Dose Finding and Pharmacokinetics/Pharmacodynamics Study of Apatinib in the Treatment of Advanced Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT01531777|
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : April 3, 2015
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.
- Studying how well Apatinib works in treating patients.
- Finding the efficacy and safety of 500 mg or 750mg Apatinib.
- Exploring new outcome measures of antiangiogenic drugs.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Apatinib Drug: apatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Random, Open, Dose Finding and Pharmacokinetics/Pharmacodynamics(PK/PD) Phase II Study of Apatinib Tablets in the Treatment of Advanced Colorectal Cancer|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Experimental: Apatinib 500mg
500 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.
Experimental: Apatinib 750mg
750 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.
- ORR (Objective Response Rate) [ Time Frame: 12 weeks ]
- DCR (Disease Control Rate) [ Time Frame: 12 weeks after treatment ]
- PFS [ Time Frame: 3 years ]
- OS (Overall Survival) [ Time Frame: 3 years ]
- QoL (Quality of Life) [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531777
|Fudan University cancer hospital|
|Shanghai, Shanghai, China, 200000|
|Principal Investigator:||Jin Li, MD||Fudan University|