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

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ClinicalTrials.gov Identifier: NCT04529850
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Galera Therapeutics, Inc.

Brief Summary:
GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 when administered IV in combination with IMRT/cisplatin to up to 70 subjects with head and neck cancer, who are at high risk for SOM.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Oral Mucositis Drug: Drug: GC4419 Phase 2

Detailed Description:

Subjects will receive 90 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks, plus cisplatin administered 100 mg/m2 once every three weeks for 3 doses or 40 mg/m2 once weekly for 6-7 doses (Investigator's choice).

All subjects will be assessed twice weekly for OM per WHO grading criteria until 28 days post end of study treatment period (last day of IMRT).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: to evaluate the effects of GC4419 in subjects with head and neck cancer, who are at high risk for SOM
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open Label Multi-Center Study of the Effects of Superoxide Dismutase Mimetic GC4419 When Administered to Reduce the Incidence and Severity of Severe Oral Mucositis (SOM) Associated With Chemoradiotherapy for Locally Advanced, Non-Metastatic Head and Neck Cancer
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open Label Active Arm
90mg GC4419 by IV
Drug: Drug: GC4419
GC4419 60 Minute Infusion




Primary Outcome Measures :
  1. Incidence of treatment emergent AE's [ Time Frame: First treatment through 28 days post last dose of GC4419 ]

Secondary Outcome Measures :
  1. Cumulative Incidence of Severe OM [ Time Frame: First treatment through 28 days post last dose of GC4419 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically-confirmed diagnosis of locally advanced squamous cell carcinoma of the head and neck that will be treated with cisplatin plus concurrent IMRT.
  2. Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy.
  3. Patients who have had prior surgery may be eligible,
  4. Treatment plan to receive standard cisplatin monotherapy administered either every three weeks (100 mg/m2 for 3 doses) or weekly (40 mg/m2 for 6-7 doses).
  5. Age 18 years or older
  6. ECOG performance status ≤ 2
  7. Adequate hematologic function
  8. Adequate renal and liver function Alkaline phosphatase ≤ 2.5 ULN

Exclusion Criteria:

  1. Metastatic disease
  2. Prior radiotherapy to the region of the study cancer or adjacent anatomical sites
  3. Prior induction chemotherapy or plans for chemotherapy to be administered only sequentially with IMRT
  4. Planned concurrent chemotherapy other than single agent cisplatin
  5. Receiving any approved or investigational anti-cancer agent
  6. Concurrent participation in another interventional clinical study
  7. Inability to eat soft solid food at baseline for reasons other than mouth soreness after surgery or dental procedures
  8. Complete reliance on parenteral or gastrointestinal tube-delivered nutrition at baseline
  9. Malignant tumors other than head and neck cancer (HNC) within the last 5 years
  10. Active infectious disease excluding oral candidiasis
  11. Presence of oral mucositis at baseline.
  12. Known history of human immunodeficiency virus (HIV) or active hepatitis B/C
  13. Female patients who are pregnant or breastfeeding
  14. Known allergies or intolerance to cisplatin and similar platinum-containing compounds
  15. Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating Investigator, create a risk for a precipitous decrease in blood pressure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529850


Contacts
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Contact: Megan Holm 610-725-1500 info@galeratx.com
Contact: Jon Holmlund, MD 610-725-1500 info@galeratx.com

Locations
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Belgium
Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst Recruiting
Aalst, Belgium
Contact: Greet Huygh       greet.huygh@olvz-aalst.be   
Principal Investigator: Greet Huygh         
AZ Klina Recruiting
Brasschaat, Belgium
Contact: Wim Demey       wim.demey@klina.be   
Principal Investigator: Wim Demey         
Az Nikolaas Recruiting
Sint-Niklaas, Belgium
Contact: Willem Lybaert       willem.lybaert@aznikolaas.be   
Principal Investigator: Willem Lybaert         
Czechia
Fakultni Nemocnice Na Bulovce Recruiting
Praha, Czechia
Contact: Petra Holeckova       petra.holeckova@bulovka.cz   
Principal Investigator: Petra Holeckova         
Poland
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy Recruiting
Bydgoszcz, Poland
Contact: Bogdan Zurawski       zurawskib@co.bydgoszcz.pl   
Principal Investigator: Bogdan Zurawski         
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Recruiting
Kraków, Poland
Contact: Marta Urbanska-Gasiorowska       m.urbanska-gasiorowska@amethyst-rtcp.pl   
Principal Investigator: Marta Urbanska-Gasiorowska         
Spain
Gurutzetako Unibersitate Ospitalea - Hospital Universitario Cruces - Instituto BioCruces Recruiting
Barakaldo, Spain
Contact: Jon Cacicedo Fernandez de Bobadilla       jon.cacicedofernandezbobadilla@osakidetza.eus   
Principal Investigator: Jon Cacicedo Fernandez de Bobadilla         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Jordi Giralt       jgiralt@vhebron.net   
Principal Investigator: Jordi Giralt         
Hospital Universitario de Fuenlabrada Recruiting
Fuenlabrada, Spain
Contact: David Gutierrez Abad       dgutierreza@salud.madrid.org   
Principal Investigator: David Gutierrez Abad         
Institut Catala d'Oncologia de Girona Recruiting
Girona, Spain
Contact: jordi Marruecos Querol       jmarruecos@iconcologia.net   
Principal Investigator: jordi Marruecos Querol         
Hospital Madrid Universitario Sanchinarro (Centro Integral Oncologico Clara Campal) Recruiting
Madrid, Spain
Contact: Lisardo Ugidos       lugidos@hmhospitales.com   
Principal Investigator: Lisardo Ugidos         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain
Contact: Asuncion Hervas Moron       ahervas.hrc@salud.madrid.org   
Principal Investigator: Asuncion Hervas Moron         
Complejo Hospitalario de Navarra (CHN) Recruiting
Pamplona, Spain
Contact: Fernando Arias De La Vega       fernando.arias.delavega@navarra.es   
Principal Investigator: Fernando Arias De La Vega         
Hospital universitario Virgen del Rocio Recruiting
Salamanca, Spain
Contact: Jeronimo Pachon Ibanez       jpachoni@telefonica.net   
Principal Investigator: Jeronimo Pachon Ibanez         
Universidad de Salamanca - Hospital Clinico Universitario Recruiting
Salamanca, Spain
Contact: Luis Perez Romasanta       lapromasanta@saludcastillayleon.es   
Principal Investigator: Luis Perez Romasanta         
Switzerland
University Hospital Basel Recruiting
Basel, Switzerland
Contact: Andrei Bunea       andrei.bunea@usb.ch   
Principal Investigator: Andrei Bunea         
Sponsors and Collaborators
Galera Therapeutics, Inc.
Investigators
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Study Chair: Jon Holmlund, MD Chief Medical Officer
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Responsible Party: Galera Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04529850    
Other Study ID Numbers: GTI-4419-202
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases