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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027209
Receipt No. R000031174
Scientific Title Phase I/II clinical trial of verification for the safety and efficacy of Amitose-Bis-glyceryl ascorbate-containing cream in renal cell carcinoma patients treated by sunitinib
Date of disclosure of the study information 2018/12/27
Last modified on 2018/12/27

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Basic information
Public title Phase I/II clinical trial of verification for the safety and efficacy of Amitose-Bis-glyceryl ascorbate-containing cream in renal cell carcinoma patients treated by sunitinib
Acronym Phase I/II clinical trial of verification for the safety and efficacy of Amitose-Bis-glyceryl ascorbate-containing cream in renal cell carcinoma patients treated by sunitinib
Scientific Title Phase I/II clinical trial of verification for the safety and efficacy of Amitose-Bis-glyceryl ascorbate-containing cream in renal cell carcinoma patients treated by sunitinib
Scientific Title:Acronym Phase I/II clinical trial of verification for the safety and efficacy of Amitose-Bis-glyceryl ascorbate-containing cream in renal cell carcinoma patients treated by sunitinib
Region
Japan

Condition
Condition Renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of bis-glyceryl ascorbate-containing cream for hand-foot skin reaction in renal cell carcinoma patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phase I: Cutaneous abnormality including erythem, edema, papula, and vesicle
Phase II: Incidence of HFSR of grade 1 of higher within 6 weeks after initiation of sunitinib treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Patients are applied Amitose-bis-glyceryl ascorbate to palmar and planter region three times or higher a day with concomitant administration of 10% urea or heparinoid-containing cream.
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 who give informed consent and who are 20 years of age at least
2) Patients who were diagnosed renal cell carcinoma
3) Patients who recieve sunitinib treatment including previously treatment of targeted therapy and neoadjuvant therapy
4) ECOG PS: 0-2
5) Patients who are expected to survive at least 12 weeks
6) Patients who observe the protocol compliance
Key exclusion criteria 1) Patients in whom the underlying disease is a dermatological disease at palmar and planter region at initiation of sunitinib treatment
2) Patients who are applied external medicine not involving 10% urea and heparinoid-containing cream to palmar and planter region at initiation of sunitinib treatment
3) Patients who are not able to apply 10% urea or heparinoid-containing cream to palmar and planter region
4) Patients with HFSR of grade 1 or higher at initiation of sunitinib treatment
5) Patients with infections which needs systemic treatment
6) Patients with severe hepatic disorder
7) Patients with severe renal disorder
8) Patients who are lack of felicity
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chikako Nishigori
Organization Kobe University Hospital
Division name Dermatology
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-6641
Email chikako@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kauhiro Yamamoto
Organization Kobe University Hospital
Division name Pharmacy
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-6659
Homepage URL
Email yamakz@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
Institute
Department

Funding Source
Organization Momotani Juntenkan LTD.
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

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 27 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 22 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
2017 Year 05 Month 01 Day
Last modified on
2018 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031174

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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