UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011147 |
|---|---|
| Receipt number | R000013054 |
| Scientific Title | The exploratory study to determine optimum dosing of Axitinib (tyrosine kinase inhibitor) with pharmacokinetic analysis for patients with metastatic renal cell carcinoma |
| Date of disclosure of the study information | 2013/07/10 |
| Last modified on | 2013/07/08 22:00:32 |
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Basic information
Public title
The exploratory study to determine optimum dosing of Axitinib (tyrosine kinase inhibitor) with pharmacokinetic analysis for patients with metastatic renal cell carcinoma
Acronym
The study to determine optimum dosing of Axitinib for patients with metastatic renal cell carcinoma
Scientific Title
The exploratory study to determine optimum dosing of Axitinib (tyrosine kinase inhibitor) with pharmacokinetic analysis for patients with metastatic renal cell carcinoma
Scientific Title:Acronym
The study to determine optimum dosing of Axitinib for patients with metastatic renal cell carcinoma
Region
| Japan |
Condition
Condition
metastatic renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of the study is to investigate the relationship between the blood concentration of Axitinib and the dosage amount, and to evaluate the association with clinical efficacy/adverse event and blood level in patients with metastatic renal cell carcinoma. Additionally, we have investigated the impact of the selected single nucleotide polymorphisms in CYP3A4 and UGT1A genes on the pharmacokinetics of Axitinib in the patients.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between the blood concentration of Axitinib and the dosage amount, and to evaluate the association with clinical efficacy/adverse event and blood level.
Key secondary outcomes
The impact of the selected single nucleotide polymorphisms in CYP3A4 and UGT1A genes on the pharmacokinetics of Axitinib.
The formulation of model that predict clinical effect and adverse event.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We discriminate slow metabolizer or rapid metabolizer of Axitinib after we analyze the 15 cases,. On the basis of date, we escalate the dose of Axitinib in next 5 patients.
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
metastatic rena cell carcinoma
Key exclusion criteria
1) ECOG PS>1
2) sBP>150mmHg or dBP>100mmHg
3) Hb<9.0g/dl
4) neutrophil count<1000/mm3
5) pletelet count<75000/mm3
6) AST/ALT>2.5 ULN
7) total bilirubin>1.5 ULN
8) urine protein>2+ and 2g/day
9) sCre>1.5 ULN
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyasu Matsuyama |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Urology
Zip code
Address
Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Urology
Zip code
Address
TEL
Homepage URL
ykawai@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Urology, Graduate School of Medicine, Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Graduate School of Medicine, Yamaguchi University
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
Address
Tel
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
| 2013 | Year | 07 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 08 | Day |
Last modified on
| 2013 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013054
