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

September 13, 2018 updated by: Polyphor Ltd.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08023
        • Hospital Quirón Barcelona
      • L'Hospitalet de Llobregat, Spain, 08908
        • Instituto Catalán de Oncología L'Hospitalet
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28007
        • HGUG Marañón
      • Valencia, Spain, 46010
        • Hospital Cinico Universitario de ValenciaValencia
  • United States
    • Kansas
      • Kansas City, Kansas, United States, 64111
        • St Luke's Cancer Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine, Division of Oncology
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • 'Dartmouth-Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Breast Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
12-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Polyphor Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (Estimate)

April 22, 2013

Study Record Updates

Last Update Posted (Actual)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POL-7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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