Dose Finding and Pharmacokinetics/Pharmacodynamics Study of Apatinib in the Treatment of Advanced Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|