UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase 2 trial of nab-paclitaxel, oxaliplatin, S1 and itraconazole for unresectable pancreatic cancer
Title of the study (Brief title)	Combination chemotherapy with itraconazole for pancreatic cancer
Region	Japan

Condition
Condition	Unresectable pancreatic cancer
Classification by specialty	Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficiency and safety of nab-paclitaxel,oxaliplatin, S-1 and itraconazole for unresectable pancreatic cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate, operability
Key secondary outcomes	Overall survival, progression free survival, disease conctrol rate, adverse events

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	itraconazole 400 mg po day -2~+3 nabpaclitaxel 125 mg/m2 day 1 gemcitabine 1000 mgm2 day 1 L-OHP 85 mg/m2 day 1 q14d
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Stage IV pancreatic cancer no previous chemotherapy
Key exclusion criteria	diarrhea
Target sample size	28

Research contact person
Name of lead principal investigator	Takashi Sonoda
Organization	Meiwa Hospital
Division name	Medical Oncology
Address	Nishinomiya Agenaruo 4-31
TEL	0798-47-1767
Email	tsuba@hyo-med.ac.jp

Public contact
Name of contact person	Takashi Sonoda
Organization	Meiwa Hospital
Division name	Medical Oncology
Address	Nishinomiya Agenaruo 4-31
TEL	0798-47-1767
Homepage URL
Email	tsuba@hyo-med.ac.jp

Sponsor
Institute	Meiwa Hospital
Institute
Department

Funding Source
Organization	Meiwa Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 12 Month 27 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 05 Month 25 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 26 Day
Last modified on	2016 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029075