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A Study of E7090 in Participants With Unresectable Advanced or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor (FGFR) 2 Gene Fusion

Primary Purpose

Cholangiocarcinoma

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
E7090
Sponsored by
Eisai Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring E7090, Cholangiocarcinoma, Unresectable cholangiocarcinoma, Metastatic cholangiocarcinoma, Fibroblast Growth Factor Receptor 2 (FGFR2), FGFR2 gene fusion

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants with a histologically or cytologically diagnosis of intrahepatic or perihilar cholangiocarcinoma who agree to provide archival tumor sample or residual biopsy sample, or agree with tumor biopsy.
  2. Participants who have confirmed FGFR2 gene fusion of tumor by fluorescence in situ hybridization (FISH) in central laboratory. FGFR2 gene fusion confirmed by the same FISH assay in another test/study will be discussed with the sponsor and agreed on a case by case basis.
  3. Participants with surgically unresectable or advanced/metastatic disease who have received at least one prior chemotherapy including gemcitabine-based combination chemotherapy (example: gemcitabine and cisplatin)

    a. Prior adjuvant chemotherapy is allowed if relapse was within 6 months after last administration.

  4. Measurable disease meeting the following criteria:

    1. At least 1 lesion of >=1.0 centimeter (cm) in the longest diameter for a non-lymph node or >=1.5 cm in the short-axis diameter for a lymph node that is serially measurable according to RECIST 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI).
    2. Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.
  5. Corrected serum calcium less than or equal to (<=) upper limit of normal (ULN).
  6. Phosphate <=ULN.
  7. Participants with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG).
  8. Participants who are expected to survive for 3 months or longer after starting administration of the investigational drug.
  9. Washout period required from the end of prior treatment to the start of E7090 administration will be as follows

    1. Antibody and other investigational drugs : >=4 weeks
    2. Prior chemotherapy (except small-molecule targeted therapy), surgical therapy, radiation therapy:>=3 weeks
    3. Endocrine therapy, immunotherapy, small-molecule targeted therapy: >=2 weeks

Exclusion Criteria:

  1. Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (example: radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
  2. Concomitant active infection requiring systemic treatment (except hepatitis B or C virus-infected participants who are under anti-viral treatment).
  3. Participants who test positive for human immunodeficiency virus (HIV antibody) at Screening 2.
  4. Child-Pugh score B or C.
  5. Moderate or severe ascites extending from the pelvis to the liver surface.
  6. Following ocular disorders

    1. Current evidence of Grade 2 or higher corneal disorder
    2. Current evidence of active macula disorder (example: age-related macular degeneration, central serous chorioretinal disease)
  7. Participants whose toxicity of previous treatment has not recovered to Grade 1 or lower per Common Terminology Criteria for Adverse Events (CTCAE v4.03), except for alopecia, infertility and the adverse events listed in inclusion criteria.
  8. Participants with prior therapy targeting FGFR2.
  9. Participants who need the use of drugs or foods that strongly inhibits or induces the metabolizing enzyme cytochrome P450 (CYP) 3A4 during study treatment (there must be a time interval of >= 7 days since the final use of these drugs or foods by the start of study treatment).

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical College
  • Anhui Provincial Hospital
  • Beijing Tsinghua Chang Gung Memorial Hospital
  • Beijing Youan Hospital Affiliated to Capital Medical University
  • Beijng Cancer Hospital
  • Cancer Hospital Chinese Academy of Medical Sciences
  • Peking Union Medical University Hospital
  • Fujian Provincial Hospital
  • The First Affiliated Hospital of Xiamen University
  • Guangdong Province Traditional Chinese Medical Hospital
  • The First Affiliated Hospital, Sun Yat-sen Univeristy
  • Peking University Shenzhen Hospital
  • Affiliated Hospital of Hebei University
  • Affilicataed Cancer Hospital of Harbin Medical University
  • Henan Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
  • Hunan provincial people's hospital
  • The Third Xiangya Hospital of Central South University
  • Xiangya Hospital of Central South University
  • Jiangsu Province Hospital
  • Nantong Tumor Hospital
  • The First Affiliated Hospital of Soochow
  • Jilin Cancer Hospital
  • Shandong Cancer Hospital
  • Fudan University Shanghai Cancer Center
  • Zhongshan Hospital Fudan University
  • West China Hospital of Sichuan University
  • The First Affiliated Hospital, College of Medicine, Zhejiang University
  • The Second Affiliated Hospital, Zhejiang University School of Medicine
  • Ningbo First Hospital
  • Eisai Trial Site 10
  • Eisai Trial Site 16
  • Eisai Trial Site 11
  • Eisai Trial Site 14
  • Eisai Trial Site 2
  • Eisai Trial Site 8
  • Eisai Trial Site 7
  • Eisai Trial Site 23
  • Eisai Trial Site 22
  • Eisai Trial Site 13
  • Eisai Trial Site 17
  • Eisai Trial Site 9
  • Eisai Trial Site 5
  • Eisai Trial Site 4
  • Eisai Trial Site 6
  • Eisai Trial Site 3
  • Eisai Trial Site 1
  • Eisai Trial Site 18
  • Eisai Trial Site 15
  • Eisai Trial Site 20
  • Eisai Trial Site 19
  • Eisai Trial Site 12
  • Eisai Trial Site 21
  • Eisai Trial Site 24

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

E7090 140 mg

Arm Description

Participants will receive E7090 140 mg (milligram), tablets orally once daily (QD), in 28-days treatment cycle until disease progression, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination.

Outcomes

Primary Outcome Measures

ORR
The ORR will be assessed by IIR based on RECIST version 1.1. ORR is defined as a percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). CR: disappearance of all (targeted and non-target [NT]) lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to (>=) 30 percent (%) decrease in sum of diameters of target lesions taking as reference baseline, associated to non-progressive disease (non-PD) response for (NT) lesions.

Secondary Outcome Measures

Progression Free Survival (PFS)
PFS will be assessed by IIR based on RECIST version 1.1. PFS is defined as the time from the date of first dose to the date of first documentation of progressive disease (PD) or date of death from any cause, whichever occurs first. PD per RECIST 1.1 is defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.
Duration of Response (DOR)
DOR will be assessed by IIR based on RECIST version 1.1. DOR is defined as the time from the date of first documentation of CR or PR to the date of first documentation of disease progression or date of death from any cause, whichever occurs first. CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions.
Time to Response (TTR)
TTR will be assessed by IIR based on RECIST version 1.1. TTR is defined as the time from the date of first study dose to the date of first documentation of CR or PR. CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions.
Overall Survival (OS)
OS is defined as the time from the date of first dose to the date of death from any cause. For the participants who are alive or unknown, OS is censored as the date of last known alive date.
Disease Control Rate (DCR)
DCR will be assessed by IIR based on RECIST version 1.1. DCR is defined as a percentage of participants with BOR of CR, PR or stable disease (SD). The BOR of SD has to be observed greater than or equal to (>=) 7 weeks from the date of first study dose. CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions.
Clinical Benefit Rate (CBR)
CBR will be assessed by IIR based on RECIST version 1.1. CBR is defined as a percentage of participants with BOR of CR, PR or durable SD (dSD) (duration of SD >=23 weeks). CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions.

Full Information

First Posted
January 22, 2020
Last Updated
September 4, 2023
Sponsor
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04238715
Brief Title
A Study of E7090 in Participants With Unresectable Advanced or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor (FGFR) 2 Gene Fusion
Official Title
A Multicenter, Open-Label, Phase 2 Trial of E7090 in Subjects With Unresectable Advanced or Metastatic Cholangiocarcinoma With FGFR 2 Gene Fusion
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
September 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of the study is to assess the objective response rate (ORR) of E7090 by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 based on independent imaging review (IIR) in participants with unresectable cholangiocarcinoma with FGFR2 gene fusion who failed gemcitabine-based combination chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma
Keywords
E7090, Cholangiocarcinoma, Unresectable cholangiocarcinoma, Metastatic cholangiocarcinoma, Fibroblast Growth Factor Receptor 2 (FGFR2), FGFR2 gene fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E7090 140 mg
Arm Type
Experimental
Arm Description
Participants will receive E7090 140 mg (milligram), tablets orally once daily (QD), in 28-days treatment cycle until disease progression, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination.
Intervention Type
Drug
Intervention Name(s)
E7090
Intervention Description
E7090 tablets orally.
Primary Outcome Measure Information:
Title
ORR
Description
The ORR will be assessed by IIR based on RECIST version 1.1. ORR is defined as a percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). CR: disappearance of all (targeted and non-target [NT]) lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to (>=) 30 percent (%) decrease in sum of diameters of target lesions taking as reference baseline, associated to non-progressive disease (non-PD) response for (NT) lesions.
Time Frame
From first dose of study drug until disease progression, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 2 years 11 months)
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS will be assessed by IIR based on RECIST version 1.1. PFS is defined as the time from the date of first dose to the date of first documentation of progressive disease (PD) or date of death from any cause, whichever occurs first. PD per RECIST 1.1 is defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.
Time Frame
From the date of first dose to the date of first documentation of disease progression or date of death from any cause, whichever occurs first (up to approximately 2 years 11 months)
Title
Duration of Response (DOR)
Description
DOR will be assessed by IIR based on RECIST version 1.1. DOR is defined as the time from the date of first documentation of CR or PR to the date of first documentation of disease progression or date of death from any cause, whichever occurs first. CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions.
Time Frame
From the date of first documentation of CR or PR to the date of first documentation of disease progression or date of death from any cause, whichever occurs first (up to approximately 2 years 11 months)
Title
Time to Response (TTR)
Description
TTR will be assessed by IIR based on RECIST version 1.1. TTR is defined as the time from the date of first study dose to the date of first documentation of CR or PR. CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions.
Time Frame
from the date of first study dose to the date of first documentation of CR or PR (up to approximately 2 years 11 months)
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of first dose to the date of death from any cause. For the participants who are alive or unknown, OS is censored as the date of last known alive date.
Time Frame
From the date of first dose to the date of death from any cause (up to approximately 2 years 11 months)
Title
Disease Control Rate (DCR)
Description
DCR will be assessed by IIR based on RECIST version 1.1. DCR is defined as a percentage of participants with BOR of CR, PR or stable disease (SD). The BOR of SD has to be observed greater than or equal to (>=) 7 weeks from the date of first study dose. CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions.
Time Frame
From first dose of study drug until disease progression, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 2 years 11 months)
Title
Clinical Benefit Rate (CBR)
Description
CBR will be assessed by IIR based on RECIST version 1.1. CBR is defined as a percentage of participants with BOR of CR, PR or durable SD (dSD) (duration of SD >=23 weeks). CR: disappearance of all lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to >=30% decrease in sum of diameters of target lesions taking as reference baseline, associated to non-PD response for NT lesions.
Time Frame
