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

NCT01512745 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2016-10-17

Study results available
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Summary

Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival or overall survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.

Conditions

  • Advanced or Metastatic Gastric Cancer

Interventions

DRUG

apatinib

apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

DRUG

placebo

placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • The 81 Hospital of PLA

    collaborator UNKNOWN

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jin Li, MD, PHD · Fudan University

  • Shukui Qin, MD · The 81 Hospital of PLA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01512745 on ClinicalTrials.gov