Clinical trial · Interventional
Eribulin and Lenvatinib in Advanced Solid Tumors
Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)
NCT02640508CI-TRIAL-00076991completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eribulin | Drug | Eribulin | ALIAS |
| Lenvatinib | Drug | Lenvatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination Eribulin and lenvatinib
- description
- Eribulin will be given on days 1 and 8. Lenvatinib will be given daily in each 28 day cycle.
- interventionNames
- Drug: Eribulin
- Drug: Lenvatinib
Primary outcomes (2)
- measure
- Overall Response Rate of Lenvatinib and Eribulin (Phase II)
- timeFrame
- The overall response rate will be assessed after two cycles of therapy (1 cycle = 3 weeks) until the date of first documentation of disease progression or death (whichever occurs first) over an average of 18 months.
- description
- Defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) as assessed by independent imaging review.
- measure
- Progression Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage IV breast cancer, stage IV NSCLC (Non-Small Cell Lung Cancer) (, stage IV sarcoma * ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) 0-2 * Measurable disease * No more than 4 prior chemotherapeutic regimens for metastatic disease * Patients must be \>/= 18 years. * Patients may not have received eribulin or lenvatinib previously * Patients must have a life expectancy of greater than 12 weeks. * Patients may have had a prior diagnosis of cancer if it has been \> 5 years since their last treatment and are considered free of disease. * Patients must have normal organ and marrow function as defined below: Leukocytes ≥ 3,000/uL Absolute neutrophil count ≥ 1,500/uL Platelets ≥ 100,000/uL Child Pugh score ≤ 10 Patients must be able to swallow and retain oral medication. All patients must have given signed, informed consent prior to registration on study. Exclusion Criteria: * Women who are pregnant or lactating are not eligible for study treatment. * Patients who are undergoing concomitant radiotherapy are NOT eligible for participation. * Patients who are receiving any other investigational agents or concurrent anticancer therapy are NOT eligible for participation. Previous systemic treatment and/or radiation therapy is allowed with a 14 day washout period prior to registration. * Lesions that have been radiated previously cannot be considered target lesions * Prior treatment related side effects must have resolved to \< Grade 2 severity per Common Terminology Criteria for Adverse Events (CTCAE version 4.03), except alopecia and infertility. * Patients who are taking any herbal (alternative) medicines are NOT eligible for participation. Patients must be off any such medications by the time of registration. * Patients with known brain metastases are NOT eligible for participation unless the brain metastases are treated (either with surgical excision, stereotactic radiosurgery or radiotherapy) and have been stable for at least 4 wks per MR performed, the patient is asymptomatic and has discontinued corticosteroids if taken for that purpose. * Patients with any of the following conditions or complications are NOT eligible for participation: 1. GI tract disease resulting in an inability to take oral medication 2. Malabsorption syndrome 3. Require IV alimentation 4. History of prior surgical procedures affecting absorption 5. Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis). 6. Hypersensitivity of any of the components of eribulin or lenvatinib 7. History of significant neurological ( no neuropathy more than grade 2) or psychiatric disorders 8. Significant non neoplastic liver disease (Cirrhosis, active chronic hepatitis) 9. Immunocompromised subjects, including patients with human immunodeficiency virus 10. Significant non neoplastic renal disease 11. Active infection requiring systemic therapy. 12. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment 13. Prolongation of QTc interval to more than 480 milliseconds when electrolyte balance is normal 14. Major surgery within 4 weeks prior to first dose of the study drug.
References
Publications (1)
- DERIVEDBanwait R, Ko H, Michalek J, Liu Q, Lathrop K, Bowhay-Carnes E, Fotopoulos G, Sarantopoulos J, Elledge R, Taverna J, Karnad A, Siziopikou KP, Kaklamani V. Pilot phase II study of the combination of lenvatinib (L) and eribulin (E) in advanced solid tumors. Int J Cancer. 2025 Aug 15;157(4):752-759. doi: 10.1002/ijc.35446. Epub 2025 Apr 15. PMID 40232157