UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006579 |
|---|---|
| Receipt number | R000007789 |
| Scientific Title | Sunitinib treatment of unresectable malignant pheochromocytoma and paraganglioma |
| Date of disclosure of the study information | 2011/10/20 |
| Last modified on | 2018/05/01 19:09:58 |
* 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
Sunitinib treatment of unresectable malignant pheochromocytoma and paraganglioma
Acronym
Sunitinib treatment of unresectable malignant pheochromocytoma and paraganglioma
Scientific Title
Sunitinib treatment of unresectable malignant pheochromocytoma and paraganglioma
Scientific Title:Acronym
Sunitinib treatment of unresectable malignant pheochromocytoma and paraganglioma
Region
| Japan |
Condition
Condition
malignant pheochromocytoma
malignant paraganglioma
Classification by specialty
| Endocrinology and Metabolism | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of sunitinib in the treatment of unresectable malignant pheochromocytoma and paraganglioma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event/Side effect
Disease control rate
Key secondary outcomes
Time to treatment failure
Response Rate
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
Sunitinib
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed with malignant
pheochromcytoma or paraganglioma
2) ECOG performance status; 0-2
3) Unresectable
4) Age; 20-755
5) neutrophil below 1,500/uL
Hb below 8.5g/dL
PLT below 100,000/uL
AST(GOT) above 65IU/L
ALT(GPT) above 210IU/L
Ejection Fraction below 50%
Serum Cre above 1.5mg/dL
6) Informed consent; Agreement by a
document
Key exclusion criteria
1) Brain metastasis
2) Existence of other malignancy before registration for less than 5 years.
3) Treatment history with other tyrosine kinase inhibitors or anti-angiogenic drugs.
4) Severe liver dysfunction; Child-Pugh classification C
5) History of previous hypersensitivity for an ingredient of sutent.
6) The women who has possibility of or hopes for the pregnancy.Breast-feeding mother. The men who hopes for the pregnancy of a partner.
7) Difficulty in participating to an study due to psychiatric disorders.
8) The case that Chief Researcher or doctor judge as unsuitable for enrollment.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ogawa Osamu |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
Syogoinkawahara-cho 54, Sakyo-u, Kyoto
TEL
075-751-3700
ogawao@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamasaki Toshinari |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
Syogoinkawahara-cho 54, Sakyo-u, Kyoto
TEL
075-751-3700
Homepage URL
yamatosi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Urology, Kyoto University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Pfizer inc
Organization
Division
Category of Funding Organization
Profit organization
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
京都大学医学部附属病院（京都府） Kyoto University Hospital (Kyoto)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 20 | 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
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | 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
| 2011 | Year | 10 | Month | 20 | Day |
Last modified on
| 2018 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007789
