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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837095
• Other study ID #: POL-7
• Status: Completed
• Phase: Phase 1
• Start date: June 2013
• Est. completion date: August 2018

Study information

• Verified date: September 2018
• Source: Polyphor Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona
Spain	Hospital Quiron Barcelona	Barcelona
Spain	Hospital Vall d'Hebrón	Barcelona
Spain	Instituto Catalàn de Oncologia L'Hospitalet	L'Hospitalet de Llobregat
Spain	HGUG Marañón	Madrid
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Cinico Universitario de ValenciaValencia	Valencia
United States	St Luke's Cancer Institute	Kansas City	Kansas
United States	'Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Vanderbilt University School of Medicine	Nashville	Tennessee
United States	Weill Cornell Breast Center	New York	New York
United States	Washington University School of Medicine, Division of Oncology	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Polyphor Ltd.

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Response rate of treatment with POL6326 and eribulin in patients with metastatic breast cancer	Determination of the complete response (CR) and partial response (PR) in patients treated with the combination of POL6326 and eribulin	12-24 months