UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase Ia/Ib multicenter investigator initiated trial of Mogamulizumab for advanced or recurrent cancer.
Title of the study (Brief title)	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	Ryuzo Ueda MD, PhD
Organization	Aichi Medical University School of Medicine
Division name	Department of Tumor Immunology
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	Hiroshi Miyamoto
Organization	Secretariat of clinical trial coordinating committee
Division name	(none)
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011768