Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer

Sponsor
Fudan University
Study ID
NCT00970138
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Gastric Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • apatinib tablet — DRUG
    A850: apatinib 850 mg qd p.o. plus placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent B425: apatinib 425 mg bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent Cpla: placebo bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

Study Details

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 compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.

Key Dates

Start date
Jun 30, 2009
Status verified
Sep 2010
Primary completion
Oct 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
141 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A 850
    apatinib 850 mg qd, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
  • Experimental: B 425
    apatinib 425 mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
  • Placebo Comparator: C pla
    placebo bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Primary Outcome Measure

Progression free survival [ Time Frame: 8 weeks ]

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