Status:
COMPLETED
Study of E7389 for Advanced or Metastatic Breast Cancer
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
20-74 years
Phase:
PHASE2
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-J...
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 Perio...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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)
- Exclusion criteria:
- 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.
- Patients who are judged by the principal investigator or the other investigators to be inappropriate as patients in this clinical study.
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00965523
Start Date
January 1 2008
End Date
January 1 2011
Last Update
August 15 2013
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Nagoya, Aichi-ken, Japan
2
Fukuoka, Fukuoka, Japan
3
Kure, Hiroshima, Japan
4
Kagoshima, Kagoshima-ken, Japan