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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00879086
First received: April 8, 2009
Last updated: July 22, 2014
Last verified: July 2014
  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:


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 ]

Enrollment: 104
Study Start Date: March 2009
Study Completion Date: April 2014
Primary Completion Date: April 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:

  1. Subjects who have received prior ixabepilone therapy.
  2. Subjects with prior participation in an eribulin clinical study, even if not 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.
  5. Subjects with bilateral mastectomy which included bilateral axillary lymph node dissection.
  6. Subjects with missing digits required for vibration assessment.
  7. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 50 Study Locations
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: July 22, 2014
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

ClinicalTrials.gov processed this record on September 18, 2014