Status:
COMPLETED
Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsors:
Fudan University
The 81 Hospital of PLA
Conditions:
Advanced or Metastatic Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT01512745
Start Date
January 1 2011
End Date
May 1 2013
Last Update
October 17 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The 81 Hosiptal of PLA
Nanjing, Jiangsu, China
2
Fudan University cancer hospital
Shanghai, Shanghai Municipality, China