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

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

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)

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Oral Mucositis
• Intervention / Treatment: Drug: Drug: GC4419; Radiation: Intensity-modulated radiation therapy (IMRT); Drug: Cisplatin

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst
  • Brasschaat, Belgium
    • AZ Klina
  • Sint-Niklaas, Belgium
    • AZ Nikolaas
  • Verviers, Belgium
    • CHR Verviers
• Czechia
  • Praha, Czechia
    • Fakultni nemocnice Na Bulovce
• Germany
  • Kiel, Germany
    • University Medical Center Schleswig-Holstein
  • Leipzig, Germany
    • Universitatsklinikum Leipzig AOR
• Poland
  • Bydgoszcz, Poland
    • Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
  • Kraków, Poland
    • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
  • Pomorskie, Poland
    • Szpitale Pomorskie Sp. z o.o.
  • Warsaw, Poland
    • Cancer Center Institute of Oncology
• Spain
  • A Coruña, Spain
    • Complejo Hospitalario Universitario De Santiago De Compostela
  • Barakaldo, Spain
    • Gurutzetako Unibersitate Ospitalea - Hospital Universitario Cruces - Instituto BioCruces
  • Barcelona, Spain
    • Hospital Universitari Vall d'Hebron
  • Fuenlabrada, Spain
    • Hospital Universitario de Fuenlabrada
  • Girona, Spain
    • Institut Catala d'Oncologia de Girona
  • Jaén, Spain
    • Complejo Hospitalario de Jaén
  • Madrid, Spain
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain
    • Hospital Madrid Universitario Sanchinarro (Centro Integral Oncologico Clara Campal)
  • Pamplona, Spain
    • Complejo Hospitalario de Navarra (CHN)
  • Salamanca, Spain
    • Hospital Universitario Virgen del Rocio
  • Salamanca, Spain
    • Universidad de Salamanca - Hospital Clinico Universitario
• Switzerland
  • Basel, Switzerland
    • University Hospital Basel
  • Freiburg, Switzerland
    • University Hospital of Bern, Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Emergent AE's	Number of Subjects with at Least One Treatment Emergent Adverse Event (TEAE)	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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Galera Therapeutics, Inc.
• Investigators: Study Chair: Jon Holmlund, MD, Chief Medical Officer

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2020
• Primary Completion (ACTUAL): March 10, 2021
• Study Completion (ACTUAL): March 10, 2021

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (ACTUAL): August 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Head and Neck Neoplasms; Mucositis; Stomatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protective Agents; Antioxidants; Cisplatin; Avasopasem manganese
• Other Study ID Numbers: GTI-4419-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No