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New drug cocktail shows promise for rare sarcomas

NCT ID NCT03526679

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Taipei Veterans General Hospital

    Taipei, Taiwan, Taiwan

More trials for these conditions

Other studies related to the condition(s) this trial covers.