UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006119 |
|---|---|
| Receipt number | R000007238 |
| Scientific Title | GLIF phase I/II study for taxane-and-platinum-resistant endometrial carcinoma |
| Date of disclosure of the study information | 2011/08/08 |
| Last modified on | 2016/08/08 09:43:11 |
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Basic information
Public title
GLIF phase I/II study for taxane-and-platinum-resistant endometrial carcinoma
Acronym
GLIF study
Scientific Title
GLIF phase I/II study for taxane-and-platinum-resistant endometrial carcinoma
Scientific Title:Acronym
GLIF study
Region
| Japan |
Condition
Condition
endometrial carcinoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Evaluation of safety and effectiveness of GLIF therapy for endometrial carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
side effect
anti-tumor effect
Key secondary outcomes
survival effect
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
chemotherapy
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
Female
Key inclusion criteria
1) age >= 20y
2) PS=0,1,2
3)Refractory or resistant to taxane and platinum (TFI<6 months)
4)life expectancy >= 3 months
5)
WBC >=3000/mm3,<=12000/mm3
Neu >=1500/mm3
Plt >=100000/mm3
Hb >=8.0g/dl
AST,ALT <= x2.5
Bil<= x1.5
Cr WNL
6) obtainment of informed consent
Key exclusion criteria
1) severe allergy to drugs
2) obvious interstitial pneumonia
3) massive ascites or pleural effusion to discharge
4) severe infection
5) complication of another malignancy
6) pregnant women
7) severe mental disease
8) brain metstasis with symptoms
9) severe cardiac disease
10) severe DM
11) diarrhea
12) ileus
13) fresh intestinal bleeding
14) other severe complications
15) systemic edema
16) inadequate cases judged by a doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Ueda |
Organization
Osaka University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Ueda |
Organization
Osaka University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
TEL
Homepage URL
ZVF03563@nifty.ne.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and Gynecology
Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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 | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 05 | Day |
Last modified on
| 2016 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007238
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
