Dose Finding and Pharmacokinetics/Pharmacodynamics Study of Apatinib Tablets in the Treatment of Advanced Colorectal Cancer
This study is currently recruiting participants.
Verified February 2012 by Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
First received: February 7, 2012
Last updated: February 10, 2012
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 efficiency 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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||July 2012 (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
|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 × 109/L, neutrophil > 1.5 × 109/L, serum creatinine ≤ 1X 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531777
|Fudan University cancer hospital
|Shanghai, Shanghai, China, 200000 |
|Contact: JIN LI, MD +86-21-64175590 email@example.com |
|Principal Investigator: JIN LI, MD |
Jiangsu HengRui Medicine Co., Ltd.
||JIN LI, MD
No publications provided
||Jiangsu HengRui Medicine Co., Ltd.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 7, 2012
||February 10, 2012
||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 May 16, 2013
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases