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

This study has been completed.
Sponsor:
Collaborators:
Fudan University
The 81 Hospital of PLA
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01512745
First received: January 13, 2012
Last updated: April 2, 2015
Last verified: April 2015

January 13, 2012
April 2, 2015
January 2011
May 2013   (final data collection date for primary outcome measure)
  • PFS [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
    Progression free survival
  • OS [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
    Overall Survival
  • PFS [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Progression free survival
  • OS [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Overall Survival
Complete list of historical versions of study NCT01512745 on ClinicalTrials.gov Archive Site
  • DCR [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    Disease control rate
  • ORR [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    objective response rate
  • QoL [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
    quality of life
  • Toxicity [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • DCR [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Disease control rate
  • ORR [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    objective response rate
  • QoL [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    quality of life
  • Toxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
A Randomized, Double Blinded, Placebo Controlled Multicenter Phase III Study of Apatinib Mesylate Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Advanced or Metastatic Gastric Cancer
  • Drug: apatinib
    apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
  • Drug: placebo
    placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
  • Experimental: apatinib
    Intervention: Drug: apatinib
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
273
May 2013
May 2013   (final data collection date for primary outcome measure)

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 ×10E+9/L, neutrophil > 1.5 × 10E+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 CNS metastasis
  • Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure and proteinuria ≥ (+)
  • INR > 1.5 and 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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01512745
HENGRUI 20101208
Yes
Jiangsu HengRui Medicine Co., Ltd.
Jiangsu HengRui Medicine Co., Ltd.
  • Fudan University
  • The 81 Hospital of PLA
Principal Investigator: Jin Li, MD, PHD Fudan University
Principal Investigator: Shukui Qin, MD The 81 Hospital of PLA
Jiangsu HengRui Medicine Co., Ltd.
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP