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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Fudan University
NanJing PLA 81 Hospital
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01512745
First received: January 13, 2012
Last updated: January 24, 2012
Last verified: January 2012

January 13, 2012
January 24, 2012
January 2011
June 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01512745 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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.
 
Recruiting
270
June 2012
June 2012   (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 2 lines of chemotherapy
  • Life expectancy of more than 3 months
  • ECOG performance scale ≤ 1
  • 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 (platelets > 80 × 109/L, neutrophil > 1.5 × 109/L, serum creatinine ≤ 1X 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
  • Any factors that influence the usage of oral administration; Evidence of CNS metastasis
  • Intercurrence with one of the following: uncontrolled hypertension, coronary artery disease, arrhythmia and heart failure
  • INR > 1.5 and APPT > 1.5 X 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.
Both
18 Years to 70 Years
No
Contact: jin Li, MD, PHD +86-21-64175590 fudanlijin@163.com
China
 
NCT01512745
HENGRUI 20101208
Yes
Jiangsu HengRui Medicine Co., Ltd.
Jiangsu HengRui Medicine Co., Ltd.
  • Fudan University
  • NanJing PLA 81 Hospital
Principal Investigator: jin Li, MD, PHD Fudan University
Principal Investigator: Shukui Qin, MD Nanjin Military Eighty -one Hosiptal
Jiangsu HengRui Medicine Co., Ltd.
January 2012

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