verified March 2018 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..
Recruitment status was:  Recruiting
First Posted : March 8, 2018
Last Update Posted : September 11, 2018
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Gastroenteropancreatic Neuroendocrine Tumor G3 Drug: Anlotinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 30, 2019

Arm Intervention/treatment
Experimental: Anlotinib Drug: Anlotinib
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 Measures :
  1. Progression Free Survival(PFS) [ Time Frame: From randomization,each 42 days up to progressive disease(PD) or death(up to 24 months) ]

Secondary Outcome Measures :
  1. Objective Response Rate(ORR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]
  2. Overall survival(OS) [ Time Frame: From randomization until death (up to 24 months) ]
  3. Disease Control Rate(DCR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03457844

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Contact: Yihebali Chi, doctor 010-67781331

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China, Beijing
Yihebali Chi Recruiting
Beijing, Beijing, China, 100021
Contact: Yihebali Chi, doctor    010-67781331   
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Identifier: NCT03457844    
Other Study ID Numbers: ALTN-13-II
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases