UMIN-CTR Clinical Trial

Public title

Phase 2a trial of GBS-01 for advanced pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapy.

Acronym

GBS-01 Phase IIa

Scientific Title

Phase 2a trial of GBS-01 for advanced pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapy.

Scientific Title:Acronym

GBS-01 Phase IIa

Region

Japan

Condition

Advanced pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapy

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Masafumi Ikeda

Organization

National Cancer Center Hospital East

Division name

Division of Hepatobiliary and Pancreatic Oncology

Zip code

Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

TEL

04-7133-1111

Email

gbs_core@east.ncc.go.jp

Name of contact person

1st name
Middle name
Last name	Akihiro Sato

Organization

National Cancer Center Exploratory Oncology Research & Clinical Trial Center

Division name

Clinical Trial Section

Zip code

Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

TEL

04-7133-1111

Homepage URL

Email

gbs_core@east.ncc.go.jp

Institute

National Cancer Center Hospital East

Institute

Department

Personal name

Organization

Health and Labor Sciences Research Grant

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Kracie Pharma, Ltd.

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2013

Year

03

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

12

Month

18

Day

Date of IRB

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

Other related information

Registered date

2013

Year

02

Month

25

Day

Last modified on

2016

Year

10

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011733