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Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

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.
 
ClinicalTrials.gov Identifier: NCT02426034
Recruitment Status : Unknown
Verified April 2016 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Recruiting
First Posted : April 24, 2015
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
The purpose of this single arm study is to assess the safety and efficacy of ATAN (Apatinib) in patients with Chemo-refractory Advanced or Metastatic Adenocarcinoma of Stomach or Gastroesophageal Junction in clinical practice. ATAN will be given to patients who had failed at least two lines of prior chemotherapy. Eligible patients will receive ATAN treatment (850 mg qd p.o.) continually until disease progression or intolerable toxicity or patients withdrawal of consent, and the target sample size is 2000+ individuals.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Apatinib Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single Group Assigned, Multicenter Study of Apatinib in Patients With Chemo-refractory Advanced or Metastatic Adenocarcinoma of Stomach or Gastroesophageal Junction
Study Start Date : February 2015
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Apatinib(ATAN)
apatinib 850 mg qd p.o.
Drug: Apatinib
Apatinib Mesylate Tablets 850 mg qd p.o. The observation period is 28 days
Other Name: ATAN




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Adverse events will be assessed at baseline (after the patients provided signed Informed Consent Form) until at least 4 weeks after the last dose of study drug was administered, an expected average of 14 weeks ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Event driven, an expected average of 34 weeks ]
  2. Progression Free Survival [ Time Frame: An expected average of 12 weeks ]
  3. Objective Response Rate [ Time Frame: An expected average of 12 weeks ]
  4. Disease Control Rate [ Time Frame: An expected average of 12 weeks ]
  5. Quality of life [ Time Frame: Quality of life will be assessed at baseline (after the patients provided written informed consent) until at least 4 weeks after the last dose of study drug was administered, an expected average of 14 weeks ]


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
Criteria

Inclusion Criteria:

  1. Age: 18 to75 years old;
  2. Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the gastroesophageal junction) with measurable metastases outside the stomach (measuring ≥ 10mm on spiral CT scan, satisfying the criteria in RECIST 1.1);
  3. Failure of prior therapy (during or after treatment) in patients who have received at least two prior chemotherapy regimens;
  4. ECOG PS of 0-2;
  5. Major organ function has to meet the following criteria:

    For results of blood routine test (without blood transfusion within 14 days):

    • HB ≥ 90g / L
    • ANC ≥ 1.5 × 109 / L
    • PLT ≥ 80 × 109 / L

    Biochemical tests results:

    • Bilirubin <1.25 times the upper limit of normal (ULN)
    • ALT and AST <2.5 × ULN; liver metastases, if any, the ALT and AST<5 × ULN
    • Serum Cr ≤ 1 × ULN endogenous creatinine clearance>50ml/min (Cockcroft-Gault formula)
  6. An expected survival of ≥ 3 months;
  7. Patient received apatinib treatment regimen at investigators' discretion;
  8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
  9. Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug.

Exclusion Criteria:

  1. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassII; II-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class II cardiac dysfunction;
  2. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
  3. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 3 months;unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy result;
  4. Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
  5. Associated with CNS (central nervous system) metastases;
  6. Pregnant or lactating women;
  7. Other conditions regimented at investigators' discretion.

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 ClinicalTrials.gov identifier (NCT number): NCT02426034


Contacts
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Contact: Shukui Qin, MD 025-80864542 qinsk@csco.org.cn

Locations
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China, Jiangsu
Nanjin Military 81 Hosiptal Recruiting
Nanjing, Jiangsu, China
Contact: Shukui Qin    025-80864542    qinsk@csco.org.cn   
Principal Investigator: Shukui Qin, MD.         
China, Shanghai
Fudan University cancer hospital Recruiting
Shanghai, Shanghai, China, 200000
Contact: Jin Li, MD    +86-21-64175590    fudanlijin@163.com   
Principal Investigator: JIN LI, MD         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Jin Li, MD Fudan University

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02426034    
Other Study ID Numbers: Ahead-G201
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Advanced
Metastatic
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action