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TumorsPhase 1NCT02275910

Phase 1 Study of E7090 in Subjects With Solid Tumor

A Phase 1 study testing E7090 in people with Tumors, run by Eisai Co., Ltd. at 18 sites in Japan.

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

This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be conducted in 2 parts: 1. Part 1 will be the dose escalation portion of this study to determine the maximum tolerated dose in subjects with solid tumors, and 2. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Tumors
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
40 participants
Where
18 sitesJapan
Study dates
28 Oct 2014to 3 Sep 2021
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Provide written informed consent
  • Male or female subjects age >= 20 years at the time of informed consent
  • Subjects with a histological and/or cytological diagnosis of solid tumor
  • Subjects who failed standard therapies, or for which no appropriate treatment is available.
  • Subjects with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG)
  • Subjects who are expected to survive for 3 months or longer after starting administration of the investigational drug.
  • Subjects with tumor expressing genetic abnormality in FGF/FGFR (fibroblast growth factor/ fibroblast growth factor receptor)pathway.

Who cannot join

  • Patients with brain metastasis who have clinical symptoms or requiring treatment.
  • Medical history of clinically significant cardiovascular impairment
  • Concomitant systemic infection requiring medical treatment
  • Effusion requiring drainage
  • Known intolerance to the study drug (or any of excipients)
  • Subjects whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia).
Show all 10Show fewer
  • Inability to take oral medication, or malabsorption syndrome, or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of E7090.
  • Psychiatric disorder (e.g., alcohol or drug dependency) judged to be ineligible for study entry by the investigator or subinvestigator
  • Females who are pregnant or breastfeeding
  • Any subjects who are judged by the principal investigator or the other investigators to be inappropriate as subjects in this clinical study.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Japan18 sites

  • Eisai Trial Site #1

    Amagasaki, Hyōgo

  • Eisai Trial Site #1

    Chiba

  • Eisai Trial Site #1

    Chuo-ku, Niigata

  • Eisai Trial Site #1

    Chuo-Ku, Tokyo

  • Eisai Trial Site #1

    Fukuoka

  • Eisai Trial Site #1

    Kashiwa, Chiba

  • Eisai Trial Site #1

    Kawasaki, Kanagawa

  • Eisai Trial Site #1

    Kitaadachi, Saitama

  • Eisai Trial Site #1

    Koto-ku, Tokyo

  • Eisai Trial Site #1

    Kyoto

  • Eisai Trial Site #1

    Matsuyama, Ehime

  • Eisai Trial Site #1

    Nagoya, Aichi-ken

  • Eisai Trial Site #1

    Osaka

  • Eisai Trial Site #2

    Osaka

  • Eisai Trial Site #3

    Osaka

  • Eisai Trial Site #1

    Sapporo, Hokkaido

  • Eisai Trial Site #1

    Tsukuba, Ibaraki

  • Eisai Trial Site #1

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Phase 1 Study of E7090 in Subjects With Solid Tumor

This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be conducted in 2 parts:

  1. Part 1 will be the dose escalation portion of this study to determine the maximum tolerated dose in subjects with solid tumors, and
  2. Part 2 will comprise cohort expansions to further characterize the safety and tolerability of E7090 and to assess preliminary efficacy of E7090 in subjects with solid tumors characterized by genetic abnormalities in FGF/FGFR pathway.
Conditions
Tumors
Being tested
E7090
Keywords
Solid Tumors, E7090
Medical subject headings
Neoplasms

What participants receive

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

  • E7090Drug

Study groups in NCT02275910
Study groupRoleWhat they receive
E7090 ArmExperimentalOral, starting dose 1 mg once a day, dose escalation in part 1. Cycle 0 is for 7 days. For Cycle 1 and onward, each cycle is 28 days long. The Cycle 0 is set up for PK analysis of a single dose of E7090. In the following Cycle 1, subjects will be administered E7090 QD, and the PK and safety will be assessed for 28 days. One or two doses may be selected from part 1 for Part 2. E7090 will be administered continuously once a daily. Subjects can continue treatment unless they meet discontinuation criteria.
Receives: Drug: E7090

What is being measured

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

  1. Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)

    DLT was graded using Common Terminology Criteria for Adverse Events version 4.03 as follows: a. febrile neutropenia, or Grade 4 neutropenia persisting for greater than or equal to (>=) 7 days, b. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia requiring platelet transfusions, c. Grade >=3 non-hematological toxicity, except for: clinically insignificant laboratory abnormalities, toxicity Grade less than or equal to (<=) 2 by best supportive care; d. potentially clinically significant, new radiographic mineralization in soft tissue, kidneys, intestines, heart, lungs, or other organs; e. Hyperphosphatemia meeting either for: serum phosphate level greater than (>) 7 milligram per deciliter (mg/dL) persisting for >=7 days despite best treatment, serum phosphate level >9 mg/dL despite best treatment; f. treatment interruption for >=8 days during Cycle 0; Cycle 1 required by E7090-related toxicity, except for treatment interruption for >=8 days for reasons other than toxicity.

