Study of E7389 for Advanced or Metastatic Breast Cancer

NCT00965523 | Completed Phase 2 Results

• 2 other identifiers: E7389-J081-224E7389-J081-221
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Cancer; breast cancer; neoplasm; E7389; Eribulin

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Adverse Events.

  Every week during treatment and up to 30 days after last dose of study treatment

Secondary Outcomes (1)

• Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)

  Every 6 weeks

Study Arms (1)

Eribulin Mesylate

EXPERIMENTAL

Drug: Eribulin Mesylate

Interventions

Eribulin Mesylate DRUG

Eribulin mesylate 1.4 mg/m\^2 intravenous infusion (IV) given over 2 to 5 minutes on Day 1 and 8 every 21 days.

Eribulin Mesylate

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with histologically or cytologically confirmed breast cancer.
• Patients who have received prior chemotherapy including anthracycline and taxane.
• 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.
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
• Patients with a measurable lesion.
• Patients with an expected survival of ≥ 3 months from the start of study drug therapy.
• Female patients in whom continued administration of E7389 following Study 221 will be useful.
• Patients who have met the criteria for starting the next cycle in Study 221.
• Namely, patients who meet all of the following criteria:
• Neutrophil count \>= 1,500 /µL
• Platelet count \>= 100,000 /µL
• 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)
• Total bilirubin \<= 1.5 times ULN
• Serum creatinine \<= 1.5 times ULN
• Non-hematological toxicity \<= Grade 2 (excluding disease-associated events and laboratory abnormalities without clinical symptoms)

You may not qualify if:

• Patients with systemic infection with a fever (≥38.0°C).
• Patients with pleural effusion, ascites or pericardial fluid requiring drainage.
• Patients with brain metastasis presenting clinical symptoms.
• 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.
• Patients with serious complications:
• 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)
• Patients with myocardial infarction within 6 months prior to study entry
• Patients with a complication of hepatic cirrhosis
• Patients with interstitial pneumonia and pulmonary fibrosis
• Patients with a bleeding tendency
• Patients with an active double cancer.
• Pregnant women or nursing mothers.
• Patients who have received extensive radiotherapy (≥30% of bone marrow).
• Patients who refuse to receive the supportive therapy of blood transfusion for myelosuppression.
• Patients who are participating in other clinical studies.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (5)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Kure, Hiroshima, Japan

Location

Unknown Facility

Kagoshima, Kagoshima-ken, Japan

Location

Unknown Facility

Chūō, Tokyo, Japan

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Tatsuo Watanabe, Study Director
• Organization: Eisai

+81-3-3817-5252

Study Officials

• Tatsuo Watanabe

  Oncology Clinical Development Section. JAC PCU., Eisai, Co., Ltd

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 25, 2009
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: August 15, 2013
• Results First Posted: August 15, 2013

Record last verified: 2013-07

Locations

JP (5)