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
1 other identifier
interventional
54
2 countries
12
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2013
Longer than P75 for phase_1
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2013
CompletedFirst Posted
Study publicly available on registry
April 22, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedSeptember 14, 2018
September 1, 2018
5.2 years
April 2, 2013
September 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of POL6326 in combination with eribulin in patients with metastatic breast cancer
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
6 months
Secondary Outcomes (1)
Response rate of treatment with POL6326 and eribulin in patients with metastatic breast cancer
12-24 months
Study Arms (1)
POL6326
EXPERIMENTALPOL6326 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Polyphor Ltd.lead
Study Sites (12)
St Luke's Cancer Institute
Kansas City, Kansas, 64111, United States
Washington University School of Medicine, Division of Oncology
St Louis, Missouri, 63110, United States
'Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Weill Cornell Breast Center
New York, New York, 10065, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, 37232, United States
Hospital del Mar
Barcelona, 08003, Spain
Hospital Quiron Barcelona
Barcelona, 08023, Spain
Hospital Vall d'Hebrón
Barcelona, 08035, Spain
Instituto Catalàn de Oncologia L'Hospitalet
L'Hospitalet de Llobregat, 08908, Spain
HGUG Marañón
Madrid, 28007, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital Cinico Universitario de ValenciaValencia
Valencia, 46010, Spain
Related Publications (1)
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.
PMID: 29706375DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2013
First Posted
April 22, 2013
Study Start
June 1, 2013
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
September 14, 2018
Record last verified: 2018-09