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Apatinib in the Treatment of Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03403452
Recruitment Status : Unknown
Verified January 2018 by Xu jianmin, Fudan University.
Recruitment status was:  Recruiting
First Posted : January 18, 2018
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Xu jianmin, Fudan University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Apatinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed After Standard Second Line Therapy
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. PFS（progress free survival） [ Time Frame: From assignment of the first subject to 3 months later after the last participant is recruited ]
    PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause


Secondary Outcome Measures :
  1. OS（overall survival） [ Time Frame: From assignment of the first subject until 30 death events observed, up to 2 years ]
    OS is defined as the time from date of assignment to death due to any cause

  2. ORR（objective response rate） [ Time Frame: From assignment of the first subject to 3 months later after the last participant is recruited ]
    The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)

  3. DCR（disease control rate) [ Time Frame: From assignment of the first subject to 3 months later after the last participant is recruited ]
    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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403452


Contacts
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Contact: Jianmin Xu, PhD +86-13501984869 xujmin@aiiyun.com

Locations
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China
Department of General Surgery, Zhongshan Hospital, Fudan University Recruiting
Shanghai, China, 200032
Contact: jianmin xu, professor    008613501984869    xujmin@yahoo.com.cn   
Contact: qi lin, doctor    008615021519618    lin777qi@163.com   
Sponsors and Collaborators
Fudan University
Jiangsu HengRui Medicine Co., Ltd.
More Information
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Responsible Party: Xu jianmin, Director of colorectal surgery, Fudan University
ClinicalTrials.gov Identifier: NCT03403452    
Other Study ID Numbers: APAMCRC
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action