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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01837095
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Polyphor Ltd.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: POL6326 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2013
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837095


Locations
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United States, Kansas
St Luke's Cancer Institute
Kansas City, Kansas, United States, 64111
United States, Missouri
Washington University School of Medicine, Division of Oncology
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
'Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Weill Cornell Breast Center
New York, New York, United States, 10065
United States, Tennessee
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37232
Spain
Hospital del Mar
Barcelona, Spain, 08003
Hospital Quiron Barcelona
Barcelona, Spain, 08023
Hospital Vall d'Hebrón
Barcelona, Spain, 08035
Instituto Catalàn de Oncologia L'Hospitalet
L'Hospitalet de Llobregat, Spain, 08908
HGUG Marañón
Madrid, Spain, 28007
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital Cinico Universitario de ValenciaValencia
Valencia, Spain, 46010
Sponsors and Collaborators
Polyphor Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Polyphor Ltd.
ClinicalTrials.gov Identifier: NCT01837095    
Other Study ID Numbers: POL-7
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Keywords provided by Polyphor Ltd.:
Overall survival
Progression free survival
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases