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Solid TumorPhase 1NCT03207672

Study of E7389 Liposomal Formulation in Participants With Solid Tumor

A Phase 1 study testing E7389-LF in people with Solid Tumor, run by Eisai Co., Ltd. at 12 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The maximum tolerated dose (MTD) of E7389 liposomal formulation (E7389-LF) will be determined in the dose escalation part. Safety, pharmacokinetics (PK) and efficacy will be assessed using treatment regimen evaluated in dose escalation part in participants with breast cancer (up to 3 prior regimens of chemotherapy) in… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Solid Tumor
What is being tested?
E7389-LF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
12 sitesJapan
Study dates
18 Aug 2017to 31 Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 with advanced, nonresectable, or recurrent solid tumor for which no alternative standard therapy or no effective therapy exists
  • Expansion-part 1 only: breast cancer with confirmed diagnosis, human epidermal growth factor (HER2) negative (immunohistochemistry [IHC] 0/1+, or fluorescence in situ hybridization [FISH] negative), prior chemotherapy of anthracycline and taxane (unless contraindicated), and up to 3 prior chemotherapy regimens to advanced or metastatic disease Expansion-part 2 only: nonresectable ACC with confirmed diagnosis and one or more prior chemotherapy regimens (unless contraindicated) Expansion-part 3, 4 and 5 only: nonresectable GC, EGC and SCLC with confirmed diagnosis and 2 or more prior chemotherapy regimens (unless contraindicated) (1 or more prior chemotherapy regimens for EGC participant who received combination therapy of platinum and taxane).
  • Ex-part 6 only: breast cancer with confirmed diagnosis, HER2 negative (IHC 0/1+, or FISH negative) and without prior chemotherapy regimens to advanced or metastatic disease. Participants with triple-negative breast cancer (TNBC) who are PD-L1 negative as assessed by the site or who are medically determined by the investigator(s) to be ineligible for treatment with atezolizumab and other immune-checkpoint inhibitors will be included.
  • Life expectancy of greater than or equal to (>=) 12 weeks
  • Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) of 0 to 1
  • Japanese participants aged >=20 years at the time of informed consent
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  • All adverse events (AEs) due to previous anti-cancer therapy have either returned to Grade 0 or 1 except for alopecia and Grade 2 peripheral neuropathy
  • Adequate washout period before study drug administration:
  • Chemotherapy, hormonal therapy and radiotherapy: 3 weeks or more
  • Any therapy with antibody: 4 weeks or more
  • Any investigational drug or device: 4 weeks or more
  • Blood/platelet transfusion or granulocyte-colony stimulating factor (G-CSF): 2 weeks or more
  • Adequate renal function defined as serum creatinine less than (<) 2.0 milligrams per deciliter (mg/dL) or creatinine clearance >=40 milliliters per minute (mL/min) per the Cockcroft and Gault formula
  • Adequate bone marrow function:
  • Absolute neutrophil count (ANC) >=2,000/millimeters cubed (mm^3) (>=2.0 × 10^3/microliter [µl])
  • Platelets >=100,000/mm^3 (>=100 × 10^9/Liter [L])
  • Hemoglobin >=9.0 grams (g)/dL (Expansion-part only: >=8.5 g/dL)
  • Adequate liver function:
  • Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) less than or equal to (<=) 1.5
  • Total bilirubin <=1.5 × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's syndrome
  • Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=3 × ULN (<=5.0 times ULN in the participants with liver metastases)
  • Expansion-part only: At least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Willing and able to give informed consent and comply with all aspects of the protocol

