Lenvatinib and Eribulin in Advanced Soft Tissue Sarcoma

NCT03526679 | Completed Phase 1 Results DMC

• 1 other identifier: 201801101MIPB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to test the safety and efficacy of the combination of lenvatinib, a drug that can inhibit the growth of supplying vessels around the tumors, and eribulin, a chemotherapy drug that targets the cancer cell during mitosis, in inoperable or metastatic adipocytic sarcoma and leiomyosarcoma.

Conditions

Leiomyosarcoma; Liposarcoma; Soft Tissue Sarcoma Adult; Advanced Cancer

Keywords

soft tissue sarcoma; phase Ib/II; advanced cancer

Outcome Measures

Primary Outcomes (1)

• The Objective Response Rate (ORR) Based on RECIST 1.1

  We will measure the radiographic changes of the tumor based on a prespecified criteria called RECIST (Response evaluation criteria in solid tumors). A tumor decreased in the sum of longest diameters of measurable tumors of more than 30% is considered responsive; a growth of tumor more than 20% in the sum of the longest diameter is considered disease progression; and shrinkage or growth between these intervals is considered stable disease (SD).

  24 weeks

Secondary Outcomes (4)

• The Proportion of Patients Who Are Progression-free and Alive at 24 Weeks

  24 weeks

• Overall Survival (OS) Rate at 12-months

  12 months

• Overall Survival (OS) Rate at 6 Months

  6 months

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  6 months

Study Arms (1)

Experimental arm

EXPERIMENTAL

The combination of lenvatinib and eribulin

Drug: Eribulin; Drug: Lenvatinib

Interventions

Eribulin DRUG

lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days

Also known as: Halaven

Experimental arm

Lenvatinib DRUG

lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days

Also known as: Lenvima

Experimental arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A histological confirmed adipocytic sarcoma (dedifferentiated, myxoid, or pleomorphic) or leiomyosarcoma that is either inoperable locally advanced or metastatic
• Advanced adipocytic sarcoma and leiomyosarcoma who have received no more than 2 lines of systemic chemotherapy in the advanced setting (not including adjuvant chemotherapy).
• 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.
• ECOG PS 0 or 1 or Karnofsky performance status (KPS) ≥ 70
• 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
• Age 20 or older.
• Patient's life expectancy is more than 3 months

You may not qualify if:

• Patients who had received lenvatinib or eribulin treatment
• 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).
• Patients with clinical signs or symptoms of gastrointestinal obstruction and who require parenteral hydration and/or nutrition because of obstruction.
• Patients with uncontrollable hypertension (defined as systolic blood pressure over 140mmHg and/or diastolic pressure over 90mmHg despite anti-hypertensive medications)
• 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.
• Bleeding subjects at risk for severe hemorrhage.
• Arterial thromboembolic event within the past 6 months, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.
• History of allergic reaction to compounds of similar chemical composition to the study drugs
• Pregnancy or lactation.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Sites (2)

Taipei Veterans General Hospital

Taipei, Taiwan, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• Chen TW, Hsu CL, Hong RL, Lee JC, Chang K, Yu CW, Chen SC, Guo JC, Chen ML, Hsu MC, Kung TF, Cheng AL, Yen CC. A Single-Arm Phase Ib/II Study of Lenvatinib plus Eribulin in Advanced Liposarcoma and Leiomyosarcoma. Clin Cancer Res. 2022 Dec 1;28(23):5058-5065. doi: 10.1158/1078-0432.CCR-22-2092.

  PMID: 36129471 DERIVED

MeSH Terms

Conditions

Leiomyosarcoma; Liposarcoma; Sarcoma

Interventions

eribulin; lenvatinib

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Adipose Tissue

Results Point of Contact

• Title: Dr. Tom Wei-Wu Chen
• Organization: National Taiwan University Hospital

tomwchen@ntuh.gov.tw

+886-2-23123456

Study Officials

• Wei-Wu Chen, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 16, 2018
• Study Start: July 12, 2018
• Primary Completion: June 30, 2021
• Study Completion: October 30, 2025
• Last Updated: December 5, 2025
• Results First Posted: November 25, 2024

Record last verified: 2025-10

Locations

TW (2)