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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Polyphor Ltd.
Sponsor:
Information provided by (Responsible Party):
Polyphor Ltd.
ClinicalTrials.gov Identifier:
NCT01837095
First received: April 2, 2013
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Metastatic Breast Cancer
Drug: POL6326
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Polyphor Ltd.:

Primary Outcome Measures:
  • Safety and tolerability of POL6326 in combination with eribulin in patients with metastatic breast cancer [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Response rate of treatment with POL6326 and eribulin in patients with metastatic breast cancer [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]
    Determination of the complete response (CR) and partial response (PR) in patients treated with the combination of POL6326 and eribulin


Estimated Enrollment: 24
Study Start Date: June 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01837095

Contacts
Contact: Foluso O Ademuyiwa, M.D. (314) 362-7201 fademuyi@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine, Division of Oncology Recruiting
St. Louis, Missouri, United States, 63110
Contact: Foluso O Ademuyiwa, M.D.    314-362-7201    fademuyi@dom.wustl.edu   
Principal Investigator: Foluso O Ademuyiwa, M.D.         
Sponsors and Collaborators
Polyphor Ltd.
  More Information

No publications provided

Responsible Party: Polyphor Ltd.
ClinicalTrials.gov Identifier: NCT01837095     History of Changes
Other Study ID Numbers: POL-7
Study First Received: April 2, 2013
Last Updated: November 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Polyphor Ltd.:
Overall survival
Progression free survival

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014