UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054612 |
|---|---|
| Receipt number | R000062394 |
| Scientific Title | Pharmacokinetics and Prediction of Adverse Effects by EOB-MRI in the Treatment of Pancreatic Cancer with Gemcitabine + Nab-Paclitaxel |
| Date of disclosure of the study information | 2024/06/08 |
| Last modified on | 2024/12/08 17:02:24 |
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Basic information
Public title
Pharmacokinetics and Prediction of Adverse Effects by EOB-MRI in the Treatment of Pancreatic Cancer with Gemcitabine + Nab-Paclitaxel
Acronym
PK and Prediction of AE by EOB-MRI in the Treatment of Pancreatic Cancer with GnP
Scientific Title
Pharmacokinetics and Prediction of Adverse Effects by EOB-MRI in the Treatment of Pancreatic Cancer with Gemcitabine + Nab-Paclitaxel
Scientific Title:Acronym
PK and Prediction of AE by EOB-MRI in the Treatment of Pancreatic Cancer with GnP
Region
| Japan |
Condition
Condition
Pancreatic cancer treated with GEM + nab PTX
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to measure the blood concentration of nab-PTX in GnP therapy for pancreatic cancer and to develop a blood concentration model that can determine the optimal range of blood concentration and dosage by examining the efficacy and occurrence of adverse events. In addition, EOB-MRI, which reflects the function of OATP1B1/3, and its gene polymorphisms will be measured and used as covariates in the blood concentration model together with other clinical data such as age, gender, liver function, and renal function, to create a practical model for application to personalized medicine.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CIPN events
Key secondary outcomes
OS,ORR,PFS,AEs
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
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 over 18 years old
2 Pathological diagnosis of pancreatic cancer
3 Treat with GnP
4 Alive more than 3months
5 obtain informed consent
Key exclusion criteria
1 Inability to perform contrast-enhanced CT or MRI due to renal dysfunction
2 Inability to undergo MRI examination due to claustrophobia
3 Already receiving treatment for peripheral neuropathy
4 Pregnant
5 Other subjects deemed inappropriate as research subjects by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Isayama |
Organization
Juntendo Univ.
Division name
dept of Gastroenterology
Zip code
113-8421
Address
2-1-1, Hongo Bunkyo-ku Tokyo
TEL
03-3813-3111
h-isayama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Takasaki |
Organization
Juntendo Univ.
Division name
dept of Gastroenterology
Zip code
113-8421
Address
2-1-1, Hongo Bunkyo-ku Tokyo
TEL
03-3813-3111
Homepage URL
ytakasa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo Univ.
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (KAKEN)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JUNTENDO CLINICAL RESEARCH AND TRIAL CENTER
Address
3-1-3, Hongo Bunkyo-ku Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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
| 2024 | Year | 06 | Month | 08 | 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
| 2024 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
CIPN observation is done at 0.4.8.16 weeks and evaluated with EORTC-CIPN20 and NRS, PRO-CTCAE
Management information
Registered date
| 2024 | Year | 06 | Month | 08 | Day |
Last modified on
| 2024 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062394
