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

Sponsor

Polyphor Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01837095

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Drug: POL6326	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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	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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Safety and tolerability of POL6326 in combination with eribulin in patients with metastatic breast cancer [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

Secondary Outcome Measures

Response rate of treatment with POL6326 and eribulin in patients with metastatic breast cancer [12-24 months]
Determination of the complete response (CR) and partial response (PR) in patients treated with the combination of POL6326 and eribulin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Luke's Cancer Institute	Kansas City	Kansas	United States	64111
2	Washington University School of Medicine, Division of Oncology	Saint Louis	Missouri	United States	63110
3	'Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
4	Weill Cornell Breast Center	New York	New York	United States	10065
5	Vanderbilt University School of Medicine	Nashville	Tennessee	United States	37232
6	Hospital del Mar	Barcelona		Spain	08003
7	Hospital Quiron Barcelona	Barcelona		Spain	08023
8	Hospital Vall d'Hebrón	Barcelona		Spain	08035
9	Instituto Catalàn de Oncologia L'Hospitalet	L'Hospitalet de Llobregat		Spain	08908
10	HGUG Marañón	Madrid		Spain	28007
11	Hospital 12 de Octubre	Madrid		Spain	28041
12	Hospital Cinico Universitario de ValenciaValencia	Valencia		Spain	46010

Sponsors and Collaborators

Polyphor Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Polyphor Ltd.

ClinicalTrials.gov Identifier:

NCT01837095

Other Study ID Numbers:

POL-7

First Posted:

Apr 22, 2013

Last Update Posted:

Sep 14, 2018

Last Verified:

Sep 1, 2018

Keywords provided by Polyphor Ltd.

Overall survival

Progression free survival

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Sep 14, 2018