A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Patients With Advanced Breast Cancer - Full Text View

Purpose

The purpose of this study in patients with advanced breast cancer is to compare the incidence and severity of neuropathy adverse events for the two treatment groups (eribulin versus ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) grading.

Condition	Intervention	Phase
Breast Cancer	Drug: eribulin mesylate Drug: ixabepilone	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II, Multicenter, Randomized, Open-Label Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Patients With Advanced Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Ixabepilone Eribulin Eribulin mesylate

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Percent of subjects with neuropathy adverse events (AEs) graded according to NCI CTCAE (version 3.0) and coded according to the current version of Medical Dictionary for Regulatory Activities (MedDRA). [ Time Frame: Neuropathy assessments are performed at the start of Cycles 2-6 and subsequently at every third cycle, end-of-treatment visit, and post-treatment follow-up. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Neuropathy assessed by patient neurotoxicity questionnaire and vibration sensibility. [ Time Frame: Assessments are performed at the start of Cycles 2-6 and every third cycle, end-of-treatment visit, and post-treatment follow-up. ] [ Designated as safety issue: Yes ]
Incidence of myalgia/arthralgia AEs. [ Time Frame: From the time subject is consented to when she completes the either 21 day or 42 day post-treatment follow-up visit. ] [ Designated as safety issue: Yes ]
General safety assessed by monitoring all AEs and serious AEs, laboratory measurements, vital signs, and physical exams. [ Time Frame: Safety is assessed from the time subject is consented to when she completes the either 21 day or 42 day post-treatment follow-up visit. ] [ Designated as safety issue: Yes ]
Objective response rate, clinical benefit rate and progression-free survival based on investigator assessments according to Response Evaluation Criteria in Solid Tumors (RECIST). [ Time Frame: At Baseline, at the end of Cycles 2, 4 and 6, subsequently at the end of every third cycle, at the end-of-treatment, and at the post-treatment follow-up. ] [ Designated as safety issue: No ]

Estimated Enrollment:	98
Study Start Date:	March 2009
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: eribulin mesylate E7389 (eribulin mesylate) given at a dose of 1.4 mg/m^2 as a 2 - 5 minute intravenous (IV) bolus on Days 1 and 8 of a 21-day cycle. The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment. Other Name: E7389
Active Comparator: 2	Drug: ixabepilone Ixabepilone given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle. The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

1. Female subjects with confirmed locally recurrent or metastatic carcinoma of the breast who have received prior taxane therapy and at least one prior cytotoxic chemotherapy regimen for advanced disease.

Exclusion criteria:

Subjects who have received prior ixabepilone therapy.
Subjects with prior participation in an eribulin clinical study, even if not assigned to eribulin treatment.
Subjects with pre-existing neuropathy Grade ≥ 2.
Subjects with a history of diabetes mellitus Type 1 or 2.
Subjects with bilateral mastectomy which included bilateral axillary lymph node dissection.
Subjects with 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879086

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Sponsors and Collaborators

Eisai Inc.

More Information

No publications provided

Responsible Party:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00879086 History of Changes
Other Study ID Numbers:	E7389-G000-209
Study First Received:	April 8, 2009
Last Updated:	September 5, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eisai Inc.:

Breast Cancer
Oncology

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epothilones
Tubulin Modulators

Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013