Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer
Conditions
Metastatic Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Overall survival, Progression free survival
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: POL6326
Type: Drug
Overall Status
Recruiting
Summary
POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin. Different doses and dosing frequencies will be investigated
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 55 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Histologically confirmed invasive cancer of the breast.

- Presence of at least one measurable lesion per RECIST 1.1 criteria

- Stage IV disease by AJCC criteria (7th edition).

- HER2 negative (IHC 0,1 or FISH HER2:CEP17 ratio < 2.0)

- Must have had treatment with at least 2 but no more than 3 previous regimens in the metastatic setting. Previous treatment must have included an anthracycline and taxane in either the adjuvant or metastatic setting.

- At least 21 days from the completion of any previous cytotoxic chemotherapy or biological therapy at time of initiation of POL6326.

- ECOG performance status < 2

Exclusion Criteria:

- Previously received eribulin.

- Peripheral neuropathy > Grade 2.

- Receipt of any other investigational agent within the 28 days prior to Day 1.

- Receipt of colony stimulating factor filgrastim, pegfilgrastim, or sargramostim within 14 days prior to Day 1.

- Radiation therapy within the 14 days prior to Day 1.

- Severe concurrent illness or psychiatric illness/social situation that would limit compliance with study requirements.

- History of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.

- Pregnant or breastfeeding.

- Known HIV positivity on combination antiretroviral therapy; these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
Locations
St Luke's Cancer Institute
Kansas City, Missouri, United States
Status: Not yet recruiting
Washington University School of Medicine, Division of Oncology
St. Louis, Missouri, United States
Status: Active, not recruiting
'Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Status: Recruiting
Weill Cornell Breast Center
New-York, New York, United States
Status: Not yet recruiting
Vanderbilt University School of Medicine
Nashville, Tennessee, United States
Status: Recruiting
Hospital del Mar
Barcelona, Spain
Status: Recruiting
Hospital Quiron Barcelona
Barcelona, Spain
Status: Recruiting
Hospital Vall d'Hebrón
Barcelona, Spain
Status: Recruiting
Instituto Catalàn de Oncologia L'Hospitalet
L'Hospitalet de Llobregat, Spain
Status: Recruiting
HGUG Marañón
Madrid, Spain
Status: Recruiting
Hospital 12 de Octubre
Madrid, Spain
Status: Recruiting
Hospital Cinico Universitario de ValenciaValencia
Valencia, Spain
Status: Recruiting
Start Date
June 2013
Completion Date
December 2016
Sponsors
Polyphor Ltd.
Source
Polyphor Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page