New drug cocktail shows promise for rare sarcomas
NCT ID NCT03526679
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a combination of two drugs, lenvatinib and eribulin, in 30 people with advanced soft tissue sarcomas (liposarcoma or leiomyosarcoma) that could not be removed by surgery or had spread. The goal was to see if the combo could shrink tumors or slow their growth. The trial is now complete, and results will help decide if this approach deserves further study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lenvatinib and eribulin
- What this could lead to
- If it works, this combination could offer a new treatment option for people with advanced soft tissue sarcomas that are hard to treat.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. The drugs can cause side effects like fatigue, nausea, and high blood pressure.
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
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
30 people
The number who actually took part.
- Started
-
Jul 2018
- Finished
-
Oct 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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 1. A histological confirmed adipocytic sarcoma (dedifferentiated, myxoid, or pleomorphic) or leiomyosarcoma that is either inoperable locally advanced or metastatic 2. Advanced adipocytic sarcoma and leiomyosarcoma who have received no more than 2 lines of systemic chemotherapy in the advanced setting (not including adjuvant chemotherapy). 3. At least one measurable tumor according to RECIST 1.1. If the measurable lesion has previously received radiotherapy, the tumor must be a progressive lesion after radiotherapy. 4. ECOG PS 0 or 1 or Karnofsky performance status (KPS) ≥ 70 5. Patients must have adequate organ function and marrow reserve measured within 14 days prior to randomization as defined below: * Hemoglobin ≥ 9.0 g/dL; * Absolute neutrophil count ≥ 1,500 /µL; * Platelets ≥ 75,000/µL; * Total bilirubin ≤ 1.5 x upper normal limit; * aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) ≤ 2.5 x upper normal limit; for patients with liver metastases AST(SGOT)/ALT(SGPT) ≤ 5 x upper normal limit is allowed; * Serum creatinine ≤ 1.5mg/dL or creatinine clearance ≥ 50ml/min; * activated partial thromboplastin time (aPTT) \< 1.5 x upper normal limit (unless on therapeutic anti-coagulation); * Proteinuria ≤ 1+ with urine dipstick, if \> 1+, 24-hour urine protein must be ≤ 1 g 6. Age 20 or older. 7. Patient's life expectancy is more than 3 months 8. All women of childbearing potential must have a negative pregnancy test obtained within 72 hours before starting therapy. 9. Patients with reproductive potential must use effective contraception (hormone or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after the completion of therapy. 10. Patient needs to have adequate wash-out period from previous systemic treatment(s): (1) 2 weeks for any other oral anti-cancer targeted agents (2) 3 weeks for any other cytotoxic chemotherapy (except for mitomycin-C, which will require 6 weeks) (3) 3 weeks for monoclonal antibodies, including immune checkpoint inhibitors Exclusion criteria 1. Patients who had received lenvatinib or eribulin treatment 2. Patients who had leptomeningeal metastasis, either diagnosed by brain imaging study or confirmed by cerebrospinal fluid cytology examination (patients with brain metastasis that are under control is eligible). 3. Patients with clinical signs or symptoms of gastrointestinal obstruction and who require parenteral hydration and/or nutrition because of obstruction. 4. Patients with uncontrollable hypertension (defined as systolic blood pressure over 140mmHg and/or diastolic pressure over 90mmHg despite anti-hypertensive medications) 5. Patients with the following cardiac disease * Prolongation of corrected QT (QTc) interval to \>480 milliseconds (ms). * Significant cardiovascular impairment: history of (a) congestive heart failure greater than New York Heart Association (NYHA) Class II; (b) unstable angina; (c) myocardial infarction; (d) stroke; or (e) cardiac arrhythmia associated with hemodynamic instability within 6 months of the first dose of study drugs. 6. Bleeding subjects at risk for severe hemorrhage. 7. Arterial thromboembolic event within the past 6 months, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction. 8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment. 9. History of allergic reaction to compounds of similar chemical composition to the study drugs 10. Pregnancy or lactation.
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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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National Taiwan University Hospital
Taipei, 100, Taiwan
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Taipei Veterans General Hospital
Taipei, Taiwan, Taiwan
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