Eribulin and Lenvatinib in Advanced Solid Tumors

NCT02640508 | Completed Phase 2 Results DMC

• 2 other identifiers: CTMS 15-2139HSC20150891H
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Solid Tumor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Overall Survival Rate

  Baseline to 50 months

• Lenvatinib and Eribulin Toxicities Will be Graded Using NCI CTCAE Version 4.03

  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.

Study Arms (1)

Combination Eribulin and lenvatinib

EXPERIMENTAL

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

Drug: Eribulin; Drug: Lenvatinib

Interventions

Eribulin DRUG

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

Also known as: Halaven

Combination Eribulin and lenvatinib

Lenvatinib DRUG

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

Also known as: Lenvima

Combination Eribulin and lenvatinib

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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:
• GI tract disease resulting in an inability to take oral medication
• Malabsorption syndrome
• Require IV alimentation
• History of prior surgical procedures affecting absorption
• Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
• Hypersensitivity of any of the components of eribulin or lenvatinib
• History of significant neurological ( no neuropathy more than grade 2) or psychiatric disorders

Sponsors & Collaborators

• Virginia G. Kaklamani: lead
• Eisai Inc.: collaborator

Study Sites (1)

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

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

eribulin; lenvatinib

Results Point of Contact

• Title: Virginia Kaklamani, MD
• Organization: UT Health San Antonio

kaklamani@uthscsa.edu

210-450-3838

Study Officials

• Virginia Kaklamani, MD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2015
• First Posted: December 29, 2015
• Study Start: May 1, 2016
• Primary Completion: November 24, 2020
• Study Completion: January 12, 2023
• Last Updated: May 9, 2024
• Results First Posted: May 9, 2024

Record last verified: 2024-04

Locations

US (1)