A Randomized Phase 2/3 Study of Apatinib as Third Line Treatment in Patients With Metastatic Gastric Carcinoma
Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have
been suggested as the first line therapy for A/MGC by FDA, the efficacy of these treatment
is still unsatisfied for their toxicity and limitation in prolonging survival. Based on the
promising results of apatinib in the phase I study, this clinical trial has been designed to
evaluate whether apatinib can improve progression free survival in patients with metastatic
gastric carcinoma who failed two lines of chemotherapy compared with placebo. Patients will
be randomized to 3 groups, one group patients will receive the treatment of apatinib 850mg
qd, one group patients will receive apatinib 425mg bid, and the other group will receive
placebo.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression free survival
8 weeks
Yes
Jin Li, MD, PHD
Principal Investigator
Fudan University
China: Ethics Committee
2009APA-MGC
NCT00970138
June 2009
December 2010
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