UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027209 |
|---|---|
| Receipt number | 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 | 2022/05/06 09:03:34 |
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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 | Chikako |
| Middle name | |
| Last name | Nishigori |
Organization
Kobe University Hospital
Division name
Dermatology
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6641
chikako@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kauhiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Kobe University Hospital
Division name
Pharmacy
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6659
Homepage URL
yamakz@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
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
Clinical and Translational Research Center, Kobe University Hospital
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel
078-382-6669
chiken@med.kobe-u.ac.jp
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
https://www.researchprotocols.org/2019/8/e14636/
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/oncolo/advance-article/doi/10.1093/oncolo/oyab067/6548146
Number of participants that the trial has enrolled
24
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
| 2017 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
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
| 2022 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031174
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