A Study to Evaluate Safety, Tolerability and Efficacy of Eribulin Mesylate in Treating Adult Females With Locally Advanced or Metastatic Breast Cancer

NCT03583944 | Completed Phase 4

• 1 other identifier: E7389-M065-401
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 18

Brief Summary

The purpose of this study is to evaluate clinical and laboratory safety of eribulin mesylate in treating participants with locally advanced or metastatic breast cancer, who have progressed after at least one regimen of chemotherapy which has included anthracycline and taxane therapy.

Conditions

Breast Neoplasms

Keywords

E7389; Tumors, Breast; Breast Cancer; Breast Carcinoma; Neoplasms, Breast

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Clinical Safety will be assessed by recording the adverse events (AEs) and serious AEs (SAEs) observed during the study period and its relation to the study medication. AE is defined as any untoward medical occurrence in a participant administered a treatment of medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, results in life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or results in a congenital anomaly/birth defect.

  Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months)

• Number of Participants with TEAEs Related to Laboratory Parameters

  AE is defined as any untoward medical occurrence in a participant administered a treatment of medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, results in life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or results in a congenital anomaly/birth defect. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.

  Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months)

Secondary Outcomes (2)

• Objective Tumor Response

  Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months)

• Objective Response Rate (ORR)

  Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months)

Study Arms (1)

Eribulin Mesylate 1.23 mg

EXPERIMENTAL

Participants will receive eribulin mesylate 1.23 mg intravenous (IV) infusion, given over 2 - 5 minutes on Days 1 and 8 of 21 days cycle for a total of 6 cycles.

Drug: Eribulin Mesylate

Interventions

Eribulin Mesylate DRUG

Eribulin mesylate IV infusion.

Also known as: Halaven

Eribulin Mesylate 1.23 mg

Eligibility Criteria

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

You may qualify if:

• Participants with locally advanced or metastatic breast cancer.
• Participants must have progressed after at least after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an Anthracycline and a Taxane unless participants who are not suitable for these treatments.
• Participants must have documented disease progression within or on 6 months from their last anti-cancer therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2.
• Participants must have normal organ and marrow function as defined below:
• Absolute neutrophil count greater than (\>) 1,500 per microliter (/mcL)
• Hemoglobin \>10.0 gram per deciliter (g/dL)
• Platelets \>100,000/mcl
• Serum total bilirubin less than (\<) 1.5\*upper limit of normal (ULN)
• Serum aspartate aminotransferase (AST) (Serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (Serum glutamic pyruvic transaminase \[SGPT\]) \<3\*ULN or \<5\*ULN in the presence of liver metastases
• Serum creatinine \<1.5 mg/dL.
• Females in reproductive age willing to follow adequate barrier contraceptive measures during the conduct of study.

You may not qualify if:

• Hypersensitivity to the active substance or any of the excipients.
• Participants who have received chemotherapy, radiation, or biological therapy within two weeks, or hormonal therapy within one week before study treatment start, or any investigational drug within four weeks before study treatment start.
• Participants receiving any other investigational agents.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, or other comorbid condition that investigator believes may compromise participant's condition.
• Participants requiring concurrent anti-cancer therapy during the study period.
• Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting study treatment.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (18)

HEMATO-ONCOLOGY CLINIC Vedanta Institute of Medical Sciences

Ahmedabad, Gujarat, 380009, India

Location

HealthCare Global Enterprises Ltd

Bangalore, Karnataka, 560027, India

Location

Srinivasam Cancer Care Multispecialty Hospitals India Pvt Ltd

Bangalore, Karnataka, 560072, India

Location

KR Hospital Mysore Medical College

Mysore, Karnataka, 570001, India

Location

Tata Memorial Hospital Department of Oncology

Mumbai, Maharashtra, 400012, India

Location

HCG NCHRI Cancer Centre

Nagpur, Maharashtra, 440026, India

Location

Lokmanya Hospital

Pune, Maharashtra, 411033, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

All India Institute of Medical Sciences

Bhubaneswar, Odisha, 751019, India

Location

Deep Hospital

Ludhiana, Punjab, 141002, India

Location

Sawai Man Singh Hospital

Jaipur, Rajasthan, 302001, India

Location

MNJ Institute of Oncology and Regional Cancer Centre

Hyderabad, Telangana, 500004, India

Location

J.K.Cancer Institute

Kanpur, Uttar Pradesh, 208002, India

Location

King George's Medical University,(Erstwhile Chhatrapati Shahuji Maharaj Medical University)

Lucknow, Uttar Pradesh, 226003, India

Location

Ajanta Research Centre, Ajanta Hospital & IVF Centre

Lucknow, Uttar Pradesh, 226005, India

Location

Nilratan Sircar Medical College and Hospital

Kolkata, West Bengal, 700014, India

Location

Netaji Subhash Chandra Bose Cancer Institute

Kolkata, West Bengal, 700016, India

Location

IPGME&R S.S.K.M Hospital

Kolkata, West Bengal, 700020, India

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Medical Director

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 12, 2018
• Study Start: March 28, 2018
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: November 27, 2019

Record last verified: 2018-07

Locations

IN (18)