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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04529850
Recruitment Status : Completed
First Posted : August 28, 2020
Results First Posted : August 16, 2022
Last Update Posted : August 16, 2022
Sponsor:
Information provided by (Responsible Party):
Galera Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Oral Mucositis Drug: Drug: GC4419 Radiation: Intensity-modulated radiation therapy (IMRT) Drug: Cisplatin 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 Oral Mucositis (OM) per WHO grading criteria until 28 days post end of study treatment period (last day of IMRT).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 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 Severe Oral Mucositis (SOM)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open Label Multi-Center Study of the Effects of GC4419 When Administered to Reduce the Incidence and Severity of Severe Oral Mucositis Associated With Chemo RT for Locally Advanced, Non-Metastatic Head and Neck Cancer
Actual Study Start Date : June 30, 2020
Actual Primary Completion Date : March 10, 2021
Actual Study Completion Date : March 10, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Label Active Arm
90mg GC4419 by IV
 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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment Emergent AE's [ Time Frame: First dose of study medication through the 30 days following the last dose of IMRT, GC4419, or cisplatin (whichever occurs last) which is estimated to be 11 weeks ]
    Number of Subjects with at Least One Treatment Emergent Adverse Event (TEAE)


Secondary Outcome Measures :
  1. Cumulative Incidence of Severe OM [ Time Frame: From start of Intensity-modulated radiation therapy (IMRT) through approximately 30 fractions which is estimated to be 6-7 weeks. ]
    Cumulative Incidence of WHO Grade 3-4 from the start of IMRT through the end of the study treatment period (last day of IMRT)


Eligibility Criteria
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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.
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Galera Therapeutics, Inc.
Investigators
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Study Chair: Jon Holmlund, MD Chief Medical Officer
  Study Documents (Full-Text)

Documents provided by Galera Therapeutics, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] September 2, 2020

More Information
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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
Results First Posted: August 16, 2022
Last Update Posted: August 16, 2022
Last Verified: January 2022
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
Avasopasem manganese
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs