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

Hengrui Medicine

Status and phase

Completed

Phase 3

Conditions

Advanced or Metastatic Gastric Cancer

Treatments

Drug: placebo

Drug: apatinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01512745

HENGRUI 20101208

Details and patient eligibility

About

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.

Enrollment

267 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥ 18 and ≤ 70 years of age
Histological confirmed advanced or metastatic adenocarcinoma of the stomach
Have failed for at least 2 lines of chemotherapy
Life expectancy of at least 12 weeks.
Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 1 week before randomization.
At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan)
Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
More than 4 weeks for operation or radiotherapy
More than 4 weeks for cytotoxic agents or growth inhibitors
Adequate hepatic, renal, heart, and hematologic functions (HB ≥ 90g/L,platelets > 80 ×10 E+9/L, neutrophil > 1.5 × 10 E+9/L, serum creatinine ≤ 1× upper limit of normal(ULN), bilirubin < 1.25× ULN, and serum transaminase ≤ 2.5× ULN).

Exclusion criteria

Pregnant or lactating women
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).
Any factors that influence the usage of oral administration; Evidence of Central Nerves System(CNS) metastasis
Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure and proteinuria ≥ (+)
International Normalize Ratio (INR) > 1.5 and activated partial thromboplastin time（APPT） > 1.5 × ULN
Abuse of alcohol or drugs
Certain possibility of gastric or intestine hemorrhage
Less than 4 weeks from the last clinical trial
Prior VEGFR inhibitor treatment
Disability of serious uncontrolled intercurrence infection Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc.