Eribulin and Lenvatinib in Advanced Solid Tumors

NCT ID: NCT02640508

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2023-01-12

Brief Summary

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

Conditions

Cancer; Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination Eribulin and lenvatinib

Eribulin will be given on days 1 and 8. Lenvatinib will be given daily in each 28 day cycle.

Group Type: EXPERIMENTAL

Eribulin

Intervention Type: DRUG

Will be given by I.V. at 1.4 mg/m2 on day 1 and day 8.

Lenvatinib

Intervention Type: DRUG

Will be taken orally at 20-24 mg daily in each 21 day cycle.

Interventions

Eribulin

Will be given by I.V. at 1.4 mg/m2 on day 1 and day 8.

Intervention Type: DRUG

Lenvatinib

Will be taken orally at 20-24 mg daily in each 21 day cycle.

Intervention Type: DRUG

Other Intervention Names

Halaven; Lenvima

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: collaborator

Virginia G. Kaklamani

OTHER

Sponsor Role: lead

Responsible Party

Virginia G. Kaklamani

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Virginia Kaklamani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

Cancer Therapy and Research Center University of Texas Health Science Center San Antonio

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC20150891H

Identifier Type: OTHER

Identifier Source: secondary_id

CTMS 15-2139

Identifier Type: -

Identifier Source: org_study_id