Phase 3
N=267
Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
Advanced or Metastatic Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01512745 ↗Enrolled (actual)
267
Serious AEs
4.5%
Results posted
Jun 2016
Primary outcome: Primary: Progression Free Survival(PFS) — 2.6; 1.8 month
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- apatinib (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival(PFS) |
2.6; 1.8 | — |
| PRIMARY Overall Survival(OS) |
6.5; 4.7 | — |
| SECONDARY Disease Control Rate(DCR) |
42.05; 8.79 | — |
| SECONDARY Objective Response Rate(ORR) |
2.84; 0.00 | — |
| SECONDARY Percentage of Participants With Adverse Events |
98.30; 90.11 | — |
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 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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT01512745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.