Apatinib in the Treatment of Metastatic Colorectal Cancer

NCT03403452 | Unknown Phase 2

• 1 other identifier: APAMCRC
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• OS（overall survival）

  From assignment of the first subject until 30 death events observed, up to 2 years

• ORR（objective response rate）

  From assignment of the first subject to 3 months later after the last participant is recruited

• DCR（disease control rate)

  From assignment of the first subject to 3 months later after the last participant is recruited

Study Arms (1)

arm for Apatinib

EXPERIMENTAL

500 mg,p.o.,qd

Drug: Apatinib

Interventions

Apatinib DRUG

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

arm for Apatinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Department of General Surgery, Zhongshan Hospital, Fudan University

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Jianmin Xu, PhD

CONTACT

+86-13501984869; xujmin@aiiyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of colorectal surgery

Study Record Dates

• First Submitted: January 6, 2018
• First Posted: January 18, 2018
• Study Start: January 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)