UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2a trial of GBS-01 for advanced pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapy.
Title of the study (Brief title)	GBS-01 Phase IIa
Region	Japan

Condition
Condition	Advanced pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapy
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and safety of GBS-01 in patients with advanced pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Disease control rate (DCR)
Key secondary outcomes	Adverse events Response rate (RR) Progression free survival (PFS) Overall survival (OS) PK parameter effect to cancer stem-like cell

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	GBS-01 is orally administered at the dose of 6g q.d.
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	1)Histologically proven invasive ductal carcinomas of pancreas (papillary adenocarcinoma, tubular adenocarcinoma -well differentiated type, -moderately differentiated type ,or poorly differentiated adenocarcinoma, adenosquamous carcinoma) 2)Refractory to gemcitabine and fluoropyrimidine chemotherapy by the following reason. i)Radiologically or clinically confirmed progression disease ii)Recurrence during or within 12 weeks after the last administration of the adjuvant/ neoadjuvant chemotherapy 3)Adequate oral intake 4)Having a measurable lesion according to RESICT ver1.1 5)Aged 20 or over 6)PS (ECOG) of 0 to 1 7)The period from the end of previous treatment to the enrollment must be satisfied following criteria. - GEM, S-1, GEM+S-1, GEM+erlotinib, immunotherapy, or palliative radiotherapy: >=14 days - other chemotherapy or radiotherapy for pancreas : >=28 days 8)Adequate organ function 9)Written informed consent
Key exclusion criteria	1)Prior treatment of medicines or supplements extracted from Arctium lappa linne for pancreatic cancer 2)Lactose intolerance 3)Moderate or massive pleural effusion or ascites 4)Symptomatic brain metastasis or a history of brain metastasis 5)Synchronous or asynchronous (within 3 years) other cancer except carcinoma in situ or intramucosal carcinoma. 6)Psychiatric disease 7)Active infection that requires systemic therapy 8)Other serious complications 9)Pregnant females or nursing mothers who can't stop lactation after the recruitment. Patients or partners, who don't attempt to doing contraception during the study period. 10)Patient is judged as inappropriate for study participation by the investigator for any reason.
Target sample size	47

Research contact person
Name of lead principal investigator	Masafumi Ikeda
Organization	National Cancer Center Hospital East
Division name	Division of Hepatobiliary and Pancreatic Oncology
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Email	gbs_core@east.ncc.go.jp

Public contact
Name of contact person	Akihiro Sato
Organization	National Cancer Center Exploratory Oncology Research & Clinical Trial Center
Division name	Clinical Trial Section
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Homepage URL
Email	gbs_core@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Health and Labor Sciences Research Grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Kracie Pharma, Ltd.
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	独立行政法人国立がん研究センター東病院（千葉県） 独立行政法人国立がん研究センター中央病院（東京都） 公益財団法人がん研究会 有明病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 18 Day
Anticipated trial start date	2013 Year 03 Month 11 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	2013 Year 02 Month 25 Day
Last modified on	2016 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011733