New liposomal drug shows promise for Hard-to-Treat cancers
NCT ID NCT03207672
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This early-stage study tests a new drug called E7389 liposomal formulation in people with advanced solid tumors that have not responded to standard treatments. The main goal is to find the safest dose and check for side effects. The study also looks at how the drug works in specific cancers like breast cancer, adenoid cystic carcinoma, and small cell lung cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2017
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Eisai Trial Site 1
Chuo-ku, Tokyo, Japan
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Eisai Trial Site 10
Hidaka, Saitama, Japan
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Eisai Trial Site 11
Kyoto, Japan
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Eisai Trial Site 12
Fukuoka, Japan
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Eisai Trial Site 2
Osaka, Japan
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Eisai Trial Site 3
Kashiwa, Chiba, Japan
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Eisai Trial Site 4
Koto-ku, Tokyo, Japan
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Eisai Trial Site 5
Sapporo, Hokkaido, Japan
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Eisai Trial Site 6
Yokohama, Kanagawa, Japan
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Eisai Trial Site 7
Shinjuku-ku, Tokyo, Japan
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Eisai Trial Site 8
Nishinomiya, Hyōgo, Japan
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Eisai Trial Site 9
Bunkyo-ku, Tokyo, Japan
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