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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name