    Measured: Cycle 0 (Cycle length= 7 days) up to Cycle 1 (Cycle length= 28 days)

  2. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    A TEAE was defined as an adverse event (AE) that emerged during the time from the first dose of study drug to 30 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. A Serious AE is any untoward medical occurrence that at any dose: resulted in death; was life threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.

    Measured: From the start of study drug administration up to 2 year 9 months

Secondary outcomes (10)

  1. Part 2: Overall Survival (OS)

    OS was defined as the time from the date of first dose to the date of death from any cause. OS was estimated by using Kaplan-Meier method.

    Measured: From the date of first dose of study drug up to 2 years and 8 months

  2. Part 2: Progression- Free Survival (PFS)

    PFS was defined as the time from the date of first dose to the first documented date of event (disease progression or death from any cause, whichever occurs first). PD was defined as at least a 20 percent (%) increase in the sum of LD of target and non-target lesions as compared with the smallest sum of long diameter (LD) and the increase of LD was at least 5 millimeter (mm) (including new lesions). The tumor assessment is based on Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and was estimated using Kaplan-Meier method.

    Measured: From the date of first dose of study drug up to 2 years and 8 months

  3. Best Overall Response (BOR)

    Tumor assessment (target lesion, non-target lesion, and presence or absence of new lesion) was performed based on RECIST v1.1. Tumor marker was also measured. FDG-PET CT (fluorodeoxyglucose- Positron emission tomography computed tomography) also evaluated. Best overall responses were complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE). CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at >=7 weeks after first dose.

    Measured: From the date of first dose of study drug up to 2 years and 8 months

  4. Part 2: Objective Response Rate (ORR)

    ORR was defined as a percentage of participants with BOR of CR or PR. ORR was assessed using RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD.

    Measured: From screening up to 2 years and 8 months

  5. Part 2: Disease Control Rate (DCR)

    DCR was defined as the percentage of participants with BOR of CR, PR or SD. DCR was assessed based on RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with Baseline summed LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at >= 7 weeks after first dose.

    Measured: From the date of first dose of study drug up to 2 years and 8 months

  6. Cmax: Maximum Observed Plasma Concentration for E7090

    Measured: Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose; (Cycle 1 is 28 days)

  7. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090

    Measured: Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose; (Cycle 1 is 28 days)

  8. AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours

    Measured: Part 1: Cycle 0 Day 1: 0-24 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose (Cycle 1 is 28 days)

  9. Part 1: CL/F: Apparent Total Clearance for E7090

    Measured: Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days)

  10. All Percent Change From Baseline Tumor Shrinkage

    Tumor assessments were performed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. For each participant, the sum of the longest diameters (SLD) of target lesions was calculated at baseline and at each post-baseline assessment. Percent change from baseline tumor burden was then calculated. Multiple target lesions within a participant were combined using the RECIST v1.1 methodology to derive a single tumor burden value. The reported value represented the percent change from baseline in tumor burden for each participant based on post-baseline tumor assessments. This outcome measure was analyzed at the participant level.

    Measured: From screening up to 2 years and 8 months

Timeline

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

  1. First posted27 Oct 2014 (estimated)
  2. Study start28 Oct 2014
  3. Primary completion3 Sep 2021
  4. Study completion3 Sep 2021

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02275910
Sponsor's protocol ID
E7090-J081-101
Status last verified
Sep 2026
First submitted
20 Oct 2014
Last updated
21 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E7090 in people with Tumors, run by Eisai Co., Ltd. at 18 sites in Japan.

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 7 inclusion and 10 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) (time frame: Cycle 0 (Cycle length= 7 days) up to Cycle 1 (Cycle length= 28 days)). The study lists 2 primary outcomes in all. 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 NCT02275910.

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 21 Oct 2026.

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