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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012943
Receipt No. R000015136
Scientific Title Phase I Dose-escalation, Safety / Tolerability and Preliminary Efficacy Study of Intratumoral Administration of GEN0101 in Patients with Advanced Melanoma.
Date of disclosure of the study information 2014/03/01
Last modified on 2017/01/17

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Basic information
Public title Phase I Dose-escalation, Safety / Tolerability and Preliminary Efficacy Study of Intratumoral Administration of GEN0101 in Patients with Advanced Melanoma.
Acronym Phase I study of GEN0101 in Patients with Advanced Melanoma.
Scientific Title Phase I Dose-escalation, Safety / Tolerability and Preliminary Efficacy Study of Intratumoral Administration of GEN0101 in Patients with Advanced Melanoma.
Scientific Title:Acronym Phase I study of GEN0101 in Patients with Advanced Melanoma.
Region
Japan

Condition
Condition Advanced Melanoma
Classification by specialty
Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Assessing the Safety and Tolerability of GEN0101
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Assessing the Safety and Tolerability of GEN0101
Key secondary outcomes Assessing the antitumor immunity and validity of GEN0101

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 open-label ,multicenter trial
Patients receive GEN0101 (30,000m NAU/day or 60,000 mNAU/day) intratumorally 2 triweekly every 4 weeks (week 1 and 2). One such cycle is repeated 2 cycles.
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
86 years-old >
Gender Male and Female
Key inclusion criteria 1) The patient is Able to understand and sign the Informed Consent Document.
2) The patient is at least more than 20 years and less than 86 years old.
3) The patient has a diagnosis of malignant tumor as confirmed by histopathology or cytology.
4) The patient has a diagnosis of malignant melanoma progressive melanoma in AJCC stage IIIC or stage IV who meets either below condition;
Recurrent
Refractory or inapplicable to a standard treatment
The patient refuses a standard treatment.
5) The patient has measurable or evaluable superficial skin lesions, 10 mm or larger (more than 3 sites and each site must be more than 3mm).
6) The patient has a life expectancy for at least 8 weeks or more.
7) The patient has a ECOG Performance Status Scale of 0 or 2.
8) The organs function adequately evaluated by the following lab values;
WBC: equal or more than 2,000/uL
PLT: equal or more than 75,000/uL
Hemoglobin: equal or more than 8.0 g/dL
AST:<local reference range 2.5
ALT:<local reference range 2.5
T-Bil:<local reference range 2
Serum creatinine:<local reference range 2
Key exclusion criteria 1) The patient has multiple brain metastases.
2) The patient shows positive immune response by GEN0101 prick test at screening.
3) The patient has a uncontrolled serious complication such as active infection.
4) Chemotherapy, radiotherapy, local IFN-b therapy, and/or any other therapy with established or suggested anti-cancer effects within 4 weeks (in case of Nitrosoureas or Mitomycin C: within 6 not 4 weeks).
5) Participation in another clinical trial of another investigational medical product within 4 weeks.
6) History of a second independent malignancy within 5 years.
7) History of active autoimmune disease
8) The patient is undergoing on systemic corticosteroids or immunosuppressive agents except for the use of maximum 10 mg/day oral prednisolone over 6 months.
9) The patient is a pregnant or lactating female.
10) The patient has any serious psychiatric disorders that may be unwilling or unable to comply with protocol requirements and scheduled visits.
11) The patient has a history of a transplantation of the allogeneic ogan, the autologous ogan or tissue.
12) The patient shows adequate blood property with PT and APTT more than 1.5 times of the upper limit of local reference range.
13) The patient has hepatitis Be antigen, hepatitis C antibody or human immunodeficiency virus (HIV1,2) antibody positive status.
14) The Patient is inappropriate to be enrolled in this study judged by the doctors in charge.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Katayama
Organization Osaka University Hospital
Division name Dermatology
Zip code
Address 2-15 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL 06-6879-5111
Email katayama@derma.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Tanemura
Organization Osaka University Hospital
Division name Dermatology
Zip code
Address 2-15 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL 06-6879-5111
Homepage URL
Email tanemura8@hotmail.co.jp

Sponsor
Institute Department of Dermatology Course of Integrated Medicine Graduate School of Medicine, Osaka University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 大阪大学医学部附属病院(大阪府)、国立がん研究センター中央病院(東京都)、静岡県立静岡がんセンター(静岡県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 01 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
2013 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 07 Day
Last follow-up date
2016 Year 05 Month 02 Day
Date of closure to data entry
2016 Year 06 Month 29 Day
Date trial data considered complete
2016 Year 06 Month 29 Day
Date analysis concluded
2016 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 24 Day
Last modified on
2017 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015136

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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