UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011157 |
|---|---|
| Receipt number | R000013068 |
| Scientific Title | Exploratory analysis of biomarker related to RO4987655 in patients with advanced solid tumors |
| Date of disclosure of the study information | 2013/07/10 |
| Last modified on | 2015/01/09 09:39:24 |
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Basic information
Public title
Exploratory analysis of biomarker related to RO4987655 in patients with advanced solid tumors
Acronym
Exploratory analysis of biomarker related to RO4987655 in patients with advanced solid tumors
Scientific Title
Exploratory analysis of biomarker related to RO4987655 in patients with advanced solid tumors
Scientific Title:Acronym
Exploratory analysis of biomarker related to RO4987655 in patients with advanced solid tumors
Region
| Japan |
Condition
Condition
Patients with advanced solid tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Identification of biomarker related to efficacy of RO4987655 in patients who received RO4987655
Basic objectives2
Others
Basic objectives -Others
Identification of biomarker related to efficacy of RO4987655 in patients who enrolled into phase I clinical trial in patients with advanced solid tumors (JapicCTI-111490) and received RO4987655.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of biomarker related to efficacy of RO4987655
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who enrolled into phase I clinical trial in patients with advanced solid tumors (JapicCTI-111490), received RO4987655, and consented to provide archival tumor tissue or biopsy samples.
Key exclusion criteria
Not applicable
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhide Yamada |
Organization
National Cancer Center Hospital
Division name
Division of Gastrointestinal Oncology
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
yayamada@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhide Yamada |
Organization
National Cancer Center Hospital
Division name
Division of Gastrointestinal Oncology
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
yayamada@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chugai Pharmaceutical Co., Ltd.
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
| 2013 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.myschedule.jp/jsmo2014/
Number of participants that the trial has enrolled
Results
No new biomarkers related to response were elucidated.
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
| 2013 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective analysis for identification of biomarker related to efficacy data from phase I clinical trial in patients with advanced solid tumors (JapicCTI-111490).
Management information
Registered date
| 2013 | Year | 07 | Month | 09 | Day |
Last modified on
| 2015 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013068
