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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: POL6326


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POL6326<br>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 | Drug: POL6326<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of POL6326 in combination with eribulin in patients with metastatic breast cancer | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate of treatment with POL6326 and eribulin in patients with metastatic breast cancer | Determination of the complete response (CR) and partial response (PR) in patients treated with the combination of POL6326 and eribulin | 12-24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overall survival, Progression free survival