Who cannot join

  • Any of cardiac conditions as follows:
  • Heart failure New York Heart Association (NYHA) Class II or above
  • Unstable ischaemic heart disease (myocardial infarction within 6 months prior to starting study drug, or angina requiring use of nitrates more than once weekly)
  • Prolongation of Fridericia's corrected QT (QTcF) interval to greater than (>) 480 milliseconds (msec)
  • History of hypersensitivity reaction by liposomal formulation agent
  • Major surgery within 21 days prior to starting study drug
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  • Previous treatment with eribulin
  • Previous radiation therapy encompassing an extensive region including the bone marrow (example, >30% of bone marrow)
  • Known intolerance to the study drug or any of the excipients
  • Known to be human immunodeficiency virus (HIV) positive
  • Active viral hepatitis (B or C) as demonstrated by positive serology or requiring treatment
  • Diagnosed with meningeal carcinomatosis
  • Participants with brain or subdural metastases or invasion 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.
  • Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
  • Expansion-part only: history of active malignancy (except for primary tumor, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, carcinoma in-situ of the bladder or cervix, or early stage gastric/colorectal cancer) within the past 24 months prior to the first dose of study drug
  • Evidence of clinically significant disease/status (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
  • Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [β-hCG] or hCG test). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
  • Males with impregnate potential or females of childbearing potential who or whose partner do not agree with medically effective method of contraception throughout the entire study period and for 28 days (90 days for male) after study drug discontinuation
  • Ex-part 6 only: Active or acute oral infection requiring dental treatment
  • Ex-part 6 only: Participants who received taxanes as neoadjuvant or adjuvant chemotherapy and have radiographically progressive disease by investigator(s) decision within 12 months after the last dose of taxane
  • Ex-part 6 only: Child-Pugh score B or C

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Japan12 sites

  • Eisai Trial Site 9

    Bunkyo-ku, Tokyo

  • Eisai Trial Site 1

    Chuo-ku, Tokyo

  • Eisai Trial Site 12

    Fukuoka

  • Eisai Trial Site 10

    Hidaka, Saitama

  • Eisai Trial Site 3

    Kashiwa, Chiba

  • Eisai Trial Site 4

    Koto-ku, Tokyo

  • Eisai Trial Site 11

    Kyoto

  • Eisai Trial Site 8

    Nishinomiya, Hyōgo

  • Eisai Trial Site 2

    Osaka

  • Eisai Trial Site 5

    Sapporo, Hokkaido

  • Eisai Trial Site 7

    Shinjuku-ku, Tokyo

  • Eisai Trial Site 6

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: An Open-label Phase 1 Study of E7389 Liposomal Formulation in Subjects With Solid Tumor

The maximum tolerated dose (MTD) of E7389 liposomal formulation (E7389-LF) will be determined in the dose escalation part. Safety, pharmacokinetics (PK) and efficacy will be assessed using treatment regimen evaluated in dose escalation part in participants with breast cancer (up to 3 prior regimens of chemotherapy) in the expansion part 1 and in participants with adenoid cystic carcinoma (ACC), gastric cancer (GC), esophageal cancer (EGC), small cell lung cancer (SCLC) and breast cancer (with no prior regimens of chemotherapy) in the expansion part 2, 3, 4, 5 and 6 respectively.

Conditions
Solid Tumor
Being tested
E7389-LF
Keywords
E7389 liposomal formulation, dose escalation, maximum tolerated dose, pharmacokinetics

What participants receive

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

  • E7389-LFDrug

    intravenous infusion

Study groups in NCT03207672
Study groupRoleWhat they receive
Schedule 1: E7389-LFExperimentalParticipants will receive E7389-liposomal formulation (LF) at a starting dose of 1.0 to 2.5 milligrams per meters squared (mg/m^2), administered as an intravenous (IV) infusion on Day 1 of a 21-day cycle (tri-weekly).
Receives: Drug: E7389-LF
Schedule 2: E7389-LFExperimentalParticipants will receive E7389-LF at a starting dose of 1.0 to 1.5 mg/m^2, administered as an IV infusion on Day 1 and Day 15 of a 28-day cycle (bi-weekly).
Receives: Drug: E7389-LF

What is being measured

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

  1. Maximum tolerated dose (MTD) of E7389 liposomal formulation (E7389-LF)

    The MTD is defined as the maximum dose with 0 or 1 dose-limiting toxicity (DLT) in 6 participants. DLTs are defined as study drug-related adverse events (AEs) and graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) 4.03 occurring during Cycle 1 (Schedule 1: 3 weeks; Schedule 2: 4 weeks) of the Dose Escalation part of the study (DE-part).

