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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2018-08-31

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

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Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

POL6326

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No