Apatinib as Maintenance Therapy After First Line Treatment in Locally Advanced or Metastatic Gastric Cancer

NCT02537171 | Unknown Phase 3 DMC

• 1 other identifier: AHEAD-G303
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to evaluate the efficacy of Apatinib in patients with advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction.

Conditions

Gastric Cancer

Keywords

Apatinib; Locally Advanced Gastric Cancer; Metastatic Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.

  1 year

Secondary Outcomes (5)

• disease control rate(DCR）

  1year

• Objective tumor response rate(ORR)

  1year

• overall survival(OS)

  3year

• Quality of life score （QoL）

  1year

• Adverse Events(AEs)

  1year

Study Arms (2)

Apatinib 750mg group

ACTIVE COMPARATOR

Apatinib mesylate tablets(ATAN) is taken 750mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death.The dose of the study drug may be modified following the occurence of a clinically significant adverse event(AE).

Drug: apatinib

Apatinib 500mg group

ACTIVE COMPARATOR

Apatinib Mesylate Tablets(ATAN) is taken 500mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death.Treatment will be discontinued if the subject is unable to tolerate a daily dose of 500mg.

Drug: apatinib

Interventions

apatinib DRUG

Patients will be randomly assigned on a 1:1 basis to treatment with Apatinib 750mg group or Apatinib 500mg group.

Also known as: ATAN

Apatinib 500mg group; Apatinib 750mg group

Eligibility Criteria

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

You may qualify if:

• Age≥18 years;
• Pathologically diagnosed with advanced gastric adenocarcinoma (including gastroesophageal junction) with measurable metastases outside the stomach (≥10mm on spiral CT scan, and meet the criteria of Response Evaluation Criteria in Solid Tumors 1.1);
• Locally advanced, recurrent or metastatic gastric or gastro-oesophageal junction adenocarcinoma;
• Finished first-line chemotherapy (fluorouracil combined with oxaliplatin, cisplatin, paclitaxel or docetaxel) 3 weeks a cycle for 4 cycles, of which the last efficacy assessment is SD, PR or CR. No more than 28 days from the starting day of last cycle of chemotherapy;
• Eastern Cooperative Oncology Group（ECOG）performance status 0 or 1;
• Blood routine test and Biochemical tests:
• Hemoglobin ≥ 80g / L;
• Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L;
• Platelet count≥ 90 × 109 / L;
• Alanine aminotransferase (ALT)and Aspartate aminotransferase (AST) \<2.5× upper limit of normal (ULN); liver metastases, if any, the ALT and AST\<5 × ULN;
• Serum total bilirubin≤1.5 × ULN;
• Serum creatinine≤1.5 × ULN;
• Serum albumin≥30g/L;
• Life expectancy more than 3 months;
• Voluntarily join the study and sign the Informed Consent Form for the study;

You may not qualify if:

• Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories;
• 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 ClassⅠ; Ⅰ-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class Ⅰcardiac dysfunction; Patients with positive urinary protein;
• Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
• 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 haematemesis in the past 2 months;primary lesion in stomach with positive fecal occult blood test (+) should be evaluated by endoscopy and other potential massive haemorrhage conditions evaluated by the investigator;
• Abnormal Coagulation (international normalized ratio\>1.5, activated partial thromboplastin time\>1.5 UNL), with tendency of bleeding;
• Associated with central nervous system (CNS) metastases;
• Pregnant or lactating women;
• Suffering from other malignancies within 5 years;
• History of uncontrolled psychotropic drug abuse or mental disorders;
• Participated in other clinical study within 4 weeks;
• Prior VEGFR inhibitor treatment,such as sorafenib and sunitinib ;
• Concomitant disease conditions judged by investigator that may seriously affect subject's safety or affect the study completion;
• Other cases that the researcher found ineligible

Sponsors & Collaborators

• The Affiliated Hospital of the Chinese Academy of Military Medical Sciences: lead

Study Sites (1)

307 Hospital of PLA

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Xu jianming, M.D.

  307 Hospital of PLA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu jianming, M.D.

CONTACT

+861066947178; jmxu2003@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: September 1, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 2, 2016

Record last verified: 2015-08

Locations

CN (1)