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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04529850
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : August 28, 2020
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT04529850

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Contact: Megan Holm 610-725-1500
Contact: Jon Holmlund, MD 610-725-1500

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Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst Recruiting
Aalst, Belgium
Contact: Greet Huygh   
Principal Investigator: Greet Huygh         
AZ Klina Recruiting
Brasschaat, Belgium
Contact: Wim Demey   
Principal Investigator: Wim Demey         
Az Nikolaas Recruiting
Sint-Niklaas, Belgium
Contact: Willem Lybaert   
Principal Investigator: Willem Lybaert         
Fakultni Nemocnice Na Bulovce Recruiting
Praha, Czechia
Contact: Petra Holeckova   
Principal Investigator: Petra Holeckova         
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy Recruiting
Bydgoszcz, Poland
Contact: Bogdan Zurawski   
Principal Investigator: Bogdan Zurawski         
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Recruiting
Kraków, Poland
Contact: Marta Urbanska-Gasiorowska   
Principal Investigator: Marta Urbanska-Gasiorowska         
Gurutzetako Unibersitate Ospitalea - Hospital Universitario Cruces - Instituto BioCruces Recruiting
Barakaldo, Spain
Contact: Jon Cacicedo Fernandez de Bobadilla   
Principal Investigator: Jon Cacicedo Fernandez de Bobadilla         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Jordi Giralt   
Principal Investigator: Jordi Giralt         
Hospital Universitario de Fuenlabrada Recruiting
Fuenlabrada, Spain
Contact: David Gutierrez Abad   
Principal Investigator: David Gutierrez Abad         
Institut Catala d'Oncologia de Girona Recruiting
Girona, Spain
Contact: jordi Marruecos Querol   
Principal Investigator: jordi Marruecos Querol         
Hospital Madrid Universitario Sanchinarro (Centro Integral Oncologico Clara Campal) Recruiting
Madrid, Spain
Contact: Lisardo Ugidos   
Principal Investigator: Lisardo Ugidos         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain
Contact: Asuncion Hervas Moron   
Principal Investigator: Asuncion Hervas Moron         
Complejo Hospitalario de Navarra (CHN) Recruiting
Pamplona, Spain
Contact: Fernando Arias De La Vega   
Principal Investigator: Fernando Arias De La Vega         
Hospital universitario Virgen del Rocio Recruiting
Salamanca, Spain
Contact: Jeronimo Pachon Ibanez   
Principal Investigator: Jeronimo Pachon Ibanez         
Universidad de Salamanca - Hospital Clinico Universitario Recruiting
Salamanca, Spain
Contact: Luis Perez Romasanta   
Principal Investigator: Luis Perez Romasanta         
University Hospital Basel Recruiting
Basel, Switzerland
Contact: Andrei Bunea   
Principal Investigator: Andrei Bunea         
Sponsors and Collaborators
Galera Therapeutics, Inc.
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Study Chair: Jon Holmlund, MD Chief Medical Officer
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Responsible Party: Galera Therapeutics, Inc. 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
Neoplasms by Site
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases