Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01837095 |
Recruitment Status :
Completed
First Posted : April 22, 2013
Last Update Posted : September 14, 2018
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Breast Cancer | Drug: POL6326 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Dose Escalation Study of POL6326 With Eribulin in Patients With Relapsed, Triple Negative and Hormone Refractory ER Positive Metastatic Breast Cancer |
Study Start Date : | June 2013 |
Actual Primary Completion Date : | August 2018 |
Actual Study Completion Date : | August 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: 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
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Drug: 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 |
- Safety and tolerability of POL6326 in combination with eribulin in patients with metastatic breast cancer [ Time Frame: 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
- Response rate of treatment with POL6326 and eribulin in patients with metastatic breast cancer [ Time Frame: 12-24 months ]Determination of the complete response (CR) and partial response (PR) in patients treated with the combination of POL6326 and eribulin

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837095
United States, Kansas | |
St Luke's Cancer Institute | |
Kansas City, Kansas, United States, 64111 | |
United States, Missouri | |
Washington University School of Medicine, Division of Oncology | |
Saint Louis, Missouri, United States, 63110 | |
United States, New Hampshire | |
'Dartmouth-Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03756 | |
United States, New York | |
Weill Cornell Breast Center | |
New York, New York, United States, 10065 | |
United States, Tennessee | |
Vanderbilt University School of Medicine | |
Nashville, Tennessee, United States, 37232 | |
Spain | |
Hospital del Mar | |
Barcelona, Spain, 08003 | |
Hospital Quiron Barcelona | |
Barcelona, Spain, 08023 | |
Hospital Vall d'Hebrón | |
Barcelona, Spain, 08035 | |
Instituto Catalàn de Oncologia L'Hospitalet | |
L'Hospitalet de Llobregat, Spain, 08908 | |
HGUG Marañón | |
Madrid, Spain, 28007 | |
Hospital 12 de Octubre | |
Madrid, Spain, 28041 | |
Hospital Cinico Universitario de ValenciaValencia | |
Valencia, Spain, 46010 |
Responsible Party: | Polyphor Ltd. |
ClinicalTrials.gov Identifier: | NCT01837095 |
Other Study ID Numbers: |
POL-7 |
First Posted: | April 22, 2013 Key Record Dates |
Last Update Posted: | September 14, 2018 |
Last Verified: | September 2018 |
Overall survival Progression free survival |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |