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Solid TumorsPhase 1NCT03444701

A Study of E7130 in Participants With Solid Tumors

A Phase 1 study testing E7130 in people with Solid Tumors, run by Eisai Co., Ltd. at 9 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this study is to evaluate the tolerability and safety profile of E7130 in participants with solid tumors. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Solid Tumors
What is being tested?
E7130
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
9 sitesJapan
Study dates
5 Feb 2018to 27 Dec 2024
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

  • Participants who have provided voluntary written consent for participation in this clinical study
  • Participants to whom the rules for complying with this clinical study have been adequately explained, and who intend to and can comply with these rules
  • Participants aged greater than or equal to (>=) 20 years at the time of informed consent
  • Participants with adequate function of major organs
  • Participants with Performance Status score of 0 to 1 established by the Eastern Cooperative Oncology Group (ECOG)
  • Participants who are expected to survive for 3 months or longer after starting administration of the investigational drug
Show all 11Show fewer
  • Washout period required from the end of prior treatment to the first administration of study drug
  • Participants who agree to submit blood samples prior and during study treatment for progressive disease (PD) markers.
  • 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 response evaluation criteria in solid tumours (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 to be deemed a target lesion.

Who cannot join

  • Medical history of clinically significant cardiovascular impairment
  • Serious concomitant systemic infection requiring medical treatment (including bacterial infection and fungal infection)
  • Participants who test positive for human immunodeficiency virus (HIV antibody)
  • Active viral hepatitis (B or C) as demonstrated by positive serology or requiring treatment hepatitis B surface antigen (HBsAg), anti-hepatitis B surface antibody (anti-HBs)/hepatitis B core antibody (HBcAb) and anti-hepatitis C virus (HCV) antibody test.
  • Effusion requiring drainage
  • Participants whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia and hemoglobin)
Show all 14Show fewer
  • Other active malignancy
  • Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] or human chorionic gonadotropin [hCG]).
  • Women of childbearing potential or men of impregnate potential who don't agree that both the participant and his/her partner will use a medically effective method for contraception during the study and after study drug discontinuation (male; 90 days, female; 60 days)
  • Known intolerance to the study drug or any of the excipients
  • Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in the study
  • Scheduled for surgery during the study
  • Diagnosed with meningeal carcinomatosis
  • Participants with brain or subdural metastases are not eligible.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Japan9 sites

  • Eisai Trial Site 7

    Bunkyo-ku, Tokyo

  • Eisai Trial Site 5

    Chuo-ku, Osaka

  • Eisai Trial Site 3

    Chuo-ku, Tokyo

  • Eisai Trial Site 1

    Kashiwa, Chiba

  • Eisai Trial Site 6

    Kashiwa, Chiba

  • Eisai Trial Site 2

    Koto-ku, Tokyo

  • Eisai Trial Site 9

    Nagoya, Aichi-ken

  • Eisai Trial Site 8

    Sapporo, Hokkaido

  • Eisai Trial Site 4

    Sendai, Miyagi

Other trials in Japan

About this study

Official title: A Phase 1 Study of E7130 in Subjects With Solid Tumor

The primary objective of this study is to evaluate the tolerability and safety profile of E7130 in participants with solid tumors.

Conditions
Solid Tumors
Being tested
E7130
Keywords
Solid tumors, Squamous cell carcinoma of the head and neck, Urothelial carcinoma
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma, Transitional Cell

What participants receive

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

  • E7130Drug

    Starting dose of 25 μg/m^2 on Day 1 and Day 15 of Cycle 1.

  • E7130Drug

    Starting dose is lower than one at which the first DLT was observed in the 2-week regimen administered on Day 1 of Cycle 1.

Study groups in NCT03444701
Study groupRoleWhat they receive
E7130 (2-Week Regimen)ExperimentalPart 1 (Cycle 1; 28 days): The first cohort of 3 participants will receive 25 micrograms per meters squared (μg/m^2) of E7130, on Day 1 and Day 15 as an intravenous infusion. If a drug-related Grade 2 or higher toxicity excluding clinically insignificant events is not observed in the initial cohort, dose-limiting toxicities (DLTs) will be evaluated in successive dose levels with single participants until such a toxicity is observed. Once the maximum tolerated dose (MTD) will be determined. Part 2: Participants with squamous cell carcinoma of the head and neck and urothelial carcinoma will be evaluated at the dose level determined in Part 1 in a 2-week or in a 3-week regimen based on the evaluations in Part 1.
Receives: Drug: E7130
E7130 (3-Week Regimen)ExperimentalPart 1 (Cycle 1; 21 days): On Day 1, participants will receive E7130 at (-1) a lower dose than the dose at which the first DLT was observed in the 2-week regimen. Once the MTD will be determined. Part 2: Participants with squamous cell carcinoma of the head and neck and urothelial carcinoma will be evaluated at the dose level determined in Part 1 in a 3-week or in a 2-week regimen based on the evaluations in Part 1.
Receives: Drug: E7130

What is being measured

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

  1. Part 1: Number of Participants Assigned to Every 2 Weeks Regimen With Dose-limiting Toxicities (DLTs)

    DLTs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. DLTs were defined as the following events that occurred in Cycle 1, for which a causal relationship with E7130 could not be ruled out: febrile neutropenia; Grade 4 neutropenia; Grade 4 thrombocytopenia; Grade 4 anemia or anemia requiring red blood cell transfusion; any Grade 3 non-hematologic toxicity, except for abnormal clinical laboratory values without clinical significance or events manageable and controllable to Grade 2 or less with maximal medical management; any Grade 4 non-hematologic toxicity.

