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CholangiocarcinomaPhase 2NCT04238715

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

A Phase 2 study testing E7090 in people with Cholangiocarcinoma, run by Eisai Co., Ltd. at 56 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Cholangiocarcinoma
What is being tested?
E7090
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
56 sitesin 2 countries
Study dates
22 Jan 2020to 3 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • 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).
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  • 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

Who cannot join

  • 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
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  • 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).

Trial locations and contacts

56 sites in 2 countries.

56 sites in 2 countries

China32 sites

  • Affiliated Hospital of Hebei University

    Baoding, Hebei

  • Beijing Tsinghua Chang Gung Memorial Hospital

    Beijing, Beijing Municipality

  • Beijing Youan Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality

  • Beijng Cancer Hospital

    Beijing, Beijing Municipality

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

  • Peking Union Medical University Hospital

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

  • Jilin Cancer Hospital

    Changchun, Jilin

  • Hunan provincial people's hospital

    Changsha, Hunan

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital of Central South University

    Changsha, Hunan

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • Fujian Provincial Hospital

    Fuzhou, Fujian

  • Guangdong Province Traditional Chinese Medical Hospital

    Guangzhou, Guangdong

  • The First Affiliated Hospital, Sun Yat-sen Univeristy

    Guangzhou, Guangdong

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Affilicataed Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Anhui Provincial Hospital

    Hefei, Anhui

  • Shandong Cancer Hospital

    Jinan, Shandong

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Nantong Tumor Hospital

    Nantong, Jiangsu

  • Ningbo First Hospital

    Ningbo, Zhejiang

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong

  • The First Affiliated Hospital of Soochow

    Suzhou, Jiangsu

  • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

Japan24 sites

  • Eisai Trial Site 5

    Bunkyo-ku, Tokyo

  • Eisai Trial Site 18

    Chiba

  • Eisai Trial Site 4

    Chuo-ku, Tokyo

  • Eisai Trial Site 15

    Fukuoka

  • Eisai Trial Site 13

    Hirakata, Osaka

  • Eisai Trial Site 20

    Kagoshima

  • Eisai Trial Site 8

    Kanazawa, Ishikawa-ken

  • Eisai Trial Site 16

    Kashiwa, Chiba

  • Eisai Trial Site 19

    Kochi

  • Eisai Trial Site 6

    Koto-ku, Tokyo

  • Eisai Trial Site 12

    Kyoto

  • Eisai Trial Site 11

    Matsuyama, Ehime

  • Eisai Trial Site 14

    Matsuyama, Ehime

  • Eisai Trial Site 3

    Mitaka, Tokyo

  • Eisai Trial Site 10

    Nagoya, Aichi-ken

  • Eisai Trial Site 21

    Niigata

  • Eisai Trial Site 2

    Sapporo, Hokkaido

  • Eisai Trial Site 22

    Sendai, Miyagi

  • Eisai Trial Site 17

    Suita, Osaka

  • Eisai Trial Site 9

    Sunto-gun, Shizuoka

  • Eisai Trial Site 23

    Tsu, Mie-ken

  • Eisai Trial Site 1

    Ube-Shi, Yamaguchi

  • Eisai Trial Site 24

    Wakayama

  • Eisai Trial Site 7

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Multicenter, Open-Label, Phase 2 Trial of E7090 in Subjects With Unresectable Advanced or Metastatic Cholangiocarcinoma With FGFR 2 Gene Fusion

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.

Being tested
E7090
Keywords
E7090, Cholangiocarcinoma, Unresectable cholangiocarcinoma, Metastatic cholangiocarcinoma, Fibroblast Growth Factor Receptor 2 (FGFR2), FGFR2 gene fusion
Medical subject headings
Cholangiocarcinoma, Acrocephalosyndactylia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E7090Drug

    E7090 tablets orally.

Study groups in NCT04238715
Study groupRoleWhat they receive
E7090 140 mgExperimentalParticipants 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.
Receives: Drug: E7090

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 6 years 2 months)

Secondary outcomes (6)

  1. 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.

    Measured: 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 6 years 2 months)

  2. 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.

    Measured: 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 6 years 2 months)

  3. 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.

    Measured: from the date of first study dose to the date of first documentation of CR or PR (up to approximately 6 years 2 months)

  4. 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.

    Measured: From the date of first dose to the date of death from any cause (up to approximately 6 years 2 months)

  5. 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.

    Measured: 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 6 years 2 months)

  6. 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.

    Measured: 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 6 years 2 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2020
  2. Study start22 Jan 2020
  3. Primary completion3 Nov 2025
  4. Study completion3 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04238715
Sponsor's protocol ID
E7090-J000-201
Status last verified
Feb 2025
First submitted
22 Jan 2020
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E7090 in people with Cholangiocarcinoma, run by Eisai Co., Ltd. at 56 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in China, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (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 6 years 2 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04238715.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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