Clinical trial NCT01512745: Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
Official title: A Randomized, Double Blinded, Placebo Controlled Multicenter Phase III Study of Apatinib Mesylate Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced or Metastatic Gastric Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Fudan University
name: The 81 Hospital of PLA
First posted: 2012-01-19
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 \< 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.

Primary outcomes:
measure: Progression Free Survival(PFS)
timeFrame: 30 months
measure: Overall Survival(OS)
timeFrame: 30 months
Secondary outcomes:
measure: Disease Control Rate(DCR)
timeFrame: 30 months
measure: Objective Response Rate(ORR)
timeFrame: 30 months
measure: Percentage of Participants With Adverse Events
timeFrame: 30 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The 81 Hosiptal of PLA
state: Jiangsu
city: Shanghai
country: China
facility: Fudan University cancer hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jin Li, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: The 81 Hospital of PLA
name: Shukui Qin, MD
role: PRINCIPAL_INVESTIGATOR
References: