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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03786094
Other study ID # POL6326-009
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date May 30, 2019
Est. completion date October 19, 2021

Study information

Verified date October 2023
Source Spexis AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or Metastatic Breast Cancer.


Recruitment information / eligibility

Status Terminated
Enrollment 432
Est. completion date October 19, 2021
Est. primary completion date October 19, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Histologically confirmed Breast cancer - Metastatic Breast Cancer currently of stage IV disease or unresectable locoregionally recurrent breast cancer - refractory to the most recent chemotherapy, documented by progression on or within six (6) months of therapy - At least 14 days from the completion of any previous cancer therapy - Adequate organ function - Life expectancy of 3 months or more - Willing and able to comply with the protocol and able to understand and willing to sign an informed consent Key Exclusion Criteria: - Previously treated with eribulin - Peripheral neuropathy Grade =3 - Receipt of prior CXCR4 therapy - Receipt of colony stimulating factors (CSFs) filgrastim, pegfilgrastim, or sargramostim, or radiation therapy within 14 days prior to study Day 1 - History of allergic reactions attributed to compounds of similar chemical or biologic composition to balixafortide or eribulin or other agents used in the study - Breast feeding or pregnant - Patients with congestive heart failure, electrolyte abnormalities, bradyarrhythmias, known congenital long QT syndrome, QT interval corrected with Fridericia's formula (QTcF) =470 msec at baseline in the absence of bundle branch block, or currently taking drugs at known risk of prolonging the QT interval or causing torsades de pointes

