UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031359 |
|---|---|
| Receipt number | R000035723 |
| Scientific Title | A PK/PD study of Ixazomib in Japanese mutiple myeloma patients with renal or hepatic impairment |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2022/06/10 10:17:07 |
* 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
A PK/PD study of Ixazomib in Japanese mutiple myeloma patients with renal or hepatic impairment
Acronym
Ixazomib_renal/hepatic failure_PK/PD
Scientific Title
A PK/PD study of Ixazomib in Japanese mutiple myeloma patients with renal or hepatic impairment
Scientific Title:Acronym
Ixazomib_renal/hepatic failure_PK/PD
Region
| Japan |
Condition
Condition
Relapsed and/or Refractory Multiple Myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate appropriate Ixazomib dose when IRD therapy is administered to Relapsed and/or Refractory Multiple Myeloma patients with severe renal impairment and moderate or severe liver impairment,
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The AUC of the severe renal impairment cohort
Key secondary outcomes
The PK(Cmax, Tmax) of the severe renal impairment cohort
Overall response rate at 24 weeks from the start of study treatment [renal impairment cohort]
Overall survival rate at 24 weeks from the start of study treatment [renal impairment cohort]
Adverse events and serious adverse events from the start of the study treatment up to 24 weeks.[renal impairment cohort]
The PK (AUC, Cmax, Tmax) of the severe hepatic impairment cohort
Overall response rate at 24 weeks from the start of study treatment [hepatic impairment cohort]
Overall survival rate at 24 weeks from the start of study treatment [hepatic impairment cohort]
Adverse events and serious adverse events from the start of the study treatment up to 24 weeks [hepatic impairment cohort]
Overall survival rate at 52 weeks from the start of study treatment [renal impairment cohort, hepatic impairment cohort]
PPK parameters of Ixazomib [renal impairment cohort, hepatic impairment cohort]
PK parameters of Lenalidomide [renal impairment cohort, hepatic impairment cohort]
PPK parameters of Lenalidomide [renal impairment cohort, hepatic impairment cohort]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ixazomib(4mg) + Lenalidomide + Dexamethasone
Interventions/Control_2
Ixazomib(3mg) + Lenalidomide + Dexamethasone
Interventions/Control_3
Ixazomib(3mg) + Lenalidomide + Dexamethasone
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)Men and women of age 20 years or older at the consent acquisition date
(2)Performance status of 0-2 according to the Eastern Cooperative Oncology Group (ECOG) scale.
(3)Patients with RRMM
(4) The latest inspection value within 14 days before registration meets all of the following. The evaluation of CCr and T-Bil is different
Two bleeds (that is not possible on the same date) will be subject to both criteria.
[Renal disorder cohort]
1. Number of neutrophils >= 1,000/uL
2. Platelet count >= 75,000 / uL
3. AST <= 90 U / L: 3 times or less than normal upper limit value
4. ALT <=126 U / L (male) or 69 U / L (female): 3 times or less of normal upper limit
5. T-Bil <= 2.25 mg / mL: 1.5 times or less of normal upper limit value
6. CCr <= 30 mL / min
[Liver disorder cohort]
1. Number of neutrophils >= 1,000 / uL
2. Platelet count >= 75,000 / uL
3. T-Bil> 2.25 mg / mL: exceeds 1.5 normal upper limit
4. CCr> 30 mL / min
(6) Survival of more than 6 months can be expected from the date of registration.
(7) With regard to participation in this examination, document consent was obtained by the volunteer's free will.
Key exclusion criteria
(1) Patients with another active malignancy
(2) Patients who underwent surgical operations requiring general anesthesia within 14 days before registration
(3) have active infection requiring systemic treatment.
(4) has central invasive lesion of multiple myeloma / plasmacytoma.
(5) have poorly controlled cardiovascular disease (hypertension, arrhythmia, heart failure, unstable angina or myocardial infarction that developed within 6 months before enrollment).
(6) Active HBV infection (Hbs antigen positive and HBV-DNA positive) and HCV infection (HCV antibody positive and HCV-RNA positive), or known HIV infection.
(7) Severe complications (active gastrointestinal ulcer, intestinal palsy, intestinal obstruction, inflammatory bowel disease, interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes etc.).
(8) Patients whose mental illness or psychiatric symptoms, which interferes with daily life, are merged and judged to be difficult to participate in the examination.
(9) Patients who are considered difficult to participate in the exam because of complicated with psychiatric disorders or psychiatric symptoms that interfere with daily living
(10) Patients who are hypersensitive to test drugs and their analogs and additivesients whose oral medications are difficult to administer or whose administration conditions can not be observed or whose undergoing gastrointestinal procedures that affect oral drug absorption and tolerability.
(11) pregnant women,Lactating women,or a woman with the possibility (or intention). of a pregnant.
(12) patients undergoing systemic administration of strong CYP1A2 inhibitors (fluvoxamine, ciprofloxacin), potent CYP3A inhibitors (clarithromycin, itraconazole, voriconazole), potent CYP3A inducers (rifampicin, rifabutin, carbamazepine, Phenytoin, Phenobarbital), ginkgo biloba or St. John's Wort.
(13) Patients who are judged inappropriate as subjects of this study by an investigator or a test sharing doctor.
Target sample size
17
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 | Akihito |
| Middle name | |
| Last name | Kitao |
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
akitao@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
Ethical Review Board, Kobe University Hospital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel
078-382-6669
chiken@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 | 19 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 16 | 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 | 19 | Day |
Last modified on
| 2022 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035723
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
