Eribulin and Lenvatinib in Advanced Solid Tumors

Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)

The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.

Study Overview

• Status: Completed
• Conditions: Cancer; Solid Tumor
• Intervention / Treatment: Drug: Eribulin; Drug: Lenvatinib

Detailed Description

This is a phase II clinical trial of the combination of eribulin, and Lenvatinib. A cycle will be defined as 21 days. Eribulin will be given on days 1 and 8 of each cycle. Lenvatinib will be given daily during each cycle.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Cancer Therapy and Research Center University of Texas Health Science Center San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination Eribulin and lenvatinib; Eribulin will be given on days 1 and 8. Lenvatinib will be given daily in each 28 day cycle.	Drug: Eribulin; Will be given by I.V. at 1.4 mg/m2 on day 1 and day 8.; Other Names: Halaven; Drug: Lenvatinib; Will be taken orally at 20-24 mg daily in each 21 day cycle.; Other Names: Lenvima

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate of Lenvatinib and Eribulin (Phase II)	Defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) as assessed by independent imaging review.	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.
Progression Free Survival	Progression-free survival (PFS) will be defined as the time from the first study treatment to the first occurrence of progression or death.	Baseline to 50 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Rate		Baseline to 50 months
Lenvatinib and Eribulin Toxicities Will be Graded Using NCI CTCAE Version 4.03	Adverse events are graded in the NCI CTCAE version 4.03 scale and reported by number of adverse events per grade	Safety will be evaluated from the time of registration until 30 days after last dose of treatment, resolution of the related AE or death up to 40 months.

Collaborators and Investigators

• Sponsor: Virginia G. Kaklamani
• Collaborators: Eisai Inc.
• Investigators: Principal Investigator: Virginia Kaklamani, MD, University of Texas Health Science Center San Antonio

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): November 24, 2020
• Study Completion (Actual): January 12, 2023

Study Registration Dates

• First Submitted: November 26, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (Estimated): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Lenvatinib
• Other Study ID Numbers: CTMS 15-2139; HSC20150891H (Other Identifier: University of Texas Health Science Center- San Antonio)