UMIN-CTR Clinical Trial

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

Advanced or recurrent cancer

Classification by specialty

Surgery in general	Gastrointestinal surgery	Chest surgery
Obstetrics and Gynecology	Dermatology

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Interventional

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

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

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

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

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

Institute

Aichi Medical University School of Medicine, Department of Tumor Immunology

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

02

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

02

Month

15

Day

Last modified on

2017

Year

02

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011768