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.
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
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
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- 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)
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- 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
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 group | Role | What they receive |
|---|---|---|
| E7130 (2-Week Regimen) | Experimental | Part 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) | Experimental | Part 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.
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)
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)
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
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
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
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
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)
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])
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)
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)
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)
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)
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)
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)
Part 1 and Part 2: Recommended Dose for Future Studies
Measured: From start of the study up to 82.5 months
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)
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)
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)
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)
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)
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)
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)
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.
- First posted23 Feb 2018
- Study start5 Feb 2018
- Primary completion27 Dec 2024
- Study completion27 Dec 2024
Why it stopped: The trial was prematurely terminated due to the sponsor's decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 42203677Doi 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