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

This study is currently recruiting participants.
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

April 2, 2013
November 28, 2013
June 2013
December 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01837095 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer
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

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
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
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
Intervention: Drug: POL6326
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
December 2016
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 55 Years
No
Contact: Foluso O Ademuyiwa, M.D. (314) 362-7201 fademuyi@dom.wustl.edu
United States
 
NCT01837095
POL-7
No
Polyphor Ltd.
Polyphor Ltd.
Not Provided
Not Provided
Polyphor Ltd.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP