Eribulin Mesylate Phase IV Clinical Trial in Korean Patients With Metastatic or Locally Advanced Breast Cancer

NCT01961544 | Completed Phase 4 Results

• 1 other identifier: EKI-CT-1301
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 14

Brief Summary

This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of eribulin which is approved for the treatment of the patients in Korea with locally advanced or metastatic breast cancer who had received two to five prior chemotherapy regimens including anthracyclines and taxanes for advanced disease. Subjects who meet the inclusion/exclusion criteria are administered of 1.4 mg/m2 of the investigational product intravenously in 2-5 min on day 1 and day 8 of every 21-day cycle. In case of the progression of disease, unacceptable toxicity, withdrawal of the consent, or judgment by investigator that the treatment needs to be stopped, the treatment of investigational product is stopped, and treatment termination assessment is performed within 30 days from the last treatment.

Conditions

Breast Neoplasms; Breast Cancer

Keywords

Breast Cancer; Metastatic

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-emergent Serious Adverse Event (SAE)

  An AE is defined as any harmful, untoward sign (including abnormal laboratory value, etc.), symptom, or disease in a participant administered investigational product that does not necessarily have a causal relationship with treatment. An SAE is defined as an AE that is life threatening or results in death, results in hospitalization (initial or prolonged), results in a disability (significant, persistent, or permanent change, impairment, damage or disruption in the participant's body function/structure, physical activities, or quality of life), results in a congenital anomaly, or requires intervention to prevent permanent impairment or damage. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.

  mean of 3.76 months

Secondary Outcomes (1)

• Disease Control Rate (DCR)

  mean of 3.76 months

Study Arms (1)

Eribulin mesylate

EXPERIMENTAL

1.4 mg/m2 (as eribulin 1.23 mg/m2) day by 2-5 minutes IV on Day 1 and 8 every 21 days

Drug: Eribulin mesylate

Interventions

Eribulin mesylate DRUG

1.4 mg/m2 (as eribulin 1.23 mg/m2) day by 2-5 minutes IV on Day 1 and 8 every 21 days

Eribulin mesylate

Eligibility Criteria

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

You may qualify if:

• Female, Age greater or equal to 20 years
• Patients with histologically or cytologically confirmed carcinoma of the breast
• Patients with locally advance or metastatic carcinoma of the breast
• Patients who have received two to five prior chemotherapeutic regimens including an antracycline and a taxane and 2 or more regimens for locally recurrent and/or metastatic disease
• Patients must have proved refractory to the most recent chemotherapy on or within six (6) months of therapy
• Patients who have assessable lesion according to RECIST v 1.1
• Adequately maintained bone marrow function
• absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9 /L
• hemoglobin greater than or equal to 10.0 g/dl (a hemoglobin less than 10.0 g/dL is acceptable if it is corrected by erythropoietin or transfusion)
• Platelet count greater than or equal to 100 x 10\^9 /L
• Adequately maintained liver function
• Total bilirubin: less than or equal to 1.5 times the upper limits of normal (ULN) and
• Alkaline phosphatase(ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 x ULN (in the case of liver metastases less than or equal to 5 x ULN)
• Adequately maintained renal function
• Serum creatinine less than or equal to 2.0 mg/dl or

You may not qualify if:

• Patients who have received a chemotherapy, radiation, biologics, immunotherapy or hormonal therapy within three weeks before treatment start (but, palliative radiation can be enrolled)
• Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen
• Patients 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 four weeks before starting treatment in this study. Any signs and/or symptoms of brain metastases must be stable for at least four weeks before starting study treatment
• Patients with meningeal carcinomatosis
• Significant cardiovascular impairment
• Myocardial infarction within the past six months, unstable angina, history of congestive heart failure NYHA class III or IV, or serious cardiac arrhythmia
• QTc prolongation (Bazett's Formula greater than 480 msec) or congenital long QT syndrome
• Severe/uncontrolled intercurrent illness/infection required administration of antibiotic injection
• Patients who have processed a major surgery within four weeks before participation in this clinical trial
• Patients who have had a prior malignancy within the past five years other than breast cancer (but, treated non-melanoma skin cancer and carcinoma in situ of the cervix will not be excluded)
• Patients with known positive HIV status
• Patients who have received genetic therapy or other investigational drug within 4 weeks before treatment start or expected to receive prohibited medication
• Patients with prior allergies to Halichondrin B, its derivatives, active ingredient, or other diluting agent
• Patients who have received this investigational product before registration for this study
• Patients who are pregnant, who may possibly be pregnant, or are lactating

Sponsors & Collaborators

• Eisai Korea Inc.: lead

Study Sites (14)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 443-380, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 361-711, South Korea

Location

Dong-A University Hospital

Busan, 602-715, South Korea

Location

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Severance Hospital

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Ulsan University Hospital

Ulsan, 682-714, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Eisai Medical Services
• Organization: Eisai Inc.

1-888-422-4743

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 7, 2016
• Results First Posted: October 7, 2016

Record last verified: 2016-08

Locations

KR (14)