UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013951 |
|---|---|
| Receipt number | R000016257 |
| Scientific Title | Phase II study of concurrent chemotherapy with itraconazole in advanced gynecologic tumors. |
| Date of disclosure of the study information | 2014/05/20 |
| Last modified on | 2020/05/17 15:40:13 |
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Basic information
Public title
Phase II study of concurrent chemotherapy with itraconazole in advanced gynecologic tumors.
Acronym
P2 trial of itraconazole
Scientific Title
Phase II study of concurrent chemotherapy with itraconazole in advanced gynecologic tumors.
Scientific Title:Acronym
P2 trial of itraconazole
Region
| Japan |
Condition
Condition
Gynecologic cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Tto determine the efficacy and safety of combination chemotherapy with itraconazole for gynecologic malignancy, and to define the molecular profile of the responders.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PFS, Response rate, OS, AEs, QOL, molecular profiling
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
itraconazole with 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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
1. advanced or metastatic sarcoma
2. symptomatic or radiological recurrence within 6 months after last platinum administration of ovarian, fallopian, peritoneal, endometrial, and/or cervical cancers.
Key exclusion criteria
history of gemecitabine or docetaxel
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tsubamoto |
Organization
Hyogo College of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
663-8501
Address
Mukogawa 1-1, Nishinomiya, Hyogo, 663-8501
TEL
+81-798-45-6481
tsuba@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tsubamoto |
Organization
Hyogo College of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
663-8501
Address
Mukogawa 1-1, Nishinomiya, Hyogo, 663-8501
TEL
+81-798-45-6481
Homepage URL
tsuba@hyo-med.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College of Medicin
Address
Mukogawa 1-1, Nishinomiya, Hyogo
Tel
+81798456111
rinsys@hyo-med.ac.jp
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
| 2014 | Year | 05 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 13 | Day |
Last modified on
| 2020 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016257
