UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006436 |
|---|---|
| Receipt number | R000007639 |
| Scientific Title | Continuous administration trial of Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2014/12/05 16:02:32 |
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Basic information
Public title
Continuous administration trial of Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer
Acronym
Continuous administration trial of Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer
Scientific Title
Continuous administration trial of Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer
Scientific Title:Acronym
Continuous administration trial of Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer
Region
| Japan |
Condition
Condition
Unresectable Advanced and Recurrent Biliary Tract Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To provide the patient with OTS102 and Gemcitabine.
To evaluate the efficacy and safety of OTS102 in combination with Gemcitabine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall Survival (OS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
OTS102 1mL will be administered by subcutaneous injection on days,1,8,15 and 22 of each 28-day treatment cycles.
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days,1,8 and 15.
Interventions/Control_2
Interventions/Control_3
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) Patients who are administering OTS102 in Study202.
2) Patients who wish to continue to use of OTS102 and GEM, there is no obvious underlying disease progression, and there is the clinical benefit in patients by continued use of OTS102 and GEM.
3) ECOG Performance Status musut be 0 to 2.
4) Voluntarily signed the written consent form.
Key exclusion criteria
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masami Sakai |
Organization
OncoTherapy Science, Inc.
Division name
Clinical Development Dept., Research & Development Division
Zip code
Address
Kanagawa Science Park R&D D11F, 3-2-1, Sakado, Takatsu-ku, Kawasaki City, Kanagawa Pref Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
OncoTherapy Science, Inc.
Division name
Clinical Development Dept., Research & Development Division
Zip code
Address
Kanagawa Science Park R&D D11F, 3-2-1, Sakado, Takatsu-ku, Kawasaki City, Kanagawa Pref Japan
TEL
044-820-8251
Homepage URL
Sponsor or person
Institute
OncoTherapy Science, Inc.
Institute
Department
Personal name
Funding Source
Organization
FUSO Pharmaceutical Industries,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2011 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://2013.europeancancercongress.org/Scientific-Programme/Abstract-search?abstractid=6061
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
| 2011 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | 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
| 2011 | Year | 09 | Month | 29 | 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=R000007639
