Dose Finding and Pharmacokinetics/Pharmacodynamics Study of Apatinib in the Treatment of Advanced Colorectal Cancer
This study has been completed.
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
First received: February 7, 2012
Last updated: April 2, 2015
Last verified: February 2012
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Random, Open, Dose Finding and Pharmacokinetics/Pharmacodynamics(PK/PD) Phase II Study of Apatinib Tablets in the Treatment of Advanced Colorectal Cancer
Primary Outcome Measures:
- ORR (Objective Response Rate) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- DCR (Disease Control Rate) [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
- PFS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- OS (Overall Survival) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- QoL (Quality of Life) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 70 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- ≥ 18 and ≤ 70 years of age
- Histological confirmed advanced or metastatic colorectal Cancer，at least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )
- Have failed for ≥ 2 lines of chemotherapy
- Life expectancy of more than 3 months
- ECOG performance scale ≤ 1
- Duration from the last therapy is more than 6 weeks for nitroso or mitomycin More than 4 weeks for operation, radiotherapy or cytotoxic agents
- Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 × 10E+9/L, neutrophil > 1.5 × 10E+9/L, serum creatinine ≤ 1×upper limit of normal(ULN), bilirubin < 1.25 ULN, and serum transaminase ≤ 2.5× ULN)
- Child bearing potential, a negative urine or serum pregnancy test result before initiating apatinib, must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article.
- Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Pregnant or lactating women
- Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy, more than class I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia(including QTcF:male ≥ 450 ms, female ≥ 470 ms), or cardiac insufficiency myocardial ischemia, arrhythmia, or cardiac insufficiency
- Before or at the same time any, second 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
- URT: urine protein ≥ (++)and > 1.0 g of 24 h
- PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation
- Abuse of drugs
- Certain possibility of gastric or intestine hemorrhage
- Less than 4 weeks from the last clinical trial
- Viral hepatitis type B or type C
- Prior VEGFR inhibitor treatment
- Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01531777
|Fudan University cancer hospital
|Shanghai, Shanghai, China, 200000 |
Jiangsu HengRui Medicine Co., Ltd.
||Jin Li, MD
||Jiangsu HengRui Medicine Co., Ltd.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 7, 2012
||April 2, 2015
||China: Food and Drug Administration
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Advanced Colorectal Cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 28, 2016
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases