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

Primary Purpose

Advanced or Metastatic Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
apatinib
placebo
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced or Metastatic Gastric Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The 81 Hosiptal of PLA
  • Fudan University cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

apatinib

placebo

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival(PFS)
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).
Overall Survival(OS)
Overall Survival of the Participants

Secondary Outcome Measures

Disease Control Rate(DCR)
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.
Objective Response Rate(ORR)
Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)
Percentage of Participants With Adverse Events

Full Information

First Posted
January 13, 2012
Last Updated
August 30, 2016
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborators
Fudan University, The 81 Hospital of PLA
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1. Study Identification

Unique Protocol Identification Number
NCT01512745
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborators
Fudan University, The 81 Hospital of PLA

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced or Metastatic Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
apatinib
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
apatinib
Intervention Description
apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
Primary Outcome Measure Information:
Title
Progression Free Survival(PFS)
Description
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).
Time Frame
30 months
Title
Overall Survival(OS)
Description
Overall Survival of the Participants
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Disease Control Rate(DCR)
Description
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.
Time Frame
30 months
Title
Objective Response Rate(ORR)
Description
Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)
Time Frame
30 months
Title
Percentage of Participants With Adverse Events
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Li, MD, PHD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shukui Qin, MD
Organizational Affiliation
The 81 Hospital of PLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 81 Hosiptal of PLA
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Fudan University cancer hospital
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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