Dose Finding and Pharmacokinetics/Pharmacodynamics Study of Apatinib in the Treatment of Advanced Colorectal Cancer

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT01531777
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Apatinib — DRUG
    500 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.
  • apatinib — DRUG
    750 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.

Study Details

RATIONALE: 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. PURPOSE: 1. Studying how well Apatinib works in treating patients. 2. Finding the efficacy and safety of 500 mg or 750mg Apatinib. 3. Pharmacokinetics/Pharmacodynamics(PK/PD). 4. Exploring new outcome measures of antiangiogenic drugs.

Key Dates

Start date
Apr 30, 2011
Status verified
Feb 2012
Primary completion
Nov 30, 2014
Completion
Nov 30, 2014

Study Design

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

Arms

  • Experimental: Apatinib 500mg
    500mg,p.o.,qd
  • Experimental: Apatinib 750mg
    750mg,p.o.,qd

Primary Outcome Measure

ORR (Objective Response Rate) [ Time Frame: 12 weeks ]

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