Clinical Trials /

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

NCT01837095

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: POL-7
  • NCT ID: NCT01837095

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
POL6326POL6326

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

Trial Arms

NameTypeDescriptionInterventions
POL6326ExperimentalPOL6326 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
  • POL6326

Eligibility 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
      
Maximum Eligible Age:55 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and tolerability of POL6326 in combination with eribulin in patients with metastatic breast cancer
Time Frame:6 months
Safety Issue:
Description: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

Measure:Response rate of treatment with POL6326 and eribulin in patients with metastatic breast cancer
Time Frame:12-24 months
Safety Issue:
Description:Determination of the complete response (CR) and partial response (PR) in patients treated with the combination of POL6326 and eribulin

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Polyphor Ltd.

Trial Keywords

  • Overall survival
  • Progression free survival

Last Updated

January 31, 2017