UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012720
Receipt number 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 2021/06/08 15:28:02

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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 or person

Institute

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

Institute

Department

Personal name



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

No longer 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

2021 Year 06 Month 08 Day



Link to view the page

Value
https://center6.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