Completed
A Phase I Dose Escalation Study of POL6326 With Eribulin in Patients With Relapsed, Triple Negative and Hormone Refractory ER Positive Metastatic Breast Cancer
What is being tested
POL6326
Drug
Who is being recruted
Breast Diseases+3
+ Neoplasms
+ Neoplasms by Site
From 18 to 55 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: June 2013
Summary
Principal SponsorPolyphor Ltd.
Last updated: September 14, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2013
Actual date on which the first participant was enrolled.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
Principal SponsorPolyphor Ltd.
Last updated: September 14, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
54 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms
Criteria
7 inclusion criteria required to participate
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
HER2 negative (IHC 0,1 or FISH HER2:CEP17 ratio < 2.0)
Histologically confirmed invasive cancer of the breast
Show More Criteria
9 exclusion criteria prevent from participating
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
Known HIV positivity on combination antiretroviral therapy; these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
Peripheral neuropathy > Grade 2
Pregnant or breastfeeding
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalPOL6326 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
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 12 locations
Washington University School of Medicine, Division of Oncology
St Louis, United States'Dartmouth-Hitchcock Medical Center
Lebanon, United StatesWeill Cornell Breast Center
New York, United StatesCompleted12 Study Centers