UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028447 |
|---|---|
| Receipt number | R000032563 |
| Scientific Title | Phase II Trial of Apixaban in Japanese Patients with Cancer-Associated Venous Thromboembolism |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2022/06/07 20:49:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yimamura@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital, Medical Oncology / Hematology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032563
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
