UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002876 |
|---|---|
| Receipt number | R000003186 |
| Scientific Title | Continuous administration trial of OTS11101 |
| Date of disclosure of the study information | 2009/12/14 |
| Last modified on | 2014/12/05 14:58:19 |
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Basic information
Public title
Continuous administration trial of OTS11101
Acronym
Continuous administration trial of OTS11101
Scientific Title
Continuous administration trial of OTS11101
Scientific Title:Acronym
Continuous administration trial of OTS11101
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 continuous administration.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of adverse event.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
expanded access
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.
When the recommended dose is decided by [Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors], administering the recommended dose begins.
Interventions/Control_2
OTS11101 2.0mg/mL will be administered by subjection once a week.
When the recommended dose is decided by [Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors], administering the recommended dose begins.
Interventions/Control_3
OTS11101 3.0mg/mL will be administered by subjection once a week.
When the recommended dose is decided by [Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors], administering the recommended dose begins.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) In [Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors], patients who completed the end of clinical inspection without drop out.
(2) After [Phase1 Study of OTS11101 in Patients with Solid Cancer], patients wish to continue to use of OTS11101, there is no obvious underlying disease progression, and there is the clinical benefit in patients by continued use of OTS11101 were judged by the investigator or subinvestigator.
(3) ECOG Performance Status must be 0 to 2.
(4) 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
(5) Patients who hope for continued administration of investigational new drug by patients themselves, and an agreement for this clinical trial participation is provided by a document.
Key exclusion criteria
(1) In [Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors], patients who experienced serious adverse events not to be denied the causal relationship between OTS11101.
(2) In [Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors], Patients showed a obvious progression of the underlying disease.
(3) Symptomatic brain metastasis.
(4) Pleural effusion, ascites fluid, pericardial fluid requiring drainage.
(5) Unhealed traumatic lesion, including traumatic fracture.
(6) History of clinically important bleeding.
(7) 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.
(8) Uncontrolled hypertension (Systolic pressure>=140mmHg, Diastolic pressure>=90mmHg), serious arrhythmia or cardiac failure.
(9) Other serious complication.
(10) 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
(11) Patients who are participating in clinical trials except [Phase1 Clinical Trial of OTS11101 in Subjects with Solid Tumors].
(12) Woman who is pregnant, breast feeding and child-bearing potential.
(13) 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.
(14) As determined by the principal investigator or the sub-investigator the subject are not adequate to participate in the trial.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masami Sakai |
Organization
Reserch & deveropment division
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
Reserch & deveropment division
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 | 12 | Month | 14 | 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 | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 11 | 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=R000003186
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| Registered date | File name |
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