UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053840 |
|---|---|
| Receipt number | R000061445 |
| Scientific Title | Real-world data analysis of pemigatinib therapy for unresectable or recurrent biliary tract cancer patients with FGFR2 fusion or FGFR2 rearrangement |
| Date of disclosure of the study information | 2024/03/14 |
| Last modified on | 2024/03/12 21:26:07 |
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Basic information
Public title
Real-world data analysis of pemigatinib therapy for unresectable or recurrent biliary tract cancer patients with FGFR2 fusion or FGFR2 rearrangement
Acronym
JON2303-B
Scientific Title
Real-world data analysis of pemigatinib therapy for unresectable or recurrent biliary tract cancer patients with FGFR2 fusion or FGFR2 rearrangement
Scientific Title:Acronym
JON2303-B
Region
| Japan |
Condition
Condition
Unresectable or recurrent biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objective of this research is to clarify the clinical efficacy of pemigatinib for unresectable biliary tract cancer. In addition, information on gene abnormalities in biliary tract cancer will be collected, including details of FGFR2 fusion genes and gene rearrangements in clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoints are pemigatinib objective response rate and overall survival for the FGFR treatment-naive population at 3 years after marketing and a final analysis at 4 years after marketing
Key secondary outcomes
Secondary endpoints include correlation of efficacy with clinicopathologic characteristics of the overall population, correlation of efficacy with comorbid genetic abnormalities, tolerability of pemigatinib, and efficacy in populations previously treated with other FGFR inhibitors.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who met all of the following criteria and were examined at a participating institution between June 1, 2021 and January 31, 2024.
1. Diagnosis of biliary tract cancer (Intrahepatic bile duct cancer, hilar bile duct cancer, distal bile duct cancer, gallbladder cancer, and duodenal papilla cancer)
by histology or cytology (class IV or V).
2. Patients with FGFR2 fusion gene or FGFR2 gene rearrangement positive biliary tract cancer who were initially prescribed pemigatinib as health insurance treatment after
June 1, 2021.
3. Over 18 years of age at the time of initial pemigatinib prescription.
Key exclusion criteria
i) Patients who received pemigatinib prior to the period of this observational study.
ii) Patients who have received chemotherapy for a malignancy other than biliary tract cancer within 12 months before the first prescription of pemigatinib.
iii) Patients who had a history of prescription of pemigatinib but could not confirm oral administration.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ioka |
Organization
Yamaguchi University Hospital
Division name
Cancer Center
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836222170
ioka_ta@hotmail.com
Public contact
Name of contact person
| 1st name | Yuuta |
| Middle name | |
| Last name | Kimura |
Organization
Yamaguchi University Hospital
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836222264
Homepage URL
ykimura@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-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
| 2024 | Year | 03 | Month | 14 | 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 | 02 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The enrollment period; From June 1, 2021 to January 31, 2024.
Subjects; Patients who met of the inclusion criteria and were examined at a participating institution in the enrollment period.
Collection item; Patient background factor, tumor factor, clinical examination findings, genomic information, treatment information, response, and prognosis.
Management information
Registered date
| 2024 | Year | 03 | Month | 12 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061445
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
