UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012720
Receipt No. R000013947
Scientific Title Pharmacogenomics study of gemcitabine on the safety and efficacy in metastatic pancreatic cancer patients
Date of disclosure of the study information 2014/01/01
Last modified on 2020/07/03

* 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 Pharmacogenomics study of gemcitabine on the safety and efficacy in metastatic pancreatic cancer patients
Acronym GENESECT study
Scientific Title Pharmacogenomics study of gemcitabine on the safety and efficacy in metastatic pancreatic cancer patients
Scientific Title:Acronym GENESECT study
Region
Japan

Condition
Condition Metastatic Pancreatic Cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate the association with genetic polymorphisms and CA19-9 response and adverse reactions of gemcitabine in metastatic pancreatic cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CA19-9 response: Reduction of >50% from the pretreatment level at 8 weeks after first gemcitabine administration.
Key secondary outcomes 1) Time to CA19-9 response during gemcitabine treatment

2) The proportion of CA19-9 decrease in the pre-treatment level and nadir level.

3) Overall survival

4) Adverse drug reactions

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Patients who confirmed the diagnosis of pancreatic cancer
2) Metastatic pancreatic cancer
3) 20 years of age or older
4) ECOG PS 0-2
5) No prior chemotherapy or radiotherapy before enrollment
6) Patients who scheduled for the standard dose of gemcitabine monotherapy or combination therapy with nab-Paclitaxel and gemcitabine as first line treatment
7)Patients with a serum CA19-9 level of >= 100 U/mL within 4 weeks prior to registration
8) Adequate organ function obtained within 4 weeks prior to registration.
Laboratory values must be as follows;
Absolute neutrophil count >= 1,500 /mm3,
Hemoglobin >= 9.0 g/dL
Platelet count >= 100,000 /mm3
AST <= 150 IU/L
ALT <= 150 IU/L
Total bilirubin less than or equal to 2.0 mg/dL(to be permitted <=3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice)
serum creatinine <= 1.5 mg/dL
9)Informed consent by the document
Key exclusion criteria 1) Known prior severe hypersensitivity to clinical trial medicines
2)Patients with an active concomitantly existed
3)Patients with an active concomitant infection
4)Patients with pulmonary fibrosis or interstitial pneumonia
5)Patient with severe uncontrollable diabetes mellitus
6)Pregnant, breastfeeding or expecting woman
7)Other clinical difficulties in this study
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Kunihiko
Middle name
Last name ITOH
Organization Univercity of Shizuoka
Division name School of Pharmaceutical Science
Zip code 422-8526
Address 52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL 054-264-5674
Email ithok@u-shizuoka-ken.ac.jp

Public contact
Name of contact person
1st name Daiki
Middle name
Last name TSUJI
Organization Univercity of Shizuoka
Division name School of Pharmaceutical Science
Zip code 422-8526
Address 52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL 054-264-5674
Homepage URL
Email d-tsuji@u-shizuoka-ken.ac.jp

Sponsor
Institute Department of Clinical Pharmacology and Genitics, School of Pharmaceutical Science, Univercity of Shizuoka
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The Cancer Institute Hospital Of JFCR
Address 3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
Tel 03-3520-0111
Email tiken@ml.jfcr.or.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
2014 Year 01 Month 01 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
2013 Year 11 Month 05 Day
Date of IRB
2014 Year 03 Month 06 Day
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Blood samples are collected from metastatic pancreatic cancer patients before gemcitabine administration. Relationship between efficacy of gemcitabine and genitic polymorphisms are assessed.

Management information
Registered date
2013 Year 12 Month 28 Day
Last modified on
2020 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013947

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.