    Measured: Cycle 1 (21 days): Schedule 1; Cycle 1 (28 days): Schedule 2

Secondary outcomes (10)

  1. Number of participants with any serious adverse event (SAE)

    The number of participants with any SAE will be assessed as a measure of the safety and tolerability of E7389- liposomal formulation (LF).

    Measured: From date of first dose of study drug up to 30 days after last administration of study drug (approximately up to 8 years)

  2. Number of participants with any adverse event (AE)

    The number of participants with any AE will be assessed as a measure of the safety and tolerability of E7389-LF.

    Measured: From date of first dose of study drug up to 30 days after last administration of study drug (approximately up to 8 years)

  3. Maximum observed concentration (Cmax) of E7389-LF

    Blood samples will be collected for pharmacokinetic (PK) analyses. Cmax is the highest concentration of drug in the blood that is measured after a dose. DE = Dose Escalation. Exp = Expansion.

    Measured: DE part: predose; 15 minutes (min) after start of infusion (inf); 5 min after end of inf on Cycle 1 Day 1 (C1D1); 0.5, 1, 2, 4, 6, 8, and 24 hours (hr) postdose (from end of inf on C1D1); C1D4; C1D8; C1D10. Exp part: predose and end of inf on C1D1; C1D8

  4. Time from dosing to the maximum observed concentration (Tmax) of E7389-LF

    Blood samples will be collected for PK analyses. Tmax is the time to the highest concentration of drug in the blood that is measured after a dose. DE = Dose Escalation. Exp = Expansion.

    Measured: DE part: predose; 15 minutes (min) after start of infusion (inf); 5 min after end of inf on Cycle 1 Day 1 (C1D1); 0.5, 1, 2, 4, 6, 8, and 24 hours (hr) postdose (from end of inf on C1D1); C1D4; C1D8; C1D10. Exp part: predose and end of inf on C1D1; C1D8

  5. Area under the plasma concentration time course profile (AUC)

    Blood samples will be collected for PK analyses. AUC represents the overall amount of drug in the bloodstream after dosing. DE = Dose Escalation. Exp = Expansion.

    Measured: DE part: predose; 15 minutes (min) after infusion (inf) start; 5 min after end of inf on Cycle 1 Day 1 (C1D1); 0.5, 1, 2, 4, 6, 8, and 24 hours (hr) postdose (from end of inf on C1D1); C1D4; C1D8; and C1D10. Exp part: predose and end of inf on C1D1; C1D8

  6. Half-life (t1/2) of E7389-LF

    Blood samples will be collected for PK analyses. t1/2 is the time required for the concentration of the drug to reach half of its original value. DE = Dose Escalation. Exp = Expansion.

    Measured: DE part: predose; 15 minutes (min) after start of infusion (inf); 5 min after end of inf on Cycle 1 Day 1 (C1D1); 0.5, 1, 2, 4, 6, 8, and 24 hours (hr) postdose (from end of inf on C1D1); C1D4; C1D8; C1D10. Exp part: predose and end of inf on C1D1; C1D8

  7. Clearance (CL) of E7389-LF

    Blood samples will be collected for PK analyses. Clearance is the volume of plasma cleared of the drug per unit time. DE = Dose Escalation. Exp = Expansion.

