Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

apatinib 850 mg qd, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

apatinib 425 mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

placebo bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

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

apatinib tablet

Jin Li, MD, PHD

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.

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.

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

A Randomized Phase 2/3 Study of Apatinib as Third Line Treatment in Patients With Metastatic Gastric Carcinoma

Fudan University

Jin Li/Dr

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer	NCT00970138	Gastric Carcino...	apatinib tablet	18 Years - 70 Years	Fudan University
Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer	NCT00970138	Gastric Carcino...	apatinib tablet	18 Years - 70 Years	Fudan University
Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer	NCT00970138	Gastric Carcino...	apatinib tablet	18 Years - 70 Years	Fudan University

Spots Global Cancer Trial Database for progress free survival