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Details for trial 1B-09-1

Description:	A Phase II, Multi-Center, Randomized, Open-Label Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Patients With Advanced Breast Cancer.
Status:	Closed
Randomized?	No

Researchers

Principal Investigator	Title
Agustin Garcia	M.D.

Data Management

Name	Title
Kristy Watkins	R.N.
Nancy Perez	R.N.
Yvonne Flores	D.M.
Anayansi Miloud	D.M.

You may participate in this study if:

	Requirement
1	Subjects must be female and have histologically or cytologically confirmed carcinoma of the breast (locally recurrent or metastatic disease).
2	Subjects must have had prior taxane therapy.
3	Subjects must have received at least one prior cytotoxic chemotherapy regimen for locally recurrent or metastatic breast cancer.
4	Subjects must have progressed while on or after their last anti-cancer therapy.
5	Subjects must show resolution of all chemotherapy or radiation-related toxicities to Grade less than or equal to 1, except for alopecia.
6	Subjects must be greater than or equal to 18 years old.
7	Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
8	Subjects must have adequate renal function as evidenced by serum creatinine less than or equal to 2.0 or calculated creatinine clearance greater than or equal to 40 mL/min per the Cockcroft and Gault formula.
9	Subjects must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) greater than or equal to 1,500; hemoglobin greater than or equal to 10.0 (a hemoglobin < 10.0 is acceptable if it is corrected by growth factor or transfusion); and platelet count greater than or equal to 100,000.
10	Subjects must have adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limit of the normal range (ULN), and alkaline phosphatase, 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). If there are bone metastases, liver-specific alkaline phosphatase may be separated from the total and used to assess liver function instead of total alkaline phosphatase.
11	Subjects must be willing and able to comply with the study protocol for the duration of the study, including being able to complete the Patient Neurotoxicity Questionnaire (PNQ) without the assistance of study site personnel.
12	Patient must have signed and dated IRB approved informed consent and HIPAA authorization forms.

You may not participate in this study if:

1	Subjects who have received prior ixabepilone therapy
2	Subjects with prior participation in an eribulin clinical study, even if not previously assigned to eribulin treatment
3	Subjects with pre-existing neuropathy Grade greater than or equal to 2.
4	Subjects with a history of diabetes mellitus Type 1 or 2. Transient hyperglycemia, eg due to corticosteroid therapy, does not exclude a subject from this study.
5	Subjects who have received any of the following treatments within the specified period before the start of treatment: • Chemotherapy, radiation, or biological or targeted therapy within 2 weeks • Hormonal therapy within 1 week • Any investigational drug within 4 weeks
6	Subjects with pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
7	Subjects with brain or subdural metastases, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (eg, radiologic) and/or symptoms of brain metastases must be stable for at least 8 weeks with radiographic stability proven by at least 2 contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) scans obtained at least 8 weeks apart, with the most recent scan obtained within 28 days of the first infusion of study drug.
8	Subjects with meningeal carcinomatosis
9	Subjects with bilateral mastectomy which included bilateral axillary lymph node dissection. Subjects missing digits required for vibration assessment. Subjects with any other concurrent diseases or conditions that would be expected to interfere with neuropathy assessments, which may include vitamin deficiency, sequelae of cerebrovascular disease, thyroid insufficiency, lumbar or cervical radiculopathy, or alcoholic or inflammatory neuropathy.
10	Female subjects of childbearing potential must agree to be abstinent or to use two highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomized partner), starting at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception.
11	Subjects with severe or uncontrolled intercurrent illness or infection
12	Subjects with significant cardiovascular impairment (history of congestive heart failure > New York Heart Association (NYHA) Grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia)
13	Subjects with organ allografts requiring immunosuppression
14	Subjects with known positive human immunodeficiency virus (HIV) status, because the neutropenia caused by the study treatments may make such subjects particularly susceptible to infection.
15	Subjects 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 greater than or equal to 5 years previously with no subsequent evidence of recurrence.
16	Subjects with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.
17	Subjects with a history of a severe (Grade 3/4) hypersensitivity reaction to agents containing Cremophor® EL or its derivatives (eg, polyoxyethylated castor oil), or who have experienced Grade 1 or 2 reactions to Cremophor and, in the investigator’s judgment, should not be re-exposed to Cremophor. Since this hypersensitivity is a contraindication for the comparator product, these subjects would not be able to receive the comparator product and therefore will not be able to undergo randomization.
18	Subjects with other significant disease or disorders that, in the investigator’s opinion, would exclude the subject from the study.

For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.