- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01531777
Dose Finding and Pharmacokinetics/Pharmacodynamics Study of Apatinib in the Treatment of Advanced Colorectal Cancer
April 2, 2015 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Random, Open, Dose Finding and Pharmacokinetics/Pharmacodynamics(PK/PD) Phase II Study of Apatinib Tablets in the Treatment of Advanced Colorectal Cancer
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:
- Studying how well Apatinib works in treating patients.
- Finding the efficacy and safety of 500 mg or 750mg Apatinib.
- Pharmacokinetics/Pharmacodynamics(PK/PD).
- Exploring new outcome measures of antiangiogenic drugs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200000
- Fudan University Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ≥ 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Apatinib 500mg
500mg,p.o.,qd
|
500 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.
|
Experimental: Apatinib 750mg
750mg,p.o.,qd
|
750 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ORR (Objective Response Rate)
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PFS
Time Frame: 3 years
|
3 years
|
DCR (Disease Control Rate)
Time Frame: 12 weeks after treatment
|
12 weeks after treatment
|
OS (Overall Survival)
Time Frame: 3 years
|
3 years
|
QoL (Quality of Life)
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jin Li, MD, Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
February 7, 2012
First Submitted That Met QC Criteria
February 10, 2012
First Posted (Estimate)
February 13, 2012
Study Record Updates
Last Update Posted (Estimate)
April 3, 2015
Last Update Submitted That Met QC Criteria
April 2, 2015
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Apatinib
Other Study ID Numbers
- APTN-II-CRC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
Wuhan Union Hospital, ChinaWithdrawnColorectal Cancer | Chemotherapy | Angiogenesis
-
Tianjin Medical University Second HospitalJiangsu HengRui Medicine Co., Ltd.Unknown
-
Huazhong University of Science and TechnologyUnknown
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Ruijin HospitalActive, not recruitingGastric and Gastroesophageal Junction (GEJ) AdenocarcinomaChina