Apatinib in the Treatment of Metastatic Colorectal Cancer

NCT ID: NCT03403452

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-12-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

arm for Apatinib

500 mg,p.o.,qd

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

500 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.

Interventions

Apatinib

500 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xu jianmin

Director of colorectal surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of General Surgery, Zhongshan Hospital, Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianmin Xu, PhD

Role: CONTACT

xujmin@aiiyun.com

+86-13501984869

Facility Contacts

jianmin xu, professor

Role: primary

xujmin@yahoo.com.cn

008613501984869

qi lin, doctor

Role: backup

lin777qi@163.com

008615021519618

Other Identifiers

APAMCRC

Identifier Type: -

Identifier Source: org_study_id