Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE April 2, 2013
First Posted Date  ICMJE April 22, 2013
Last Update Posted Date September 14, 2018
Study Start Date  ICMJE June 2013
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer
Official Title  ICMJE A Phase I Dose Escalation Study of POL6326 With Eribulin in Patients With Relapsed, Triple Negative and Hormone Refractory ER Positive Metastatic Breast Cancer
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE 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
Study Arms  ICMJE 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
Publications * Pernas S, Martin M, Kaufman PA, Gil-Martin M, Gomez Pardo P, Lopez-Tarruella S, Manso L, Ciruelos E, Perez-Fidalgo JA, Hernando C, Ademuyiwa FO, Weilbaecher K, Mayer I, Pluard TJ, Martinez Garcia M, Vahdat L, Perez-Garcia J, Wach A, Barker D, Fung S, Romagnoli B, Cortes J. Balixafortide plus eribulin in HER2-negative metastatic breast cancer: a phase 1, single-arm, dose-escalation trial. Lancet Oncol. 2018 Jun;19(6):812-824. doi: 10.1016/S1470-2045(18)30147-5. Epub 2018 Apr 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2017)
54
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2013)
24
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01837095
Other Study ID Numbers  ICMJE POL-7
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Polyphor Ltd.
Study Sponsor  ICMJE Polyphor Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Polyphor Ltd.
Verification Date September 2018

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