UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005787 |
|---|---|
| Receipt number | 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 09:41:35 |
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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
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
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006430
