Clinical trial NCT01837095: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Keywords: Overall survival
Progression free survival
Lead sponsor: Polyphor Ltd.
Sponsor class: INDUSTRY
First posted: 2013-04-22
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Safety and tolerability of POL6326 in combination with eribulin in patients with metastatic breast cancer
timeFrame: 6 months
Secondary outcomes:
measure: Response rate of treatment with POL6326 and eribulin in patients with metastatic breast cancer
timeFrame: 12-24 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: St Luke's Cancer Institute
state: Kansas
city: Saint Louis
country: United States
facility: Washington University School of Medicine, Division of Oncology
state: Missouri
city: Lebanon
country: United States
facility: 'Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Weill Cornell Breast Center
state: New York
city: Nashville
country: United States
facility: Vanderbilt University School of Medicine
state: Tennessee
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Quiron Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebrón
city: L'Hospitalet de Llobregat
country: Spain
facility: Instituto Catalàn de Oncologia L'Hospitalet
city: Madrid
country: Spain
facility: HGUG Marañón
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Cinico Universitario de ValenciaValencia
Study officials:
References:
citation: 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.