Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

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

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

Eribulin

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

Virginia Kaklamani, MD

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

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.

Eribulin and Lenvatinib in Advanced Solid Tumors

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

Defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) as assessed by independent imaging review.

Progression-free survival (PFS) will be defined as the time from the first study treatment to the first occurrence of progression or death.

Adverse events are graded in the NCI CTCAE version 4.03 scale and reported by number of adverse events per grade

Eisai Inc.

Virginia G. Kaklamani

Principal Investigator

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

For each cycle: Eribulin: Will be given by I.V. at 1.4 mg/m2 on day 1 and day 8 and Lenvatinib: Will be taken orally at 20-24 mg daily days 1-21 of each 28 day cycle.

Combination Eribulin and Lenvatinib

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

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

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

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 life expectancy of greater than 12 weeks, and adequate hematologic, liver and renal function.

0 Fully active; no performance restrictions.

1. Strenuous physical activity restricted; fully ambulatory and able to carry out light work.
2. Capable of all self-care but unable to carry out any work activities. Up and about \>50% of waking hours.

ECOG performance status

Mammary carcinoma

Lung carcinoma

Sarcoma

Tumor history

Partial Response

Stable Disease

Progression of Disease

Only 23 patients had evaluable disease as 6 subjects came off study early prior to first assessment due to toxicities.

Overall Response Rate of Lenvatinib and Eribulin (Phase II)

Progression Free Survival

Overall Survival Rate

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

All subjects that received investigational product, including those from Phase 1 that were not included in the analysis of data

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

Eribulin will be administered on cycle days 1 and 8; Lenvatinib is an orally administered medication given daily throughout each cycle. On days when both drugs are administered, Eribulin will be administered immediately prior to Lenvatinib.

Spots Global Cancer Trial Database for Eribulin and Lenvatinib in Advanced Solid Tumors

Trial Identification

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Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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