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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036527
Receipt No. R000041614
Scientific Title A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy and Safety of NPC-12G for Skin Lesions in Patients with Neurofibromatosis type 1
Date of disclosure of the study information 2019/04/22
Last modified on 2019/05/11

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Basic information
Public title A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy and Safety of NPC-12G for Skin Lesions in Patients with Neurofibromatosis type 1
Acronym NEDOC-2 Study
Scientific Title A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy and Safety of NPC-12G for Skin Lesions in Patients with Neurofibromatosis type 1
Scientific Title:Acronym NEDOC-2 Study
Region
Japan

Condition
Condition Neurofibromatosis type 1
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of NPC-12G at doses of 0.2% and 0.4% compared with placebo based on the changes in the volume of cutaneous tumor in patients with Neurofibromatosis type 1
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Response rate on the changes from baseline in the volume of cutaneous tumor (measured with 3D camera) after 52 week treatment
Key secondary outcomes 1) Time course of changes from baseline in the volume of cutaneous tumor (measured with 3D camera)
2) Response rate on the changes from baseline in the volume of cutaneous tumor (measured with 3D camera) after 16 week, 28 week and 40 week treatment
3) Time course of changes from baseline in the area of cutaneous tumor (measured with ruler)
4) Improvement of cutaneous lesions after 28 and 52 week treatment judged by physician in charge

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
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 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 0.2% NPC-12G gel topically administered twice a day for 52 weeks
Interventions/Control_2 0.4% NPC-12G gel topically administered twice a day for 52 weeks
Interventions/Control_3 Placebo gel topically administered twice a day for 52 weeks
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
3 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients diagnosed as neurofibromatosis type 1 according to the clinical diagnostic criteria in guideline of Japanese Dermatological Association
2) Patients with 10 skin lesions (at least 5 lesions) that can be selected from those of the maximum size. The skin lesions can be taken pictures by 3D camera and must satisfy all of the following conditions.
a)Tumors of 3 mm or longer in longest diameter measured by ruler.
b)Tumors located solitary
c)Skin lesions without hair
d)Tumors of mountain-like shape with no shadows when taken pictures from above (bulb shape or gourd shape tumor should not be selected)
e)Tumors not located on the skin with large expansion and contraction such as inside of the elbow or the scruff.
3) Patients who is 3 years old or elder
4) Patients who provide written informed consent by themselves or legally acceptable representatives
Key exclusion criteria 1) Patients who treated with mTOR inhibitors (sirolimus, everolimus or temsirolimus), within 12 months prior to enrollment.
2) Patients who treated with RAS-MAPK inhibitors (sorafenib, regorafenib or lenvatinib), within 12 months prior to enrollment.
3) Patients who have active infectious lesions.
4) Patients who have abnormal findings (pneumonic lesions) by chest X-ray inspection.
5) Patients with creatinine clearance less than 50ml/min.
6) Patients with uncontrolled dyslipidemia (serum triglyceride is 500mg / dL or more, or LDL cholesterol is 190mg / dL or more even treated)
7) Patients who have severe complications such as cardiac disease, liver disease, pulmonary disease, hematological disorder or malignant tumor .
8) Patients who have previously experienced alcoholic sensitivity or allergy to sirolimus.
9) Patients who are pregnant or lactating.
10) Patients who cannot agree to use effective contraceptive methods during the study period and until 8 weeks after treatment.
11) Patients who have entered another clinical trial within 6 months prior to enrollment.
Target sample size 63

Research contact person
Name of lead principal investigator
1st name Mari
Middle name
Last name Kaneda
Organization Osaka University Hospital
Division name Department of Dermatology
Zip code 565-0871
Address 2-15 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3031
Email mkaneda@derma.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Mari
Middle name
Last name Kaneda
Organization Osaka University Hospital
Division name Department of Dermatology
Zip code 565-0871
Address 2-15 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3031
Homepage URL
Email mkaneda@derma.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Osaka University hospital
Address 2-2 Yamadaoka, Suita, Osaka, Japan
Tel 06-6210-8290
Email shiken@hp-crc.med.osaka-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 大阪大学医学部附属病院(大阪府)、東京慈恵会医科大学附属病院(東京都)、
鳥取大学医学部附属病院(鳥取県)、福岡大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 22 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
2019 Year 03 Month 22 Day
Date of IRB
2019 Year 03 Month 22 Day
Anticipated trial start date
2019 Year 05 Month 10 Day
Last follow-up date
2021 Year 02 Month 28 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 16 Day
Last modified on
2019 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041614

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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