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

This study has been completed.
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00970138
First received: September 1, 2009
Last updated: July 11, 2011
Last verified: September 2010
  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 compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.


Condition Intervention Phase
Gastric Carcinoma
Drug: apatinib tablet
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Phase 2/3 Study of Apatinib as Third Line Treatment in Patients With Metastatic Gastric Carcinoma

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival safety [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • DCR (Disease control rate) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • ORR (Objective response rate) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • QoL (Quality of life) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Toxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 141
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 850
apatinib 850 mg qd, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: apatinib tablet

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

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

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

Placebo Comparator: C pla
placebo bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: apatinib tablet

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


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.

  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
  • 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.
  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: NCT00970138

Locations
China, Shanghai
Fudan University Cancer Hospital
ShangHai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jin Li, MD, PHD Fudan University
  More Information

No publications provided by Fudan University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jin Li/Dr, Fudan University cancer hospital
ClinicalTrials.gov Identifier: NCT00970138     History of Changes
Other Study ID Numbers: 2009APA-MGC
Study First Received: September 1, 2009
Last Updated: July 11, 2011
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Progress free survival
Toxicity
Response rate
Overall survival
Quality of live

Additional relevant MeSH terms:
Carcinoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on August 28, 2014