Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

June 30, 2020

Primary Completion Date

March 10, 2021

Study Completion Date

March 10, 2021

Conditions
Head and Neck CancerOral Mucositis
Interventions
DRUG

Drug: GC4419

GC4419 60 Minute Infusion

RADIATION

Intensity-modulated radiation therapy (IMRT)

2.0 to 2.2 Gy daily over 7 weeks

DRUG

Cisplatin

100mg/m2 once every 3 weeks or 40mg/m2 once weekly for 6-7 doses

Trial Locations (24)

Unknown

Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst, Aalst

AZ Klina, Brasschaat

Az Nikolaas, Sint-Niklaas

CHR Verviers, Verviers

Fakultni Nemocnice Na Bulovce, Prague

University Medical Center Schleswig-Holstein, Kiel

Universitatsklinikum Leipzig AoR, Leipzig

Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy, Bydgoszcz

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Krakow

Szpitale Pomorskie Sp. z o.o., Pomorskie

Cancer Center Institute of Oncology, Warsaw

Complejo Hospitalario Universitario De Santiago De Compostela, A Coruña

Gurutzetako Unibersitate Ospitalea - Hospital Universitario Cruces - Instituto BioCruces, Barakaldo

Hospital Universitari Vall d'Hebron, Barcelona

Hospital Universitario de Fuenlabrada, Fuenlabrada

Institut Catala d'Oncologia de Girona, Girona

Complejo Hospitalario de Jaen, Jaén

Hospital Madrid Universitario Sanchinarro (Centro Integral Oncologico Clara Campal), Madrid

Hospital Universitario Ramon y Cajal, Madrid

Complejo Hospitalario de Navarra (CHN), Pamplona

Hospital universitario Virgen del Rocio, Salamanca

Universidad de Salamanca - Hospital Clinico Universitario, Salamanca

University Hospital Basel, Basel

University Hospital of Bern, Inselspital, Fribourg

Sponsors
All Listed Sponsors
lead

Galera Therapeutics, Inc.

INDUSTRY

NCT04529850 - Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer | Biotech Hunter | Biotech Hunter