UMIN-CTR Clinical Trial

Basic information
Public title	Phase II Trial of Apixaban in Japanese Patients with Cancer-Associated Venous Thromboembolism
Acronym	J-CAV study
Scientific Title	Phase II Trial of Apixaban in Japanese Patients with Cancer-Associated Venous Thromboembolism
Scientific Title:Acronym	J-CAV study
Region	Japan

Condition
Condition	cancer-associated venous thromboemborism (CA-VTE)
Classification by specialty	Cardiology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To verify the reproductivity of the safety and efficacy of apixaban for Japanese CA-VTE
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	incidence rate of the composite of major bleeding and clinically relevant non-major bleeding
Key secondary outcomes	1) incidence rate of the composite of recurrence of symptomatic VTE and VTE-related death 2) incidence rate of any bleeding 3) incidence rate of event-free survival (without VTE, major bleeding, and death) 4) duration of the hospitalizaion 5) colliration between Ottawa score and incidence rate of the composite of recurrence of symptomatic VTE and VTE-related death 6) colliration between Khorana score and incidence rate of the composite of recurrence of symptomatic VTE and VTE-related death

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Subjects will receive 10 mg b.i.d. apixaban for 7 days as an initial therapy, followed by 5 mg b.i.d. apixaban for 23 weeks as long-term therapy.
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) 20 years and older, both male and female 2) A diagnosis of cancer within six months before enrollment. Any treatment for cancer within the previous six months, or recurrent or metastatic cancer, or hematological malignancy without complete remission. 3) Objectively verified acute venous thrombosis 4) Informed consent
Key exclusion criteria	1) Hemodynamic instability 2) The patients will be treated with surgery or systemic thrombolysis for severe pulmonary embolism. Anticoagulant therapy prior to trial entry for > 7 days. 3) Subjects with an indication, other than VTE, intended for long-term anti-coagulant therapy, such as mechanical valve or arterial fibrillation 4) Use of a Factor Xa Inhibitor (e.g. apixaban, rivaroxaban, or edoxaban) =< 3 months prior to randomization 5) Thienopyridine therapy will be continued on study 6) Active bleeding or severe risk of bleeding 7) HIV protease inhibitor will be continued on study 8) Systemic use of Azole antifungals or Macrolide antibiotics at the time of registration 9) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 3 or 4 10) Life expectancy < 6 months 11) Laboratory data a) Platelet count < 50,000/mm^3 b) Calculated creatinine clearance < 30 ml/min using the Cockcroft-Gault formula c) AST or ALT > 3 x UNL d) PT-INR > 1.6 12) Clinically significant liver disease (e.g., acute hepatitis, chronic active hepatitis, or cirrhosis) 13) Severe hypersensitivity reaction to apixaban 14) Pregnant, breast-feeding, or unwilling to use adequate contraception 15) Other conditions inadequate for this research
Target sample size	62

Research contact person
Name of lead principal investigator	1st name Hironobu Middle name Last name Minami
Organization	Kobe University Hospital
Division name	Medical Oncology / Hematology
Zip code	650-0017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-5820
Email	hminami@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Yoshinori Middle name Last name Imamura
Organization	Kobe University Hospital
Division name	Medical Oncology / Hematology
Zip code	650-0017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-5820
Homepage URL
Email	yimamura@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Hospital, Medical Oncology / Hematology
Institute
Department

Funding Source
Organization	Kobe University Hospital, Medical Oncology / Hematology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University Hospital Clinical & Translational Research Center
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel	078-382-6669
Email	kainyu@med.kobe-u.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	神戸大学医学部附属病院（兵庫県）、近畿大学医学部附属病院（大阪府）、大阪市立大学附属病院（大阪府）、神戸低侵襲がん医療センター（兵庫県）

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 01 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	Terminated
Date of protocol fixation	2018 Year 01 Month 24 Day
Date of IRB	2018 Year 01 Month 29 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2019 Year 08 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 31 Day
Last modified on	2022 Year 06 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032563