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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT01837095 (opens ClinicalTrials.gov in a new tab)Other idPOL-7
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
54 participants (actual)
Sponsor
Polyphor Ltd. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
2 countries

United States, Spain

Start
Jun 2013
Primary completion
Aug 2018
Completion
Aug 2018
First posted
22 Apr 2013 (estimated)
Last update posted
14 Sept 2018
Conditions
Metastatic Breast Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016201720182019
  1. Ph 1

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

    NCT01837095

    Jun 2013 to Aug 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • POL6326Drug

Arms1

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Safety and tolerability of POL6326 in combination with eribulin in patients with metastatic breast cancer

    Time frame · 6 months

    Registry 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 outcomes(1)

  1. Response rate of treatment with POL6326 and eribulin in patients with metastatic breast cancer

    Time frame · 12-24 months

    Registry description

    Determination of the complete response (CR) and partial response (PR) in patients treated with the combination of POL6326 and eribulin

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2018

18 results

Balixafortide plus eribulin in HER2-negative metastatic breast cancer: a phase 1, single-arm, dose-escalation trial.

Pernas et al. 2018The Lancet. Oncologycited by 116

PMID 29706375DOI 10.1016/s1470-2045(18)30147-5PUB-29706375

Full text at the publisher18 results
Publisher pageSee results (18)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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