    Measured: DE part: predose; 15 minutes (min) after infusion (inf) start; 5 min after end of inf on Cycle 1 Day 1 (C1D1); 0.5, 1, 2, 4, 6, 8, and 24 hours (hr) postdose (from end of inf on C1D1); C1D4; C1D8; and C1D10. Exp part: predose and end of inf on C1D1; C1D8

  8. Volume of distribution (Vd) of E7389-LF

    Blood samples will be collected for PK analyses. Vd is the volume in which a drug is distributed. DE = Dose Escalation. Exp = Expansion.

    Measured: DE part: predose; 15 minutes (min) after infusion (inf) start; 5 min after end of inf on Cycle 1 Day 1 (C1D1); 0.5, 1, 2, 4, 6, 8, and 24 hours (hr) postdose (from end of inf on C1D1); C1D4; C1D8; and C1D10. Exp part: predose and end of inf on C1D1; C1D8

  9. Objective response rate (ORR)

    ORR is defined as the percentage of participants who have a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. For target lesions, CR is defined as the disappearance of all target lesions. For non-target lesions, CR is defined as the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than [<] 10 millimeter [mm] short axis). Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. For target lesions, PR is defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From date of first dose of study drug until first documentation of CR or PR (up to approximately 8 years)

  10. Progression free survival (PFS)

    PFS is defined as the time from the date of first dose of study drug to the date of the first documentation of disease progression or date of death, whichever occurs first. For target lesions PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, progressive disease is defined as the unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.

    Measured: From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first (up to approximately 8 years)

Timeline

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

  1. First posted5 Jul 2017
  2. Study start18 Aug 2017
  3. Primary completion19 Jul 2018
  4. Study completion31 Mar 2027 (estimated)

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
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03207672
Sponsor's protocol ID
E7389-J081-114
Status last verified
Aug 2026
First submitted
19 Jun 2017
Last updated
27 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ishiguro H, Miyoshi Y, Yasojima H, Watanabe J, Takano T, Shimomura A, Tokunaga E, Mukohara T, Naoi Y, Matsuoka D, Okumura S, Otake Y, Suzuki T, Takase T, Semba T, Zhao Z, Yonemori K. E7389-LF as a first-line chemotherapy for patients with metastatic/advanced HER2-negative breast cancer: results from the phase 1 dose-expansion part of study 114. Breast Cancer Res. 2026 Sep 17;28(1):158. doi: 10.1186/s13058-026-02295-8.

    PubMed 42754887

  • Masuda N, Ono M, Mukohara T, Yasojima H, Shimoi T, Kobayashi K, Harano K, Mizutani M, Tanioka M, Takahashi S, Kogawa T, Suzuki T, Okumura S, Takase T, Nagai R, Semba T, Zhao ZM, Ren M, Yonemori K. Phase 1 study of the liposomal formulation of eribulin (E7389-LF): Results from the breast cancer expansion cohort. Eur J Cancer. 2022 Jun;168:108-118. doi: 10.1016/j.ejca.2022.03.004. Epub 2022 Apr 29.

    PubMed 35500404

  • Sato J, Shimizu T, Koyama T, Iwasa S, Shimomura A, Kondo S, Kitano S, Yonemori K, Fujiwara Y, Tamura K, Suzuki T, Takase T, Nagai R, Yamaguchi K, Semba T, Zhao ZM, Ren M, Yamamoto N. Dose Escalation Data from the Phase 1 Study of the Liposomal Formulation of Eribulin (E7389-LF) in Japanese Patients with Advanced Solid Tumors. Clin Cancer Res. 2022 May 2;28(9):1783-1791. doi: 10.1158/1078-0432.CCR-21-3518.

    PubMed 35180771

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E7389-LF in people with Solid Tumor, run by Eisai Co., Ltd. at 12 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 23 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

This study is still under way. Results are not available in the source record yet.

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?

Maximum tolerated dose (MTD) of E7389 liposomal formulation (E7389-LF) (time frame: Cycle 1 (21 days): Schedule 1; Cycle 1 (28 days): Schedule 2). 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 NCT03207672, which also lists 3 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 27 Aug 2026.

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