Status:
COMPLETED
Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer
Lead Sponsor:
Polyphor Ltd.
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18-55 years
Phase:
PHASE1
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 inve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01837095
Start Date
June 1 2013
End Date
August 1 2018
Last Update
September 14 2018
Active Locations (12)
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1
St Luke's Cancer Institute
Kansas City, Kansas, United States, 64111
2
Washington University School of Medicine, Division of Oncology
St Louis, Missouri, United States, 63110
3
'Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
4
Weill Cornell Breast Center
New York, New York, United States, 10065