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Targeted drug shows promise for rare bile duct cancer

NCT ID NCT04238715

Disease control Sponsor: Eisai Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called E7090 in 63 people with advanced bile duct cancer that has a specific genetic change (FGFR2 fusion). Participants had already tried chemotherapy without success. The goal was to see if the drug could shrink tumors. Results help determine if this targeted therapy offers a new treatment option for this hard-to-treat cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

63 people

The number who actually took part.

Started

Jan 2020

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Apert syndrome cholangiocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cholangiocarcinoma

Contacts and locations

Locations

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, China

  • Affilicataed Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang, China

  • Anhui Provincial Hospital

    Hefei, Anhui, China

  • Beijing Tsinghua Chang Gung Memorial Hospital

    Beijing, Beijing Municipality, China

  • Beijing Youan Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality, China

  • Beijng Cancer Hospital

    Beijing, Beijing Municipality, China

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, China

  • Eisai Trial Site 1

    Ube-Shi, Yamaguchi, Japan

  • Eisai Trial Site 10

    Nagoya, Aichi-ken, Japan

  • Eisai Trial Site 11

    Matsuyama, Ehime, Japan

  • Eisai Trial Site 12

    Kyoto, Japan

  • Eisai Trial Site 13

    Hirakata, Osaka, Japan

  • Eisai Trial Site 14

    Matsuyama, Ehime, Japan

  • Eisai Trial Site 15

    Fukuoka, Japan

  • Eisai Trial Site 16

    Kashiwa, Chiba, Japan

  • Eisai Trial Site 17

    Suita, Osaka, Japan

  • Eisai Trial Site 18

    Chiba, Japan

  • Eisai Trial Site 19

    Kochi, Japan

  • Eisai Trial Site 2

    Sapporo, Hokkaido, Japan

  • Eisai Trial Site 20

    Kagoshima, Japan

  • Eisai Trial Site 21

    Niigata, Japan

  • Eisai Trial Site 22

    Sendai, Miyagi, Japan

  • Eisai Trial Site 23

    Tsu, Mie-ken, Japan

  • Eisai Trial Site 24

    Wakayama, Japan

  • Eisai Trial Site 3

    Mitaka, Tokyo, Japan

  • Eisai Trial Site 4

    Chuo-ku, Tokyo, Japan

  • Eisai Trial Site 5

    Bunkyo-ku, Tokyo, Japan

  • Eisai Trial Site 6

    Koto-ku, Tokyo, Japan

  • Eisai Trial Site 7

    Yokohama, Kanagawa, Japan

  • Eisai Trial Site 8

    Kanazawa, Ishikawa-ken, Japan

  • Eisai Trial Site 9

    Sunto-gun, Shizuoka, Japan

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, China

  • Fujian Provincial Hospital

    Fuzhou, Fujian, China

  • Guangdong Province Traditional Chinese Medical Hospital

    Guangzhou, Guangdong, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, China

  • Hunan provincial people's hospital

    Changsha, Hunan, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, China

  • Jilin Cancer Hospital

    Changchun, Jilin, China

  • Nantong Tumor Hospital

    Nantong, Jiangsu, China

  • Ningbo First Hospital

    Ningbo, Zhejiang, China

  • Peking Union Medical University Hospital

    Beijing, Beijing Municipality, China

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, China

  • Shandong Cancer Hospital

    Jinan, Shandong, China

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, China

  • The First Affiliated Hospital of Soochow

    Suzhou, Jiangsu, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, China

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

    Hangzhou, Zhejiang, China

  • The First Affiliated Hospital, Sun Yat-sen Univeristy

    Guangzhou, Guangdong, China

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, China

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

    Wuhan, Hubei, China

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

    Wuhan, Hubei, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.