UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012943 |
|---|---|
| Receipt number | 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 14:35:28 |
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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
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
tanemura8@hotmail.co.jp
Sponsor or person
Institute
Department of Dermatology Course of Integrated Medicine Graduate School of Medicine, Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015136
