UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031235 |
|---|---|
| Receipt number | R000035665 |
| Scientific Title | Clinical Analysis of drug inTEraction between CatecHin and Ixazomib for patieNts with multiple myeloma |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2023/12/28 12:36:24 |
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Basic information
Public title
Clinical Analysis of drug inTEraction between CatecHin and Ixazomib for patieNts with multiple myeloma
Acronym
CATECHIN study
Scientific Title
Clinical Analysis of drug inTEraction between CatecHin and Ixazomib for patieNts with multiple myeloma
Scientific Title:Acronym
CATECHIN study
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To examine pharmacokinetics of ixazomib with green tea in Japanese patients with relapse/refractory multiple myeloma.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PK parameters of Ixazomib
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Water
Interventions/Control_2
Green tea
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. Age >20 years old
2. Performance status 0, 1 or 2
3. Patients with relapse/refractory multiple myeloma or plasmacytoma
4. laboratory data
Neutrophil >1000/microL
Platelet >75000/microL
T-Bil <2.25 mg/mL
CCr >30 mL/min
5. Expected more than 6 months survival
Key exclusion criteria
1. Using other anticancer drugs
2. Systemic surgery within 14 days
3. active infections
4. CNS involvement
5. uncontrolable cardiovascular disease
6. active HBV, HCV, or HIV
7. severe complications
8. difficulty in swallowing
9. mental diseases
10. allergic to study drugs
11. pregnant or Brest feeding
12. strong CYP1A2 inhibitor, strong CYP3A inhibitor, CYP3A inducer
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Minami |
Organization
Kobe University Hospital
Division name
Department of Medical Oncology and Hematology
Zip code
650-0017
Address
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe city
TEL
078-382-5820
hminami@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihito |
| Middle name | |
| Last name | Kitao |
Organization
Kobe University Hospital
Division name
Department of Medical Oncology and Hematology
Zip code
650-0017
Address
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe city
TEL
078-382-5820
Homepage URL
akitao@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board, Kobe University Hospital
Address
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe city
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | 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 | 02 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 09 | Day |
Last modified on
| 2023 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035665
