Apatinib in the Treatment of Metastatic Colorectal Cancer

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

This is an Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed after Standard Second Line Therapy.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Apatinib

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jianmin Xu, PhD; Phone Number: +86-13501984869; Email: xujmin@aiiyun.com

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Department of General Surgery, Zhongshan Hospital, Fudan University
    • Contact: jianmin xu, professor; Phone Number: 008613501984869; Email: xujmin@yahoo.com.cn
    • Contact: qi lin, doctor; Phone Number: 008615021519618; Email: lin777qi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: arm for Apatinib; 500 mg,p.o.,qd	Drug: Apatinib; 500 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	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: January 6, 2018
• First Submitted That Met QC Criteria: January 11, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• 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: APAMCRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No