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Continuation Study of E7389 for Advanced or Relapsed 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: October 10, 2011
Last verified: October 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the safety of patients who continue to receive E7389 after completing the Phase II clinical study of E7389 for advanced or relapsed breast cancer by intravenously administering E7389.


Condition Intervention Phase
Breast Cancer
 Drug: E7389
 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 Continuation Study of E7389 for Advanced or Relapsed Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Occurrence of adverse events, changes in physical examination findings, laboratory test results, vital signs, and electrocardiogram evaluations. [ Time Frame: Every week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) and duration of overall response [ Time Frame: Every 6 Weeks ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: August 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E7389 1.4 mg/m2 Drug: E7389
E7389 1.4 mg/m2 is administrated intravenously. In this study, the initial dose will be administered within 14 days after Day 22 of the last cycle in the preceding study. One cycle will consist of 21 days, and in each cycle E7389 will be administered on Days 1 and 8 and withdrawn on Day 15.

Detailed Description:

During the period of E7389 administration, the following items will be examined to evaluate the safety of E7389: signs and symptoms, clinical laboratory parameters, chest x-ray findings, 12-lead ECG, vital signs, body weight, and adverse events. To evaluate the efficacy of E7389, tumor lesions will be observed and tumor markers will be examined.

  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 in whom continued administration of E7389 following the preceding study will be useful.
  2. Patients who have given written voluntary consent for participating in this study before the completion of the preceding study.
  3. Patients who have met the criteria for starting the next cycle in the preceding study.

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;

Exclusion criteria:

  1. Patients who are judged by the principal investigator or the other investigators to be inappropriate as patients in this clinical study.
  2. 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.
  Contacts and Locations
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
Study First Received: August 20, 2009
Last Updated: October 10, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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 May 19, 2013