Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer
Completed · Phase 1
Conditions studied: Metastatic Breast Cancer
In brief
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
Key facts
- Study ID
- NCT01837095
- Run by
- Polyphor Ltd.
- People needed
- 54
- Starts
- 2013-06-01
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2018-09-14
Who can join
Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- St Luke's Cancer Institute — Kansas City, Kansas, United States
- Washington University School of Medicine, Division of Oncology — St Louis, Missouri, United States
- 'Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
- Weill Cornell Breast Center — New York, New York, United States
- Vanderbilt University School of Medicine — Nashville, Tennessee, United States
- Hospital del Mar — Barcelona, Spain
- Hospital Quiron Barcelona — Barcelona, Spain
- Hospital Vall d'Hebrón — Barcelona, Spain
- Instituto Catalàn de Oncologia L'Hospitalet — L'Hospitalet de Llobregat, Spain
- HGUG Marañón — Madrid, Spain
- Hospital 12 de Octubre — Madrid, Spain
- Hospital Cinico Universitario de ValenciaValencia — Valencia, Spain
Full record on ClinicalTrials.gov
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