NCT04238715|CompletedPhase 2

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

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

Eisai Co., Ltd.ClinicalTrials.gov

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1 other identifier

E7090-J000-201

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredJan 2020

StartedJan 2020

CompletionNov 2025

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jan 2020

Longer than P75 for phase_2

Geographic Reach

2 countries

56 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.8 years study duration

First Submitted

Initial submission to the registry

January 22, 2020

Completed

Same day until next milestone

Study Start

First participant enrolled

January 22, 2020

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed

5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2025

Completed

Last Updated

March 2, 2026

Status Verified

February 1, 2025

Enrollment Period

5.8 years

First QC Date

January 22, 2020

Last Update Submit

February 27, 2026

Conditions

Cholangiocarcinoma

Keywords

E7090CholangiocarcinomaUnresectable cholangiocarcinomaMetastatic cholangiocarcinomaFibroblast Growth Factor Receptor 2 (FGFR2)FGFR2 gene fusion

Outcome Measures

Primary Outcomes (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.
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)

Progression Free Survival (PFS)
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)
Duration of Response (DOR)
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)
Time to Response (TTR)
from the date of first study dose to the date of first documentation of CR or PR (up to approximately 6 years 2 months)
Overall Survival (OS)
From the date of first dose to the date of death from any cause (up to approximately 6 years 2 months)
Disease Control Rate (DCR)
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)
+1 more secondary outcomes

Study Arms (1)

E7090 140 mg

EXPERIMENTAL

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.

Drug: E7090

Interventions

E7090DRUG

E7090 tablets orally.

E7090 140 mg

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eisai Co., Ltd.lead

Study Sites (56)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

Anhui Provincial Hospital

Hefei, Anhui, China

Location

Beijing Tsinghua Chang Gung Memorial Hospital