    Measured: Cycle 1 (Cycle length=28 days)

  2. Part 1: Number of Participants Assigned to Every 3 Weeks Regimen With DLTs

    DLTs were graded according to the NCI CTCAE version 4.03. DLTs were defined as the following events that occurred in Cycle 1, for which a causal relationship with E7130 could not be ruled out: febrile neutropenia; Grade 4 neutropenia; Grade 4 thrombocytopenia; Grade 4 anemia or anemia requiring red blood cell transfusion; any Grade 3 non-hematologic toxicity, except for abnormal clinical laboratory values without clinical significance or events manageable and controllable to Grade 2 or less with maximal medical management; any Grade 4 non-hematologic toxicity.

    Measured: Cycle 1 (Cycle length=21 days)

  3. Part 1 and Part 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    TEAE was defined per NCI CTCAE version 4.03 as an adverse event that emerged up to 30 days after the participant's last dose, having been absent at pretreatment (baseline) or (omitted). An AE was defined as any untoward medical occurrence in a participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product.

    Measured: From start of the study up to 82.5 months

  4. Part 1 and Part 2: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Value (Hematology Parameters)

    Number of participants with abnormal laboratory values were assessed and reported. Laboratory evaluations included hematology parameters such as hemoglobin (gram/liter [g/L]), platelets (10^9/L), leukocytes (10^9/L), neutrophils (10^9/L), and lymphocytes (10^9/L) assessed for markedly abnormal low or high values. Treatment-emergent markedly abnormal laboratory value was defined as a postbaseline laboratory value with grade 3 or higher, and with a grade increase from baseline. Laboratory results were graded using CTCAE version 4.03. CTCAE grades 1 through 5, where grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life threatening), and grade 5 (death).

    Measured: From baseline up to 82.5 months

  5. Part 1 and Part 2: Change From Baseline in Arterial Oxygen Saturation

    Change from baseline in arterial oxygen saturation was reported.

    Measured: From baseline up to 82.5 months

  6. Part 1 and Part 2: Number of Participants With Any Clinically Significant 12-lead Electrocardiogram (ECG) Value

    12-lead ECGs were performed to assess cardiac parameters including QT interval corrected for heart rate (QTc), QTc using the Fridericia formula (QTcF). QTcF abnormalities were summarized for increases of greater than (>) 30 milliseconds (msec), >60 msec, and absolute QTcF values >450, >480, and >500 msec.

    Measured: From baseline up to 82.5 months

  7. Number of Participants by Worst Post Dose Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Score

    ECOG performance score was measured on 6 point scale to assess participant's performance status, where: Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; Grade 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled, cannot carry on any selfcare. Totally confined to bed or chair; Grade 5: Dead.

    Measured: From baseline up to 82.5 months

Secondary outcomes (16)

  1. Part 1: Maximum Tolerated Dose (MTD) of E7130

    A dose with the smallest difference between the target DLT rate of 25% and an estimate of DLT rate for each dose was defined as the MTD. DLTs were defined as the following events that occurred in Cycle 1 and Cycle 2, for which a causal relationship with E7130 could not be ruled out: febrile neutropenia; Grade 4 neutropenia; Grade 4 thrombocytopenia; Grade 4 anemia or anemia requiring red blood cell transfusion; any Grade 3 non-hematologic toxicity, except for abnormal clinical laboratory values without clinical significance or events manageable and controllable to Grade 2 or less with maximal medical management; any Grade 4 non-hematologic toxicity.

    Measured: Cycle 1 and 2 (56 days [Q2W regimen] [Cycle length = 28 days], 42 days [Q3W regimen] [Cycle length = 21 days])

  2. Part 1: Cmax: Maximum Observed Plasma Concentration for E7130

    Measured: Bi-weekly: Cycles 1-2 Day 1: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)

  3. Part1: Tmax: Time to Reach Cmax of E7130

    Tmax was defined as the time to reach maximum observed plasma concentration for E7130.

    Measured: Bi-weekly: Cycles 1-2 Day 1: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)

  4. Part 1: AUC 0-inf: Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time for E7130

    AUC(0-inf) was defined as the area under the plasma concentration-time curve from 0 time to infinity.

