NCT00970138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 12, 2011

Status Verified

September 1, 2010

Enrollment Period

1.3 years

First QC Date

September 1, 2009

Last Update Submit

July 11, 2011

Conditions

Gastric Carcinoma

Keywords

Progress free survivalToxicityResponse rateOverall survivalQuality of live

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    8 weeks

Secondary Outcomes (5)

  • Overall survival safety

    8 weeks

  • DCR (Disease control rate)

    8 weeks

  • ORR (Objective response rate)

    8 weeks

  • QoL (Quality of life)

    8 weeks

  • Toxicity

    8 weeks

Study Arms (3)

A 850

EXPERIMENTAL

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

Drug: apatinib tablet

B 425

EXPERIMENTAL

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

Drug: apatinib tablet

C pla

PLACEBO COMPARATOR

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

Drug: apatinib tablet

Interventions

apatinib tabletDRUG

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

A 850B 425C pla

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • 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.

    PMID: 23918952DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Jin Li, MD, PHD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 2, 2009

Study Start

June 1, 2009

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

July 12, 2011

Record last verified: 2010-09

Locations

CN(1)