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

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ClinicalTrials.gov Identifier: NCT01512745
Recruitment Status : Completed
First Posted : January 19, 2012
Results First Posted : June 15, 2016
Last Update Posted : October 17, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2011
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Progression Free Survival(PFS) [ Time Frame: 30 months ]
    Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

  2. Overall Survival(OS) [ Time Frame: 30 months ]
    Overall Survival of the Participants


Secondary Outcome Measures :
  1. Disease Control Rate(DCR) [ Time Frame: 30 months ]
    Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks.

  2. Objective Response Rate(ORR) [ Time Frame: 30 months ]
    Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)

  3. Percentage of Participants With Adverse Events [ Time Frame: 30 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 ×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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT01512745     History of Changes
Other Study ID Numbers: HENGRUI 20101208
First Posted: January 19, 2012    Key Record Dates
Results First Posted: June 15, 2016
Last Update Posted: October 17, 2016
Last Verified: April 2015

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