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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030007
Receipt No. R000034268
Scientific Title Phase1/2 study of Nabpaclitaxel,Gemcitabine,S1 combination therapy for unresectable pancreatic cancer
Date of disclosure of the study information 2017/11/17
Last modified on 2019/05/15

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Basic information
Public title Phase1/2 study of Nabpaclitaxel,Gemcitabine,S1
combination therapy for unresectable pancreatic cancer
Acronym GENeS1S
Scientific Title Phase1/2 study of Nabpaclitaxel,Gemcitabine,S1
combination therapy for unresectable pancreatic cancer
Scientific Title:Acronym GENeS1S
Region
Japan

Condition
Condition unresectable pancreatic cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase 1 part:
Evaluate the toxicity of NGS therapy and decide recommended dose

Phase 2 part:
To examine the efficacy and safety of the recommended dose
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phase 1 part:
determination of maximum tolerated dose and recommended dose

Phase 2 part:
response rate
Key secondary outcomes

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 24 weeks
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.Histological diagnosis of pancreatic cancer and unresectable pancreatic cancer or non-curative resection except for chemotherapy and radiotherapy or recurrence of curative resection
2.over 20 years old
3.ECOG PS 0 or 1
4.one more measurable lesions based on RECIST
5.no previous treatment of chemotherapy,radiotherapy and immunotherapy except for biliary drainage
6. major organ function is held
1.Neutrophil count is over 500 per mm3
2.Hb is over 9.0g per dL
3.Platelet count is over 100000 per mm3
4.T.Bil is under one and a half times Reference value upper limit
5.AST,ALT is under 3 times Reference value upper limit
6.Ccr is over 60ml per min
7.no serious complications
8.ingestible
9.CIPN is under Grade1
10.consent is obtained
Key exclusion criteria 1.Interstitial pneumonitis or pulmonary fibrosis
2.uncontorolled diabetes, liver failure, angina pectoris,myocardial infarction within 3 months after the onset
3.severe infection
4.pregnant woman,lactation,possibility or intention of pregnancy
5.serious drug allergy
6.psychiatric symptoms or mental illness
7.Moderate or severe ascites, pleural effusion
8.uncontrolled watery diarrhea
9.unsuitable for safely carrying out this trial
10.double cancer affected performance status
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Masanori
Middle name
Last name Toyoda
Organization Kobe University Hospital
Division name Department of Hematology and Oncology
Zip code 6500017
Address 7-5-2 kusunoki-chou tyuo-ku kobe-shi
TEL 078-382-5111
Email kobetoyo@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Sai
Organization Kobe University Hospital
Division name Department of Hematology and Oncology
Zip code 6500017
Address 7-5-2 kusunoki-chou tyuo-ku kobe-shi
TEL 078-382-5111
Homepage URL
Email s313104@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
Department of Hematology and Oncology
Institute
Department

Funding Source
Organization Kobe University Hospital
Department of Hematology and Oncology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kobe University School of Medicine Hospital Clinical Research Promotion Center
Address 7-5-2 kusunoki-chou tyuo-ku kobe-shi
Tel 078-382-6667
Email chiken@med.kobe-u.ac.jp

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
2017 Year 11 Month 17 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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 22 Day
Date of IRB
2018 Year 02 Month 27 Day
Anticipated trial start date
2018 Year 02 Month 27 Day
Last follow-up date
2020 Year 02 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 17 Day
Last modified on
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034268

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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