Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 55
Updated:9/16/2018
Start Date:June 2013
End Date:August 2018

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A Phase I Dose Escalation Study of POL6326 With Eribulin in Patients With Relapsed, Triple Negative and Hormone Refractory ER Positive Metastatic Breast Cancer

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


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
We found this trial at
6
sites
Kansas City, Kansas 64111
196
mi
from
Kansas City, KS
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Barcelona, 08003
5005
mi
from
Barcelona,
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
1393
mi
from
Lebanon, NH
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Nashville, Tennessee 37232
618
mi
from
Nashville, TN
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New York, New York 10065
1286
mi
from
New York, NY
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418
mi
from
Saint Louis, MO
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