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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

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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

xujmin@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

qi lin, doctor

Phone

008615021519618

lin777qi@163.com

12. IPD Sharing Statement

Plan to Share IPD

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Apatinib in the Treatment of Metastatic Colorectal Cancer

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