Compassionate Use of Eribulin for the Treatment of Advanced Breast Cancer Refractory to All Other Marketed Therapies

NCT01142661 | Completed Results

• 1 other identifier: E7389-G000-399
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to provide eribulin to patients with advanced breast cancer who have no other treatment options and therapy is requested by an Investigator.

Conditions

Breast Cancer

Keywords

Advanced breast cancer refractory to all commercially available therapies

Outcome Measures

Primary Outcomes (2)

• Safety

  General safety will be assessed by monitoring and recording the number of patients with adverse events (serious and nonserious) for duration of treatment which continued until disease progression, unacceptable toxicity or death.

  For duration of treatment, an average of 5 months

• Safety

  General safety will be assessed by monitoring and recording the number of patients with serious adverse events for duration of treatment which continued until disease progression, unacceptable toxicity or death.

  For duration of treatment, an average of 5 months

Study Arms (1)

Eribulin mesylate

EXPERIMENTAL

Drug: Eribulin Mesylate

Interventions

Eribulin Mesylate DRUG

Eribulin Mesylate: A dose of 1.4 mg/m\^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.

Eribulin mesylate

Eligibility Criteria

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

You may qualify if:

• In order to receive eribulin under this protocol, the subjects oncologist must have documented experience treating subjects with eribulin in a prior clinical study. Subjects who meet all of the following criteria will be included in the treatment protocol:
• Recurrent, locally advanced or metastatic breast cancer that has progressed on or after the last anti-cancer therapy.
• Prior treatment with, ineligibility for, or commercial unavailability of each of the following therapies:
• Anthracyclines, taxanes, and capecitabine.
• Ixabepilone in countries where this agent is marketed.
• Trastuzumab for Her-2 positive disease.
• Hormonal therapy in hormone receptor-positive disease.
• All other marketed therapies, eg, gemcitabine or vinorelbine, used for the treatment of advanced breast cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
• Serum creatinine \</= 2.0 mg/dL or creatinine clearance \>/= 40 mL/min according to Cockcroft and Gault formula.
• Absolute neutrophil count \>/= 1.5 x 10\^9/L, hemoglobin \>/= 10 g/dL (can be corrected by growth factor or transfusion), and platelet count \>/= 100 x 10\^9/L.
• Total bilirubin \</= 1.5 x upper limit of normal (ULN). Alkaline phosphatase (AP), alanine aminotransferase, and aspartate aminotransferase \</= 3 x ULN (\</= 5 x ULN in case of liver metastases). In case AP is \>3 x ULN (in absence of liver metastases) or \>5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.
• Are willing and able to comply with all aspects of the treatment protocol.
• Provide written informed consent.
• Females, age \>/= 18 years.

You may not qualify if:

• Eligible for any other eribulin study that is open in the same region.
• Existing anti-cancer therapy-related toxicities of Grade \>/= 2, except that alopecia and Grade 2 neuropathy are acceptable.
• History of congestive heart failure with New York Heart Association Classification \>II, unstable angina, myocardial infarction within the past 6 months, serious cardiac arrhythmia.
• Electrocardiogram with QTc interval \>/= 500 msec based upon Bazett's formula (QTcB).
• The Investigator believes the subject to be medically unfit to receive eribulin or unsuitable for any other reason.
• Females who are pregnant (positive B-hCG test) or breastfeeding.
• Subject with hypersensitivity to eribulin or any of the excipients.
• Subjects 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 treatment in this treatment protocol. Any signs (eg, radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting the treatment protocol.
• Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the treatment protocol.
• Subjects who are known to be human immunodeficiency virus positive because the neutropenia caused by the eribulin treatment may make such subjects particularly susceptible to infection.
• Subjects with meningeal carcinomatosis.
• Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
• Subjects who have received any of the following treatments within the specified period before the start of treatment:
• Any investigational drug, chemotherapy, radiation, or biological or targeted therapy within 2 weeks.
• Hormonal therapy within 1 week.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (5)

Unknown Facility

La Verne, California, United States

Location

Unknown Facility

Nyack, New York, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Bismarck, North Dakota, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Prash Gopalakrishna
• Organization: Eisai Inc.

888-422-4743

Study Officials

• Eisai Medical Services

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 11, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2011
• Last Updated: September 20, 2013
• Results First Posted: September 20, 2013

Record last verified: 2013-09

Locations

US (5)