Apatinib in the Treatment of Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 and ≤ 80 years of age
- Histological confirmed advanced or metastatic colorectal cancer,at least one measurable lesion, larger than 10 mm in diameter by spiral CT
- Have failed for ≥ 2 lines of chemotherapy and/or targeted therapy
- Life expectancy of more than 3 months
- ECOG performance scale 0~1
- Duration from the last therapy is more than 4 weeks for operation, radiotherapy or cytotoxic agents
- Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 ×10^9/L, neutrophil > 1.5 × 10^9/L, serum creatinine ≤ 1×upper limit of normal(ULN), bilirubin < 1.5 ULN, and serum transaminase ≤ 2.0× 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:
- Prior VEGFR inhibitor treatment within 2 weeks
- History of other malignancies within 5 years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- 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
- Pregnant or lactating women
- Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- URT: urine protein ≥ (++)and > 1.0 g of 24 h
- PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation
- Certain possibility of gastric or intestine hemorrhage
Sites / Locations
- Department of General Surgery, Zhongshan Hospital, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
arm for Apatinib
Arm Description
500 mg,p.o.,qd
Outcomes
Primary Outcome Measures
PFS(progress free survival)
PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause
Secondary Outcome Measures
OS(overall survival)
OS is defined as the time from date of assignment to death due to any cause
ORR(objective response rate)
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
DCR(disease control rate)
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD)
Full Information
NCT ID
NCT03403452
First Posted
January 6, 2018
Last Updated
January 11, 2018
Sponsor
Fudan University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03403452
Brief Title
Apatinib in the Treatment of Metastatic Colorectal Cancer
Official Title
A Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed After Standard Second Line Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed after Standard Second Line Therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
arm for Apatinib
Arm Type
Experimental
Arm Description
500 mg,p.o.,qd
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
500 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.
Primary Outcome Measure Information:
Title
PFS(progress free survival)
Description
PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause
Time Frame
From assignment of the first subject to 3 months later after the last participant is recruited
Secondary Outcome Measure Information:
Title
OS(overall survival)
Description
OS is defined as the time from date of assignment to death due to any cause
Time Frame
From assignment of the first subject until 30 death events observed, up to 2 years
Title
ORR(objective response rate)
Description
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
Time Frame
From assignment of the first subject to 3 months later after the last participant is recruited
Title
DCR(disease control rate)
Description
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD)
Time Frame
From assignment of the first subject to 3 months later after the last participant is recruited
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 and ≤ 80 years of age
Histological confirmed advanced or metastatic colorectal cancer,at least one measurable lesion, larger than 10 mm in diameter by spiral CT
Have failed for ≥ 2 lines of chemotherapy and/or targeted therapy
Life expectancy of more than 3 months
ECOG performance scale 0~1
Duration from the last therapy is more than 4 weeks for operation, radiotherapy or cytotoxic agents
Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 ×10^9/L, neutrophil > 1.5 × 10^9/L, serum creatinine ≤ 1×upper limit of normal(ULN), bilirubin < 1.5 ULN, and serum transaminase ≤ 2.0× 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:
Prior VEGFR inhibitor treatment within 2 weeks
History of other malignancies within 5 years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
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
Pregnant or lactating women
Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
URT: urine protein ≥ (++)and > 1.0 g of 24 h
PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation
Certain possibility of gastric or intestine hemorrhage
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianmin Xu, PhD
Phone
+86-13501984869
Email
xujmin@aiiyun.com
Facility Information:
Facility Name
Department of General Surgery, Zhongshan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianmin xu, professor
Phone
008613501984869
Email
xujmin@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
qi lin, doctor
Phone
008615021519618
Email
lin777qi@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Apatinib in the Treatment of Metastatic Colorectal Cancer
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