Study of E7389 for Advanced or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00965523
First received: August 20, 2009
Last updated: July 14, 2013
Last verified: July 2013
  Purpose

The purpose of this study (E7389-J081-224; hereafter referred to as Study 224) is to evaluate the safety of patients who continue to receive E7389 after completing the Phase II clinical study (E7389-J081-221; hereafter referred to as Study 221) of E7389 for advanced or relapsed breast cancer by intravenously administering E7389.


Condition Intervention Phase
Breast Cancer
Drug: Eribulin Mesylate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Extension Study of E7389 for Locally Advanced or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Number of Subjects With Adverse Events. [ Time Frame: Every week during treatment and up to 30 days after last dose of study treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
    Objective response measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria and is Complete Response (disappearance of all target lesions) plus Partial Response (at least 30% decrease in sum of longest diameter [LD] of target lesions compared baseline sum of LD). Tumor assessments every 6 weeks.


Enrollment: 81
Study Start Date: January 2008
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eribulin Mesylate Drug: Eribulin Mesylate
Eribulin mesylate 1.4 mg/m^2 intravenous infusion (IV) given over 2 to 5 minutes on Day 1 and 8 every 21 days.

Detailed Description:

Study 224 (Extension Period) was designed to evaluate the safety and efficacy of E7389 by collecting data from subjects who continued receiving E7389 after being transferred from Study 221 (Core Period). Thus, efficacy analyses performed in Study 221 were updated and reported with the additional data collected in Study 224. Objective response rate (ORR) and the number of subjects with adverse events are reported as outcome measures because these were the outcome measures of Study 221 which is a main study in the combined data. Also, safety analyses performed in Study 221 were updated and reported with the additional data collected in Study 224.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Female patients with histologically or cytologically confirmed breast cancer.
  2. Patients who have received prior chemotherapy including anthracycline and taxane.
  3. Patients aged 20 - 74 years when giving informed consent and who have given written voluntary consent for participating in this study before the completion of Study 221.
  4. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
  5. Patients with a measurable lesion.
  6. Patients with an expected survival of ≥ 3 months from the start of study drug therapy.
  7. Female patients in whom continued administration of E7389 following Study 221 will be useful.
  8. Patients who have met the criteria for starting the next cycle in Study 221.

Namely, patients who meet all of the following criteria:

  1. Neutrophil count >= 1,500 /µL
  2. Platelet count >= 100,000 /µL
  3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 times the upper limit of normal (ULN) in the facility or <= 5 times ULN in patients with hepatic metastasis)
  4. Total bilirubin <= 1.5 times ULN
  5. Serum creatinine <= 1.5 times ULN
  6. Non-hematological toxicity <= Grade 2 (excluding disease-associated events and laboratory abnormalities without clinical symptoms)

Exclusion criteria:

  1. Patients with systemic infection with a fever (≥38.0°C).
  2. Patients with pleural effusion, ascites or pericardial fluid requiring drainage.
  3. Patients with brain metastasis presenting clinical symptoms.
  4. Pregnant women, nursing mothers, or premenopausal women of childbearing potential. Premenopausal women of childbearing potential are defined as women who are <12 months after the latest menstruation and are positive in pregnancy test performed for enrollment or who have not taken the test and do not consent to take an appropriate contraceptive measure. Post-menopausal women must be amenorrheic for at least 12 months to make sure that they have no potential for becoming pregnant.
  5. Patients with serious complications:

    1. Patients with uncontrollable cardiac disease such as ischemic heart disease and arrhythmia at a level of severity that needs to be treated (excluding left ventricular hypertrophy, mild left ventricular volume overload and mild right leg block that accompany hypertension)
    2. Patients with myocardial infarction within 6 months prior to study entry
    3. Patients with a complication of hepatic cirrhosis
    4. Patients with interstitial pneumonia and pulmonary fibrosis
    5. Patients with a bleeding tendency
  6. Patients with an active double cancer.
  7. Pregnant women or nursing mothers.
  8. Patients who have received extensive radiotherapy (≥30% of bone marrow).
  9. Patients who refuse to receive the supportive therapy of blood transfusion for myelosuppression.
  10. Patients who are participating in other clinical studies.
  11. Patients who are judged by the principal investigator or the other investigators to be inappropriate as patients in this clinical study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965523

Locations
Japan
Nagoya, Aichi, Japan
Kure, Hiroshima, Japan
Chuo, Tokyo, Japan
Fukuoka, Japan
Kagoshima, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Tatsuo Watanabe Oncology Clinical Development Section. JAC PCU., Eisai, Co., Ltd
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00965523     History of Changes
Obsolete Identifiers: NCT00633100
Other Study ID Numbers: E7389-J081-224, E7389-J081-221
Study First Received: August 20, 2009
Results First Received: December 22, 2011
Last Updated: July 14, 2013
Health Authority: Ministry of Health, Labor and Welfare, Japan (MHLW):

Keywords provided by Eisai Inc.:
Cancer
breast cancer
neoplasm
E7389
Eribulin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014