Study Design


Intervention

Drug:
Eribulin
Eribulin alone
Balixafortide
Balixafortide + Eribulin

Locations

Country Name City State
Argentina Sanatorio Parque de Rosario Rosario Santa Fe
Argentina Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan San Juan Buenos Aires
Argentina CAIPO Centro para la atención integral del paciente oncológico San Miguel De Tucumán
Argentina Centro de Investigación Clínica - Clínica Viedma Viedma Río Negro
Belgium UZ Antwerpen Antwerpen
Belgium CHIREC Centre Hospitalier Interregional Edith Cavell Brussels
Belgium Grand Hopital de Charleroi asbl Charleroi Hainaut
Belgium UZ Gent Gent
Belgium CHU de Liège Liège
Brazil Centro de Oncologia Da Bahia Bahia
Brazil Universidade de Caxias do Sul (IPCEM-UCS) Caxias Do Sul
Brazil Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner Curitiba
Brazil Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) Porto Alegre
Brazil INCA Instituto Nacional De Cancer Rio De Janeiro
Brazil Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto São José Do Rio Preto
Brazil Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda São Paulo
Czechia Multiscan s.r.o - Onkologická ambulance Horovice
Czechia Fakultni nemocnice Hradec Kralove Hradec Králové
Czechia Fakultni nemocnice v Motole Prague
France Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes Lyon
France Institut de Cancérologie de l'Ouest Saint-Herblain
France EDOG - Institut Claudius Regaud - PPDS Toulouse
Italy Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi Bologna
Italy Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele Catania
Italy Ospedale San Raffaele S.r.l. - PPDS Milano Lombardia
Italy ASST di Monza - Azienda Ospedaliera San Gerardo Monza Milano
Italy Azienda Ospedaliera Universitaria - Università degli studi della Campania "Luigi Vanvitelli" Napoli
Korea, Republic of National Cancer Center Goyang-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seul
Korea, Republic of Ulsan University Hospital Ulsan
Russian Federation LLC Evimed Chelyabinsk
Russian Federation Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy Krasnoyarsk
Russian Federation Medical Center Tonus Nizhny Novgorod
Russian Federation Budgetary Healthcare Institution of the Omsk region "Clinical Oncology Dispensary" Omsk
Russian Federation Evromedservis LCC Pushkin
Russian Federation Mordovia State University Saransk
Russian Federation Research Oncology Institute of Tomsk Scientific Center Tomsk
Russian Federation Volgograd Regional Clinical Oncology Dispensary Volgograd
Spain Hospital Universitario A Coruña A Coruña
Spain Hospital Universitario de Badajoz Badajoz
Spain Hospital Universitario Germans Trias i Pujol Badalona Barcelona
Spain Hospital Quironsalud Barcelona Barcelona Cataluña
Spain Hospital Universitario Vall D'Hebrón Barcelona
Spain ICO l'Hospitalet - Hospital Duran i Reynals L'Hospitalet De Llobregat Barcelona
Spain Hospital Universitari Arnau de Vilanova Lleida Cataluña
Spain Hospital Clinico San Carlos Madrid
Spain Hospital General Universitario Gregorio Marañon Madrid
Spain Hospital Ruber Internacional Madrid
Spain Hospital Universitario Virgen Macarena Sevilla Andalucia
Spain Hospital Clinico Universitario de Valencia Valencia
Taiwan Chi Mei Medical Center, Liouying Tainan City
Taiwan Koo Foundation Sun Yat-Sen Cancer Center Taipei
Taiwan Taipei Veterans General Hospital Taipei
Ukraine LLC Medical Center Family Medicine Clinic Dnipro
Ukraine Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS Dnipro
Ukraine Municipal Institution SubCarpathian Clinical Oncological Centre Ivano-Frankivs'k
Ukraine CNCE of Lviv Regional Council Lviv Oncological Regional Therapeutical and Diagnostic Centre Lviv
United Kingdom Leicester Royal Infirmary Leicester
United Kingdom Barts Cancer Institute London
United States University Cancer and Blood Center, LLC Athens Georgia
United States Piedmont Cancer Institute PC Atlanta Georgia
United States University of Vermont Medical Center Burlington Vermont
United States Florida Cancer Specialists SOUTH - SCRI - PPDS Fort Myers Florida
United States California Cancer Associates for Research and Excellence Fresno California
United States CHI Health St. Francis Grand Island Nebraska
United States HCA Midwest Health - SCRI - PPDS Kansas City Missouri
United States Saint Luke's Cancer Institute 150 Entrance Kansas City Missouri
United States Herbert-Herman Cancer Center, Sparrow Hospital Lansing Michigan
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Cedars-Sinai Medical Center Los Angeles California
United States Virginia Piper Cancer Institute Minneapolis Minnesota
United States West Virginia University Hospital Morgantown West Virginia
United States Sarah Cannon Research Institute Nashville Tennessee
United States Queens Hospital Cancer Center New York New York
United States Norwalk Hospital Norwalk Connecticut
United States Orlando Health Orlando Florida
United States Magee Women's Hospital Pittsburgh Pennsylvania
United States OHSU Knight Cancer Institute Hematology Oncology Portland Oregon
United States Mercy Research Oncology Saint Louis Missouri
United States Florida Cancer Specialists NORTH - SCRI - PPDS Saint Petersburg Florida
United States UCSF Mount Zion Cancer Center San Francisco California
United States Stanford Cancer Center South Bay San Jose California
United States Orchard Healthcare Research Inc Skokie Illinois
United States Florida Cancer Specialists PAN - SCRI - PPDS Tallahassee Florida
United States Tallahassee Memorial HealthCare Tallahassee Florida
United States Vanderbilt University Medical Center Tennessee Tennessee
United States Florida Cancer Specialists EAST - SCRI - PPDS West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Spexis AG

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Czechia,  France,  Italy,  Korea, Republic of,  Russian Federation,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (2nd Line+ Population) To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on the primary endpoint of progression free survival (PFS). PFS, as assessed by the Independent Review Committee, defined as the time from the date of randomization to the earliest evidence of documented progressive disease or death from any cause. Patients who were alive without postbaseline assessments or without documented progressive disease, lost to follow-up, withdrew consent, started an anticancer therapy prior to observing a progressive disease or with an event documented after 2 or more missing tumor assessments were censored.
PFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met.
Primary Progression Free Survival (3rd Line+ Population) To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on the primary endpoint of progression free survival (PFS). PFS, as assessed by the Independent Review Committee, defined as the time from the date of randomization to the earliest evidence of documented progressive disease or death from any cause. Patients who were alive without postbaseline assessments or without documented progressive disease, lost to follow-up, withdrew consent, started an anticancer therapy prior to observing a progressive disease or with an event documented after 2 or more missing tumor assessments were censored.
PFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met.
Secondary Overall Survival (3rd Line+ Population) To compare the overall survival (OS) between patients in the balixafortide + eribulin treatment arm versus eribulin monotherapy treatment arm. OS is defined as the time from date of randomization to date of death due to any cause. Patients who are lost to follow-up or are not known to have died at the time of data-cut-off for analysis or who do not have any follow up since randomization were censored. The Investigator monitored the patient for OS status every 6 months (or more frequently) until: death, the patient withdrew consent to follow-up for survival, or until the patient was lost to follow-up (whichever occurred first).
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