From first dose of study drug until disease progression, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 2 years 11 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with a histologically or cytologically diagnosis of intrahepatic or perihilar cholangiocarcinoma who agree to provide archival tumor sample or residual biopsy sample, or agree with tumor biopsy. Participants who have confirmed FGFR2 gene fusion of tumor by fluorescence in situ hybridization (FISH) in central laboratory. FGFR2 gene fusion confirmed by the same FISH assay in another test/study will be discussed with the sponsor and agreed on a case by case basis. Participants with surgically unresectable or advanced/metastatic disease who have received at least one prior chemotherapy including gemcitabine-based combination chemotherapy (example: gemcitabine and cisplatin) a. Prior adjuvant chemotherapy is allowed if relapse was within 6 months after last administration. Measurable disease meeting the following criteria: At least 1 lesion of >=1.0 centimeter (cm) in the longest diameter for a non-lymph node or >=1.5 cm in the short-axis diameter for a lymph node that is serially measurable according to RECIST 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI). Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion. Corrected serum calcium less than or equal to (<=) upper limit of normal (ULN). Phosphate <=ULN. Participants with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG). Participants who are expected to survive for 3 months or longer after starting administration of the investigational drug. Washout period required from the end of prior treatment to the start of E7090 administration will be as follows Antibody and other investigational drugs : >=4 weeks Prior chemotherapy (except small-molecule targeted therapy), surgical therapy, radiation therapy:>=3 weeks Endocrine therapy, immunotherapy, small-molecule targeted therapy: >=2 weeks Exclusion Criteria: Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (example: radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment. Concomitant active infection requiring systemic treatment (except hepatitis B or C virus-infected participants who are under anti-viral treatment). Participants who test positive for human immunodeficiency virus (HIV antibody) at Screening 2. Child-Pugh score B or C. Moderate or severe ascites extending from the pelvis to the liver surface. Following ocular disorders Current evidence of Grade 2 or higher corneal disorder Current evidence of active macula disorder (example: age-related macular degeneration, central serous chorioretinal disease) Participants whose toxicity of previous treatment has not recovered to Grade 1 or lower per Common Terminology Criteria for Adverse Events (CTCAE v4.03), except for alopecia, infertility and the adverse events listed in inclusion criteria. Participants with prior therapy targeting FGFR2. Participants who need the use of drugs or foods that strongly inhibits or induces the metabolizing enzyme cytochrome P450 (CYP) 3A4 during study treatment (there must be a time interval of >= 7 days since the final use of these drugs or foods by the start of study treatment).
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Beijing Tsinghua Chang Gung Memorial Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Youan Hospital Affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijng Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking Union Medical University Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Fujian Provincial Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
Guangdong Province Traditional Chinese Medical Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen Univeristy
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
State/Province
Hebei
Country
China
Facility Name
Affilicataed Cancer Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Hunan provincial people's hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Nantong Tumor Hospital
City
Nantong
State/Province
Jiangsu
Country
China
Facility Name
The First Affiliated Hospital of Soochow
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
The First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Facility Name
Eisai Trial Site 10
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Eisai Trial Site 16
City
Kashiwa
State/Province
Chiba
Country
Japan
Facility Name
Eisai Trial Site 11
City
Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
Eisai Trial Site 14
City
Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
Eisai Trial Site 2
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Eisai Trial Site 8
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Eisai Trial Site 7
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Eisai Trial Site 23
City
Tsu
State/Province
Mie
Country
Japan
Facility Name
Eisai Trial Site 22
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Eisai Trial Site 13
City
Hirakata
State/Province
Osaka
Country
Japan
Facility Name
Eisai Trial Site 17
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Eisai Trial Site 9
City
Sunto-gun
State/Province
Shizuoka
Country
Japan
Facility Name
Eisai Trial Site 5
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trial Site 4
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trial Site 6
City
Koto-ku
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trial Site 3
City
Mitaka
State/Province
Tokyo
Country
Japan
Facility Name
Eisai Trial Site 1
City
Ube-Shi
State/Province
Yamaguchi
Country
Japan
Facility Name
Eisai Trial Site 18
City
Chiba
Country
Japan
Facility Name
Eisai Trial Site 15
City
Fukuoka
Country
Japan
Facility Name
Eisai Trial Site 20
City
Kagoshima
Country
Japan
Facility Name
Eisai Trial Site 19
City
Kochi
Country
Japan
Facility Name
Eisai Trial Site 12
City
Kyoto
Country
Japan
Facility Name
Eisai Trial Site 21
City
Niigata
Country
Japan
Facility Name
Eisai Trial Site 24
City
Wakayama
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Learn more about this trial

A Study of E7090 in Participants With Unresectable Advanced or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor (FGFR) 2 Gene Fusion

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