Apatinib in the Treatment of Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed After Standard Second Line Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03403452
• Other study ID #: APAMCRC
• Status: Recruiting
• Phase: Phase 2
• First received: January 6, 2018
• Last updated: January 11, 2018
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2018
• Source: Fudan University
• Contact: Jianmin Xu, PhD
• Phone: +86-13501984869
• Email: xujmin[@]aiiyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Department of General Surgery, Zhongshan Hospital, Fudan University	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS(progress free survival)	PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause	From assignment of the first subject to 3 months later after the last participant is recruited
Secondary	OS(overall survival)	OS is defined as the time from date of assignment to death due to any cause	From assignment of the first subject until 30 death events observed, up to 2 years
Secondary	ORR(objective response rate)	The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)	From assignment of the first subject to 3 months later after the last participant is recruited
Secondary	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)	From assignment of the first subject to 3 months later after the last participant is recruited