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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010050
Receipt No. R000011768
Scientific Title Phase Ia/Ib multicenter investigator initiated trial of Mogamulizumab for advanced or recurrent cancer.
Date of disclosure of the study information 2013/02/15
Last modified on 2017/02/20

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Basic information
Public title Phase Ia/Ib multicenter investigator initiated trial of Mogamulizumab for advanced or recurrent cancer.
Acronym Phase Ia/Ib multicenter investigator initiated trial of Mogamulizumab for advanced or recurrent cancer.
Scientific Title Phase Ia/Ib multicenter investigator initiated trial of Mogamulizumab for advanced or recurrent cancer.
Scientific Title:Acronym Phase Ia/Ib multicenter investigator initiated trial of Mogamulizumab for advanced or recurrent cancer.
Region
Japan

Condition
Condition Advanced or recurrent cancer
Classification by specialty
Surgery in general Gastrointestinal surgery Chest surgery
Obsterics and gynecology Dermatology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 <Phase Ia>
To assess the safety and pharmacokinetics of weekly repeated doses of Mogamulizumab.
<Phase Ib>
To assess the safety and effect of Treg depletion of weekly repeated doses of Mogamulizumab.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes <Phase Ia>
Maximum tolerated dose(MTD)
Dose limiting toxicity(DLT)
Adverse events
Pharmacokinetics
<Phase Ib>
Adverse events
Effect of Treg depletion
Key secondary outcomes <Phase Ia>
Effect of Treg depletion
Response rate
Progression-free survival(PFS)
Overall survival(OS)
<Phase Ib>
Response rate
Progression-free survival(PFS)
Overall survival(OS)
To determine recommended dose of Mogamulizumab

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 <Phase Ia>
Mogamulizumab 0.1mg/kg will be administered 8 times every week.
Interventions/Control_2 <Phase Ia>
Mogamulizumab 0.5mg/kg will be administered 8 times every week.
Interventions/Control_3 <Phase Ia>
Mogamulizumab 1.0mg/kg will be administered 8 times every week.
Interventions/Control_4 <Phase Ib>
Mogamulizumab of the tolerated dose in Phase Ia will be administered 8 times every week.
Interventions/Control_5 <Phase Ib>
Mogamulizumab 0.1mg/kg will be administered 8 times every week.
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) Tumor cells are judged CCR4 negative, and patients with lung cancer, stomach cancer, esophageal cancer, malignant melanoma or ovarian cancer, which is histologically confirmed.
(2) Patients with refractory or intolerable to standard therapy, patients who have no standard therapy or refuse standard therapy.
(3) Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1 or 2.
(4) Patients should be 20 years or older at informed consent.
(5) No serious disorder of major organs (bone marrow, heart, lung, liver and kidney) and meet the following conditions ;
1) WBC count : >=1,500/mm3
2) Hemoglobin : >=8.0g/dL
3) Platelet count : >=75,000/mm3
4) Serum total bilirubin : <=2.0 x ULN
5) AST and ALT : <=2.5 x ULN
(Patients with hepatic infiltration which is attributed to primary disease<=5.0 x ULN)
6) Serum creatinine : <=1.5 mg/dL
7) SpO2 : >=93 %
8) ECG : No abnormal findings.
9) EF : >=50 %
(6) Agree to use birth control including condom etc. from the time of obtaining the first consent to 24 weeks after the final administration of the study drug (except female after menopause (1 year or more after the last menstruation) and female/male after the operation for sterilization).
(7) Given written informed consent.
(8) Patients who can be hospitalized from the day of first administration to the next day.
(9) Patients who have target lescion(s) measurable by RECIST ver.1.1.
(10) Life expectancy >= 3 months.
Key exclusion criteria (1) Patients with HIV antibody positive.
(2) Patients with HCV antibody positive.
(3) Patients with autoimmune disease.
(4) Patients with HBs antigen or HBV-DNA positive.
(5) History of serious anaphylaxis induced by antibody preparation.
(6) Patients with double cancer.
(7) Within 4 weeks after treatment with anticancer agent, immune suppressant, immune enhancer, cytokine therapy, radiotherapy or surgery for the primary disease.
(8) Pregnant or breast-feeding females and females who have a possibility of pregnancy.
(9) Patients with active infection.
(10) Patients with psychosis or dementia.
(11) Patients who need continuous systemic administration of adrenocorticosteroid.
(12) Patients who have received hematopoietic stem cell transplantation.
(13) Patients who have presence or suspicion of CNS involvement.
(14) Patients who are administered the other investigational product within 4 weeks of the entry.
(15) Patients treated with immunotherapy for cancer (e.g. cancer vaccine therapy) within 12 weeks of the entry.
(16) Any other inadequacy for this study.
Target sample size 58

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuzo Ueda MD, PhD
Organization Aichi Medical University School of Medicine
Division name Department of Tumor Immunology
Zip code
Address 1-1, Yazakokarimata, Nagakute, Aichi, 480-1195 Japan
TEL 0561-62-3311
Email tumorimm@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Miyamoto
Organization Secretariat of clinical trial coordinating committee
Division name (none)
Zip code
Address Chiyoda-BLDG east, 2-9-4, Higashitenma, Kita-ku, Osaka 530-0044 Japan
TEL 06-6358-7110
Homepage URL http://www.iit-portal.info/aichi-med-u/
Email kw0761_jimukyoku@fiverings.co.jp

Sponsor
Institute Aichi Medical University School of Medicine, Department of Tumor Immunology
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 15 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
2012 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 19 Day
Last follow-up date
2016 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 15 Day
Last modified on
2017 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011768

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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