UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056810 |
|---|---|
| Receipt number | R000064929 |
| Scientific Title | An Observational Study Evaluating Clinicopathological Features of Patients with FGFR2b Positive Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma(WJOG18524GPS) |
| Date of disclosure of the study information | 2025/01/27 |
| Last modified on | 2025/11/13 10:06:28 |
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Basic information
Public title
An Observational Study Evaluating Clinicopathological Features of Patients with FGFR2b Positive Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma(WJOG18524GPS)
Acronym
FIREBIRD Study
Scientific Title
An Observational Study Evaluating Clinicopathological Features of Patients with FGFR2b Positive Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma(WJOG18524GPS)
Scientific Title:Acronym
FIREBIRD Study
Region
| Japan |
Condition
Condition
FGFR2b positive unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma, the frequency of positive cases diagnosed by immunohistochemistry (IHC) using the VENTANA FGFR2b assay will be determined to investigate the clinicopathological characteristics of FGFR2b-positive gastric cancer.
Basic objectives2
Others
Basic objectives -Others
In unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma, the frequency of positive cases diagnosed by immunohistochemistry (IHC) using the VENTANA FGFR2b assay will be determined to investigate the clinicopathological characteristics of FGFR2b-positive gastric cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the proportion of FGFR2b-positive cases of unresectable advanced or recurrent gastric cancer
Key secondary outcomes
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
1)Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
2)Diagnosed with unresectable advanced or recurrent disease.
3)Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0?2.
4)Presence of evaluable lesions (measurable lesions are not required).
5)The primary disease meets one of the following conditions:
(a)Scheduled for first-line treatment including fluoropyrimidine-based agents.
(b)Currently undergoing first-line treatment including fluoropyrimidine-based agents.
(c)Determined to be unresponsive (including clinical progression as judged by the attending physician) or intolerant to first-line treatment including fluoropyrimidine-based agents, but has not begun second-line treatment.
6)Submission of preserved tumor tissue samples collected within 2 years prior to obtaining consent (the same date up to 2 years before collection date) or submission of newly collected tumor biopsy specimens is feasible.
7)Adequate explanation of the protocol has been provided to the patient prior to enrollment, and written consent has been obtained from the patient.
Key exclusion criteria
1) Active double cancer requiring active treatment such as chemotherapy or surgery (synchronous or metachronous double cancer with a disease-free period of 3 years). Exceptions include cases where the risk of metastasis or death is negligible and cure is expected with local treatment (e.g., appropriately treated cervical intraepithelial neoplasia, basal cell carcinoma, cutaneous squamous cell carcinoma, localized prostate cancer treated with curative intent, ductal carcinoma treated in situ with curative intent).
2) History of taxane-based agent administration (including neoadjuvant or adjuvant chemotherapy).
3) History of FGF-FGFR pathway or VEGF-VEGFR pathway inhibitor administration.
4) Cases deemed inappropriate for enrollment by the attending physician.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kenro |
| Middle name | |
| Last name | Hirata |
Organization
Keio University School of Medicine
Division name
Cancer center
Zip code
160-8582
Address
5 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3288
kenro@keio.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ishizuka |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Amgen K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2025 | Year | 01 | Month | 27 | 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
Suspended
Date of protocol fixation
| 2024 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The primary endpoint will be the proportion of FGFR2b-positive cases (patients with >=10% of tumor cells showing FGFR2b membranous staining at 3+ or 2+ intensity). FGFR2b-positive patients with unresectable advanced or recurrent gastric cancer will be eligible for enrollment in the ongoing "AC18524G: Phase II Trial of Bemarituzumab + Paclitaxel plus Ramucirumab in FGFR2b-positive Unresectable, Advanced or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma."
Management information
Registered date
| 2025 | Year | 01 | Month | 24 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064929
