search
Back to results

Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer

Primary Purpose

Gastric Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
apatinib tablet
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Carcinoma focused on measuring Progress free survival, Toxicity, Response rate, Overall survival, Quality of live

Eligibility Criteria

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

Inclusion Criteria:

  • ≥ 18 and ≤ 70 years of age
  • Histologically 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 ≤ 2
  • At least one measurable lesion (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 > 2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the 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
  • History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
  • Receiving the therapy of thrombolysis or anticoagulation
  • Abuse of alcohol or drugs
  • Allergy to the ingredient of the agent or more than two kinds of food and drug
  • Less than 4 weeks from the last clinical trial
  • Disability of serious uncontrolled intercurrence infection.

Sites / Locations

  • Fudan University Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A 850

B 425

C pla

Arm Description

apatinib 850 mg qd, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

apatinib 425 mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

placebo bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall survival safety
DCR (Disease control rate)
ORR (Objective response rate)
QoL (Quality of life)
Toxicity

Full Information

First Posted
September 1, 2009
Last Updated
July 11, 2011
Sponsor
Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT00970138
Brief Title
Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer
Official Title
A Randomized Phase 2/3 Study of Apatinib as Third Line Treatment in Patients With Metastatic Gastric Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
No

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 compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.
Detailed Description
Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, the efficacy of these treatment is still unsatisfied for their toxicity and limitation in prolonging survival. Based on the promising results of apatinib in the phase I study, this clinical trial has been designed to evaluate whether apatinib can improve progression free survival in patients with metastatic gastric carcinoma who failed two lines of chemotherapy compared with placebo. Patients will be randomized to 3 groups, one group patients will receive the treatment of apatinib 850mg qd, one group patients will receive apatinib 425mg bid, and the other group will receive placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Carcinoma
Keywords
Progress free survival, Toxicity, Response rate, Overall survival, Quality of live

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A 850
Arm Type
Experimental
Arm Description
apatinib 850 mg qd, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Arm Title
B 425
Arm Type
Experimental
Arm Description
apatinib 425 mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Arm Title
C pla
Arm Type
Placebo Comparator
Arm Description
placebo bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Intervention Type
Drug
Intervention Name(s)
apatinib tablet
Intervention Description
A850: apatinib 850 mg qd p.o. plus placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent B425: apatinib 425 mg bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent Cpla: placebo bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Overall survival safety
Time Frame
8 weeks
Title
DCR (Disease control rate)
Time Frame
8 weeks
Title
ORR (Objective response rate)
Time Frame
8 weeks
Title
QoL (Quality of life)
Time Frame
8 weeks
Title
Toxicity
Time Frame
8 weeks

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 Histologically 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 ≤ 2 At least one measurable lesion (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 > 2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the 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 History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure Receiving the therapy of thrombolysis or anticoagulation Abuse of alcohol or drugs Allergy to the ingredient of the agent or more than two kinds of food and drug Less than 4 weeks from the last clinical trial Disability of serious uncontrolled intercurrence infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Li, MD, PHD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
ShangHai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23918952
Citation
Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5.
Results Reference
derived

Learn more about this trial

Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer

We'll reach out to this number within 24 hrs