UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009579 |
|---|---|
| Receipt number | R000011240 |
| Scientific Title | Phase II study of personalized titration of axitinib using therapeutic drug monitoring (TDM) in sunitinib-refractory metastatic or advanced renal cell carcinoma |
| Date of disclosure of the study information | 2012/12/19 |
| Last modified on | 2018/09/27 16:45:09 |
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Basic information
Public title
Phase II study of personalized titration of axitinib using therapeutic drug monitoring (TDM) in sunitinib-refractory metastatic or advanced renal cell carcinoma
Acronym
Phase II study of personalized titration of axitinib using TDM in sunitinib-refractory renal cell carcinoma
Scientific Title
Phase II study of personalized titration of axitinib using therapeutic drug monitoring (TDM) in sunitinib-refractory metastatic or advanced renal cell carcinoma
Scientific Title:Acronym
Phase II study of personalized titration of axitinib using TDM in sunitinib-refractory renal cell carcinoma
Region
| Japan |
Condition
Condition
Renal cell carcinoma
Classification by specialty
| Hematology and clinical oncology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1. To evaluate the efficacy of personalized titration of axitinib using Therapeutic Drug Monitoring (TDM) in sunitinib-refractory metastatic or advanced renal cell carcinoma.
2. To determine the cutoff of Area Under the Curve (AUC) to predict the efficacy of axitinib.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival rate at 6 months
Key secondary outcomes
Pharmacokinetics, response rate, time to treatment failure, safety
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
Titration of axitinib using Therapeutic Drug Monitoring (TDM)
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) Patients with metastatic or advanced renal cell carcinoma with histological confirmation of clear cell carcinoma or a component of clear cell.
2) Patients must have received one prior therapy with sunitinib and had disease progression on or within 6 months of stopping sunitinib therapy. (Prior cytokines therapy is permitted.)
3) Aged >= 20
4) ECOG performance status 0-1.
5) Patients with evaluable disease as defined by the RECIST criteria.
6) Patients with adequate bone marrow reserve (neutrophil count >=1500/mm3, hemoglobin level >= 9.0 g/dL, platelet count >= 75,000/mm3), adequate liver function (AST and ALT <= 100 IU/L, total bilirubin <= 2.0 mg/dL), kidney function (serum creatinine <=2.0 mg/dL. All laboratory data should be evaluated within 14 days before enrollment.
7) Expected survival >= 90 days.
8) Written informed consent obtained from patients.
Key exclusion criteria
1) Patients who received VEGFR inhibitors (sorafenib, axitinib etc.) except for sunitinib, anti-VEGF antibody (bevacizumab), or mTOR inhibitors (everolimus or temsirolimus).
2) Patients who received palliative radiotherapy for bone metastasis within 2 weeks.
3) Patients who received major surgery within 4 weeks.
4) Patients who do not recover from side effects of sunitinib.
5) Patients with symptomatic brain metastases.
6) Patients with other active malignancies.
7) Patients with active infections.
8) Patients with serious complications (uncontrollable gastrointestinal bleeding, diabetics, cardiac diseases and hypertension etc.).
9) Patients who are undergoing dialysis.
10) Patients who developed pulmonary embolism, myocardial infarction, congestive heart failure and cerebrovascular disease within 12 months.
11) Patients with a history of serious drug allergy.
12) Patients who receive continuous corticosteroid administration.
13) Patients with serious mental problem.
14) Pregnant or lactating female.
15) Other patients evaluated to be inadequate to participate in this study by investigators.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshimi Takano |
Organization
Toranomon Hospital
Division name
Department of Medical Oncology
Zip code
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
takano@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Miura |
Organization
Toranomon Hospital
Division name
Department of Medical Oncology
Zip code
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
Homepage URL
yujmiura@mac.com
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Research Foundation for Clinical Pharmacology
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2012 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 19 | Day |
Last modified on
| 2018 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011240
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