Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer
- Registration Number
- NCT01837095
- Lead Sponsor
- Polyphor Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 54
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description POL6326 POL6326 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
- Primary Outcome Measures
Name Time Method Safety and tolerability of POL6326 in combination with eribulin in patients with metastatic breast cancer 6 months Incidence and severity of adverse events and serious adverse events of the combination of POL6326 and eribulin when compared to the adverse event profile of eribulin alone
- Secondary Outcome Measures
Name Time Method Response rate of treatment with POL6326 and eribulin in patients with metastatic breast cancer 12-24 months Determination of the complete response (CR) and partial response (PR) in patients treated with the combination of POL6326 and eribulin
Trial Locations
- Locations (12)
Washington University School of Medicine, Division of Oncology
🇺🇸Saint Louis, Missouri, United States
Vanderbilt University School of Medicine
🇺🇸Nashville, Tennessee, United States
HGUG Marañón
🇪🇸Madrid, Spain
Hospital Quiron Barcelona
🇪🇸Barcelona, Spain
Instituto Català n de Oncologia L'Hospitalet
🇪🇸L'Hospitalet de Llobregat, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
'Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
St Luke's Cancer Institute
🇺🇸Kansas City, Kansas, United States
Weill Cornell Breast Center
🇺🇸New York, New York, United States
Hospital Vall d'Hebrón
🇪🇸Barcelona, Spain
Hospital Cinico Universitario de ValenciaValencia
🇪🇸Valencia, Spain