UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005787
Receipt No. R000006430
Scientific Title Phase 1/2 study of GBS-01 in patients with gemcitabine-refractory advanced pancreatic cancer.
Date of disclosure of the study information 2011/06/16
Last modified on 2014/05/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase 1/2 study of GBS-01 in patients with gemcitabine-refractory advanced pancreatic cancer.
Acronym GBS-01 Phase I/II
Scientific Title Phase 1/2 study of GBS-01 in patients with gemcitabine-refractory advanced pancreatic cancer.
Scientific Title:Acronym GBS-01 Phase I/II
Region
Japan

Condition
Condition Patients with gemcitabine-refractory advanced pancreatic cancer.
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase 1 part
To determine a recommended dose of GBS-01 in patients with gemcitabine-refractory advanced pancreatic cancer.
Phase 2 part
To evaluate the efficacy and safety of GBS-01 in the same population.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phase 1:Frequency of dose limiting toxicities
Phase 2:Response rate
Key secondary outcomes PK parameter
Adverse events
Progression free survival
Overall survival

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 administered orally once daily until disease progression or unacceptable toxicity.
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 (papillary adenocarcinoma, tubular adenocarcinoma -well differentiated type, -moderately differentiated type , poorly differentiated adenocarcinoma, adenosquamous carcinoma)
2) Refractory to gemcitabine-based chemotherapy by the following reason.
i)Radiologically or clinically confirmed progression disease
ii) Recurrence during or within 12 weeks after administration of the adjuvant chemotherapy
iii)Unacceptable toxicities
3) Adequate oral intake
4) Having a measurable lesion according to RECIST ver1.1
5) Aged 20 or over
6) PS (ECOG) of 0 to 2
7) More than 14 days interval from prior chemotherapy.
8) Adequate organ function
9) Written informed consent
Key exclusion criteria 1) Moderate or massivepleural effusion or ascites
2) Symptomatic brain metastasis or a history of brain metastasis
3) Synchronous or asynchronous (within 3 years) other cancer except carcinoma in situ or intramucosal carcinoma.
4) Severe mental disorder
5) Active infection
6) Serious complications (intestinal paralysis, intestinal obstruction, poorly controlled diabetes, heart failure, renal failure, hepatic failure , active gastrointestinal ulcer)
7) Women during pregnancy or breast-feeding
8) Inadequate physical condition
Target sample size 23

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Esumi
Organization National Cancer Center Research Institute
Division name Office of Director
Zip code
Address 5-1-1 Tsukiji Chuo-ku Tokyo, 104-0045 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Cancer Center Hospital East
Division name Hepatobiliary and Pancreatic Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
Homepage URL
Email

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 University of Toyama
Kracie Pharma, Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立がん研究センター東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 16 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 Completed
Date of protocol fixation
2011 Year 06 Month 03 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 06 Month 16 Day
Last modified on
2014 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006430

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.