    Measured: Bi-weekly: Cycle 1 Day 1: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycle 1 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)

  5. Part 1: T1/2: Terminal Half-life of E7130

    Measured: Bi-weekly: Cycles 1-2 Day 1: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)

  6. Part 1: CL: Total Clearance of E7130

    Measured: Bi-weekly: Cycles 1-2 Day 1: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)

  7. Part 1: Vd: Volume of Distribution of E7130

    Measured: Bi-weekly: Cycles 1-2 Day 1: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)

  8. Part 1 and Part 2: Recommended Dose for Future Studies

    Measured: From start of the study up to 82.5 months

  9. Part 1 and Part 2: Number of Participants Achieving Best Overall Response (BOR)

    The BOR was based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. BOR was defined as complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE), where SD was achieved at >=5 weeks after the first dose. BOR of CR or PR in Part 1 of this study required no confirmation of the next response at >=4 weeks. Part 2 required confirmation. Complete response was defined as disappearance of all target lesions. All lymph nodes selected as target lesions had reduction in short axis to <10 millimeter (mm). Partial response was defined as at least a 30% decrease in the diameter sum of target lesions, taking as reference the baseline diameter sum. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taken as reference the smallest diameter sum while on study.

    Measured: Part 1 and 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 82.5 months)

  10. Part 1 and 2: Objective Response Rate (ORR)

    ORR was defined as the percentage of participants who achieved a best overall response of confirmed partial response (PR) or complete response (CR). CR was defined as disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) with reduction in short axis to less than <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Part 1 and 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 82.5 months)

  11. Part 1 and Part 2: Disease Control Rate (DCR)

    DCR was defined as the percentage of participants with BOR of CR, PR or SD.

    Measured: Part 1 and 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 82.5 months)

  12. Part 1 and Part 2: Clinical Benefit Rate (CBR)

    CBR was defined as the percentage of participants with BOR of CR, PR or durable SD (duration of SD >=23 weeks). Duration of SD was defined as the time from the date of first dose to the date of the first documentation of disease progression or death from any cause, whichever occurred first. It was calculated for participants whose BOR was SD.

    Measured: Part 1 and 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 82.5 months)

  13. 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 occurred first). PD based on RECIST v1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum diameters while on study.

    Measured: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 82.5 months)

  14. Part 2: Duration of Response (DoR)

    DOR was defined as the time from the first documented date of PR or CR to the first documented date of event (disease progression or death from any cause, whichever occurred first). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Here, "number analyzed" signifies participants who had CR or PR.

    Measured: Part 2: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 82.5 months)

  15. 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. For the participants who were alive or unknown, OS was censored as the date of last known alive date or the date of data cut off, whichever came first.

    Measured: From the first dose of study drug to the first date of documentation of PD or death, whichever occurred first (up to 82.5 months)

  16. Percent Change From Baseline in Sum of Diameters of Target Tumor Lesions

    Percent change from baseline in the sum of diameters of target lesions was reported. Tumor measurements were performed according to RECIST version 1.1, where the longest diameter was used for non-nodal lesions and the short-axis diameter was used for nodal lesions.

    Measured: From baseline up to 82.5 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 Feb 2018
  2. Study start5 Feb 2018
  3. Primary completion27 Dec 2024
  4. Study completion27 Dec 2024

Why it stopped: The trial was prematurely terminated due to the sponsor's decision.

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
Non-randomised
Intervention model
Sequential
Model description
This is a Phase 1 study of E7130 in participants with solid tumors. This study will be conducted in 2 parts (Part 1 and Part 2). Part 1 will be the dose escalation portion of this study, conducted to assess dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) in participants with solid tumors. The dosage and the duration of the treatment cycle in Part 2 will be determined based on the data from Part 1. Part 2 will be comprised of cohort expansions to further characterize the safety and tolerability of E7130.
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03444701
Sponsor's protocol ID
E7130-J081-101
Status last verified
Mar 2026
First submitted
4 Feb 2018
Last updated
23 Oct 2026
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Matsubara N, Saijo K, Shimizu Y, Okano S, Nakano K, Nishio N, Otsuka T, Kuno H, Miura T, Kubota T, Ikezawa H, Umetsu Y, Ito K, Apfel A, Ye Y, Honma Y. First-In-Human Study: Dose Expansion of E7130 in Urothelial Carcinoma and Squamous Cell Carcinoma of the Head and Neck. Cancer Sci. 2026 Aug;117(8):2247-2258. doi: 10.1111/cas.70420. Epub 2026 May 27.

    PubMed 42203677

  • Doi T, Matsubara N, Naito Y, Kuboki Y, Harano K, Ono M, Urasaki T, Ohmoto A, Kawanai T, Hisai T, Ikezawa H, Shiba S, Ito K, Semba T, Asano O, Takahashi S. First-in-human study of E7130 (a tumor microenvironment-ameliorating microtubule inhibitor) in patients with advanced solid tumors: Primary results of the dose-escalation part. Cancer. 2023 Aug 1;129(15):2348-2359. doi: 10.1002/cncr.34788. Epub 2023 Apr 20.

    PubMed 37080942

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E7130 in people with Solid Tumors, run by Eisai Co., Ltd. at 9 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 11 inclusion and 14 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: stopped early, as of the sponsor's last update on 23 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 9 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 23 Oct 2026). 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 Assigned to Every 2 Weeks Regimen With Dose-limiting Toxicities (DLTs) (time frame: Cycle 1 (Cycle length=28 days)). The study lists 7 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 NCT03444701, which also lists 2 linked publications.

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 23 Oct 2026.

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