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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043850
Receipt No. R000049919
Scientific Title Evaluation for the safety of a novel oral Xa inhibitor in combination with chemotherapy in patients with advanced or recurrent colorectal cancer
Date of disclosure of the study information 2021/04/06
Last modified on 2021/04/06

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Basic information
Public title Evaluation for the safety of a novel oral Xa inhibitor in combination with chemotherapy in patients with advanced or recurrent colorectal cancer
Acronym Evaluation for the safety of a novel oral Xa inhibitor in combination with chemotherapy in patients with advanced or recurrent colorectal cancer
Scientific Title Evaluation for the safety of a novel oral Xa inhibitor in combination with chemotherapy in patients with advanced or recurrent colorectal cancer
Scientific Title:Acronym Evaluation for the safety of a novel oral Xa inhibitor in combination with chemotherapy in patients with advanced or recurrent colorectal cancer
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We will investigate the drug interaction (anti-Xa activity) between edoxaban, which is used for the treatment of venous thromboembolism (VTE) and prevention of recurrence, or for the prevention of stroke and systemic embolism in patients with atrial fibrillation, and anticancer drugs used in the treatment of colorectal cancer, and the safety of the combination.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Anti-Xa activity in the blood during chemotherapy for colorectal cancer
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients undergoing or scheduled to undergo chemotherapy for advanced or recurrent colorectal cancer
2) Patients diagnosed with deep vein thrombosis (DVT) by lower limb vein echography (symptomatic or asymptomatic) or pulmonary artery thromboembolism (PTE) by chest contrast CT scan (symptomatic or asymptomatic) who are already taking edoxaban.
3) Patients with paroxysmal atrial fibrillation who are already taking edoxaban to prevent stroke or systemic embolism.
4) Patients aged 20 years or older
(5) Performance status (PS: index of patient's general condition) is 0 to 2 according to ECOG criteria.
(6) Patients who can obtain written consent from the patient.
(2) and (3) are either satisfied.
Key exclusion criteria (1) Patients who are bleeding
(2) Patients with complications that may cause bleeding
3) Patients using heparin, low molecular weight heparin, danaparoid, antithrombin (argatroban, etc.), oral anticoagulant (warfarin), thrombolytic, antiplatelet agents (ticlopidine, clopidogrel, aspirin, etc.)
Patients who are taking strong inducers or inhibitors of CYP3A4.
(5) Patients who do not have major organ function.
Patients who do not meet any of the following criteria
(6) Patients with a known history of hypersensitivity to any component of the study drug or any drug used in the chemotherapy regimen
(7) Patients with a history of cerebral hemorrhage
(viii) Patients with contrast media allergy
(9) Patients with acute bacterial endocarditis
(10) Patients for whom edoxaban cannot be administered according to the package insert
(11) Other patients deemed inappropriate for the study by the principal investigator or sub-investigator.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masataka
Middle name
Last name Ikeda
Organization Hyogo College of Medicine
Division name Division of lower GI, department of surgery
Zip code 663-8501
Address 1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL 0798-45-6372
Email ms-ikeda@hyo-med.ac.jp

Public contact
Name of contact person
1st name Jihyung
Middle name
Last name Song
Organization Hyogo College of Medicine
Division name Division of lower GI, department of surgery
Zip code 663-8501
Address 1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL 0798-45-6372
Homepage URL
Email ch-son@hyo-med.ac.jp

Sponsor
Institute Division of lower GI, department of surgery, Hyogo College of Medicine
Institute
Department

Funding Source
Organization DAIICHI SANKYO COMPANY
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka International Cancer Institute
Kansai Rosai Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hyogo College of Medicine
Address 1-1 Mukogawa, Nishinomiya, Hyogo, Japan
Tel 0798-45-6066
Email rinri@hyo-med.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2020 Year 12 Month 08 Day
Date of IRB
2021 Year 01 Month 21 Day
Anticipated trial start date
2021 Year 04 Month 06 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A prospective non-interventional observational study

Management information
Registered date
2021 Year 04 Month 06 Day
Last modified on
2021 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049919

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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