A Study of Apatinib in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT01270386
Phase
PHASE2
Status
Completed

Conditions

  • Non-Small-Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • apatinib — DRUG
    Apatinib 750 mg p.o. once daily
  • placebo — DRUG
    placebo p.o. once daily

Study Details

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. 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 advanced non-squamous and non-small cell lung cancer who failed two lines of chemotherapy.

Key Dates

Start date
Mar 31, 2010
Status verified
Feb 2012
Primary completion
Jul 31, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
136 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib
    Apatinib 750 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
  • Placebo Comparator: Placebo
    Placebo qd p.o., and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Primary Outcome Measure

Progression free survival [ Time Frame: 8 weeks ]

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