UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	tsuba@hyo-med.ac.jp

Sponsor
Institute	Department of Obstetrics and Gynecology, Hyogo College of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016257