A Study of E7389 in Advanced/Metastatic Breast Cancer Patients

NCT00097721 | Completed Phase 2 Results

• 1 other identifier: E7389-A001-201
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 16

Brief Summary

The purpose of this study is to determine if E7389 is a safe and effective treatment for advanced/metastatic breast cancer.

Conditions

Breast Neoplasms

Keywords

breast neoplasm; breast cancer; breast tumor

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)

  Defined as the percentage of subjects with CR or PR from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).

  Confirmed 4 to 8 weeks after first observed

Secondary Outcomes (4)

• Duration of Response

  From CR or partial response PR (whichever recorded first) to date of recurrent or progressive disease

• Progression Free Survival

  From start of study drug administration to progressive disease or death

• Overall Survival

  From start of study drug administration to death

• Change From Baseline to Study Termination in Quality of Life Measures Using Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores

  At Screening, Day 1 of each cycle, and 30 days after last dose of study drug

Study Arms (1)

E7389

EXPERIMENTAL

Drug: E7389

Interventions

E7389 DRUG

The first cohort of subjects were to receive E7389 1.4 mg/m\^2 as an intravenous (IV) bolus on Days 1, 8, and 15 of a 28-day cycle. A second cohort of subjects was added and were to receive E7389 1.4 mg/m\^2 as an IV bolus on Days 1 and 8 of a 21-day cycle.

E7389

Eligibility Criteria

• Age: 18 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 carcinoma of the breast
• Patients with advanced/metastatic disease that is not amenable to curative therapy (either surgery or radiation therapy)
• Patients must have measurable disease by the RECIST criteria, defined as at least one lesion that can be accurately measured in at least one diameter (at least 10 mm in longest diameter (LD) by spiral computer tomography (CT) scan, or at least 20 mm by standard techniques; If the only measurable lesion is a lymph node, it must measure at least 20 mm in LD. If a single lesion is identified as the target lesion, a cytological or histological confirmation of breast carcinoma is required.
• Patients must have had prior treatment with an anthracycline and a taxane (either sequential or in combination) and may have had prior treatment with other agents as well.
• Patients must have progressed within six months of the last dose of chemotherapy, or experienced disease progression while receiving chemotherapy for advanced/metastatic disease.
• Resolution of all chemotherapy or radiation-related toxicities to less than grade 1 severity
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status (APPENDIX 4) of 0 or 1
• Life expectancy of ≥ 3 months
• Adequate renal function as evidenced by serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 50 mL/minute (min) per the Cockcroft and Gault formula
• Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, hemoglobin ≥ 10.0 g/dL (a hemoglobin \<10.0 g/dL would be acceptable if it can be corrected by growth factor or transfusion), and platelet count ≥ 100 x 10\^9/L
• Adequate liver function as evidenced by bilirubin ≤ 1.5 mg/dL and alkaline phosphatase, alanine transaminase (ALT), and aspartate transaminase (AST) ≤ 3 times the upper limits of normal (ULN) (in the case of liver metastases ≤ 5 x ULN)
• Patients willing and able to complete the FACT-B questionnaire, Analgesic Diary, Pain VAS, and the tumor-related symptomatic assessment
• Patients willing and able to comply with the study protocol for the duration of the study
• A sample from the diagnostic biopsy (paraffin block) must be available

You may not qualify if:

• Patients who have received chemotherapy, radiation, hormonal therapy, or Herceptin within 2 weeks of E7389 treatment start
• Radiation therapy encompassing \> 10% of marrow
• Failure to recover from any chemotherapy related or other therapy related toxicity at study entry that is deemed to be clinically significant by the study investigator
• Prior treatment with Mitomycin C or nitrosoureas
• Prior high dose chemotherapy with hematopoietic stem cell rescue in the past two years
• Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen
• Active symptomatic brain metastasis; Patients with central Nervous System (CNS) metastasis are considered eligible if they have completed local therapy and discontinued from corticosteroids for at least two weeks before starting treatment with E7389
• Patients with meningeal carcinomatosis
• Patients who require therapeutic anti-coagulant therapy with Warfarin or related compounds; Mini dose warfarin for catheter related thrombosis prophylaxis is permitted
• Women who are pregnant or breast-feeding; Women of childbearing potential with either a positive pregnancy test at Screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
• Severe /uncontrolled intercurrent illness/infection
• Significant cardiovascular impairment (history of congestive heart failure \> NYHA grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia)
• Patients with organ allografts
• Patients with known positive HIV status
• Patients who have had a prior malignancy, other than carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated ≥ 5 years previously with no subsequent evidence of recurrence

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (16)

Unknown Facility

Jonesboro, Arkansas, United States

Location

Unknown Facility

Deer Park, California, United States

Location

Unknown Facility

La Verne, California, United States

Location

Unknown Facility

Pasadena, California, United States

Location

Unknown Facility

Pomona, California, United States

Location

Unknown Facility

Brooksville, Florida, United States

Location

Unknown Facility

New Port Richey, Florida, United States

Location

Unknown Facility

Plantation, Florida, United States

Location

Unknown Facility

New Orleans, Louisiana, United States

Location

Unknown Facility

Southaven, Mississippi, United States

Location

Unknown Facility

Missoula, Montana, United States

Location

Unknown Facility

Syracuse, New York, United States

Location

Unknown Facility

Middletown, Ohio, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Amarillo, Texas, United States

Location

Unknown Facility

Richardson, Texas, United States

Location

Related Publications (1)

• Muss H, Cortes J, Vahdat LT, Cardoso F, Twelves C, Wanders J, Dutcus CE, Yang J, Seegobin S, O'Shaughnessy J. Eribulin monotherapy in patients aged 70 years and older with metastatic breast cancer. Oncologist. 2014 Apr;19(4):318-27. doi: 10.1634/theoncologist.2013-0282. Epub 2014 Mar 28.

  PMID: 24682463 DERIVED

Related Links

• Official company website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Eisai Call Center
• Organization: Eisai Inc

888-422-4743

Study Officials

• Dale Shuster, Ph.D.

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 29, 2004
• First Posted: November 30, 2004
• Study Start: September 1, 2004
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: April 22, 2013
• Results First Posted: March 15, 2013

Record last verified: 2013-04

Locations

US (16)