UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002700 |
|---|---|
| Receipt number | 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 14:52:01 |
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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
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
Sponsor or person
Institute
Oncotherapy science,Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003162
