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
  Purpose

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.


Condition Intervention Phase
Advanced or Metastatic Gastric Cancer
Drug: apatinib
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Jiangsu HengRui Medicine Co., Ltd.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 273
Study Start Date: January 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: apatinib Drug: apatinib
apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
Placebo Comparator: placebo Drug: placebo
placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 ×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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512745

Locations
China, Jiangsu
The 81 Hosiptal of PLA
Nanjing, Jiangsu, China
China, Shanghai
Fudan University cancer hospital
Shanghai, Shanghai, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Fudan University
The 81 Hospital of PLA
Investigators
Principal Investigator: Jin Li, MD, PHD Fudan University
Principal Investigator: Shukui Qin, MD The 81 Hospital of PLA
  More Information

No publications provided

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT01512745     History of Changes
Other Study ID Numbers: HENGRUI 20101208
Study First Received: January 13, 2012
Last Updated: April 2, 2015
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on September 01, 2015