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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002700
Receipt No. R000003162
Scientific Title Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors
Date of disclosure of the study information 2009/11/04
Last modified on 2014/12/05

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Basic information
Public title Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors
Acronym Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors
Scientific Title Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors
Scientific Title:Acronym Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors
Region
Japan

Condition
Condition Solid Tumors
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish the safety of OTS11101.In addition,this trial will guide decision making for dose selection in subsequent studies.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes The incidence of adverse event and Dose-Limiting Toxicity(DLT).
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 OTS11101 1.0mg/ml will be administered by subjection Once a week at 4 times.Transition to the next cohort will be decided following evaluation of the development of DLT.
Interventions/Control_2 OTS11101 2.0mg/ml will be administered by subjection Once a week at 4 times.Transition to the next cohort will be decided following evaluation of the development of DLT.
Interventions/Control_3 OTS11101 3.0mg/ml will be administered by subjection Once a week at 4 times.
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients with histologically or cytologically documented advanced solid tumors.
(2) Patients who are refractory to standard therapy or for which no standard therapy is available.
(3) Patients must be >=20 years old at the time of obtaining informed consent.
(4) ECOG Performance Status must be 0 or 1.
(5) Patients must have HLA-A*2402.
(6) Life expectancy must be >=3 months.
(7) Patients who are free of marked failure of major organ function, more over the following criteria must be satisfied in laboratory tests.
1. Hematopoietic function
White blood cell count: >=3000/mm3, <=12000/mm3
Hemoglobin: >=9g/dl
Platelet count: >=100000/mm3
(G-CSF, Erythropoetin, Blood products and transfusion must be untried within 2 weeks days before registration.)
2. Hepatic function
AST and ALT: <=2.5*Upper Limit of Normal(ULN),<=5.0*ULN in case of patients have metastasis in the liver.
Total bilirubin:<=1.5*ULN
3. Renal function
Cre: <=1.5*ULN
(8) Patients meeting the criteria of washing out period from the completion of the previous cancer treatment to the start date of OTS11101 administration.
1. Chemotherapy, Surgical remedy, Investigational products: >=4 weeks
Bisphosphonate: >=2 weeks
2. Radiotherapy: >=2 weeks
Exclude the patient who has been irradiated at all sites of administration in this study where the injection is administrated in this study.
3. Systemic corticosteroid administration: >=2 weeks
(9) Patients who can be hospitalized for the period provided for protocol.
(10) Informed consent must be obtained.
Key exclusion criteria (1) Symptomatic brain metastasis.
(2) Pleural effusion, ascites fluid, pericardial fluid requiring drainage.
(3) Unhealed traumatic lesion, including traumatic fracture.
(4) History of clinically important bleeding.
(5) History of myocardial infarction, severe unstable angine pectoris, CABG, congestive heart failure, cerebrovascular accident, pulmonary embolism, deep-vein thrombosis, or other severe thromboembolism within 12 months before administration of OTS11101.
(6) Uncontrolled hypertension (Systolic pressure>=140mmHg, Diastolic pressure>=90mmHg), serious arrhythmia or cardiac failure.
(7) Other serious complication.
(8) Patients who require systemic administration of the following agents during the study treatment period.
1. Corticosteroid
2. Anticoagulant
3. Immunosuppresant, Immunostimulant
4. G-CSF
5. Erythropoietin
(9) Current participation in other drug clinical trials.
(10) Woman who is pregnant, breast feeding and child-bearing potential.
(11) Patient or patients partner unwilling to use adequate contraception during the study period and until 180 days after the last administration day for male, or until 120 days after the last administration day for female.
(12) As determined by the principal investigator or the sub-investigator the subject are not adequate to participate in the trial.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masami Sakai
Organization Research & Development dept
Division name Clinical deveropment dept
Zip code
Address Kanagawa Science Park R&D D11F,3-2-1,Sakado,Takatsu-ku,Kawasaki City,Kanagawa Pref.213-0012 Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Research & Development dept
Division name Clinical deveropment dept
Zip code
Address Kanagawa Science Park R&D D11F,3-2-1,Sakado,Takatsu-ku,Kawasaki City,Kanagawa Pref.Japan.
TEL
Homepage URL
Email

Sponsor
Institute Oncotherapy science,Inc.
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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
2009 Year 11 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1111/cas.12034/pdf
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
2009 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2010 Year 11 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 02 Day
Last modified on
2014 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003162

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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