Back to resultsPh 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer
Primary Purpose
Head and Neck Cancer, Oral Mucositis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Drug: GC4419
Intensity-modulated radiation therapy (IMRT)
Cisplatin
Sponsored by
About this trial
This is an interventional prevention trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- Pathologically-confirmed diagnosis of locally advanced squamous cell carcinoma of the head and neck that will be treated with cisplatin plus concurrent IMRT.
- 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.
- Patients who have had prior surgery may be eligible,
- 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).
- Age 18 years or older
- ECOG performance status ≤ 2
- Adequate hematologic function
- Adequate renal and liver function Alkaline phosphatase ≤ 2.5 ULN
Exclusion Criteria:
- Metastatic disease
- Prior radiotherapy to the region of the study cancer or adjacent anatomical sites
- Prior induction chemotherapy or plans for chemotherapy to be administered only sequentially with IMRT
- Planned concurrent chemotherapy other than single agent cisplatin
- Receiving any approved or investigational anti-cancer agent
- Concurrent participation in another interventional clinical study
- Inability to eat soft solid food at baseline for reasons other than mouth soreness after surgery or dental procedures
- Complete reliance on parenteral or gastrointestinal tube-delivered nutrition at baseline
- Malignant tumors other than head and neck cancer (HNC) within the last 5 years
- Active infectious disease excluding oral candidiasis
- Presence of oral mucositis at baseline.
- Known history of human immunodeficiency virus (HIV) or active hepatitis B/C
- Female patients who are pregnant or breastfeeding
- Known allergies or intolerance to cisplatin and similar platinum-containing compounds
- 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.
Sites / Locations
- Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst
- AZ Klina
- Az Nikolaas
- CHR Verviers
- Fakultni Nemocnice Na Bulovce
- University Medical Center Schleswig-Holstein
- Universitatsklinikum Leipzig AoR
- Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
- Szpitale Pomorskie Sp. z o.o.
- Cancer Center Institute of Oncology
- Complejo Hospitalario Universitario De Santiago De Compostela
- Gurutzetako Unibersitate Ospitalea - Hospital Universitario Cruces - Instituto BioCruces
- Hospital Universitari Vall d'Hebron
- Hospital Universitario de Fuenlabrada
- Institut Catala d'Oncologia de Girona
- Complejo Hospitalario de Jaen
- Hospital Madrid Universitario Sanchinarro (Centro Integral Oncologico Clara Campal)
- Hospital Universitario Ramon y Cajal
- Complejo Hospitalario de Navarra (CHN)
- Hospital universitario Virgen del Rocio
- Universidad de Salamanca - Hospital Clinico Universitario
- University Hospital Basel
- University Hospital of Bern, Inselspital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open Label Active Arm
Arm Description
90mg GC4419 by IV
Outcomes
Primary Outcome Measures
Incidence of Treatment Emergent AE's
Number of Subjects with at Least One Treatment Emergent Adverse Event (TEAE)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT04529850
First Posted
August 13, 2020
Last Updated
July 21, 2022
Sponsor
Galera Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04529850
Brief Title
Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
March 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galera Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Oral Mucositis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Label Active Arm
Arm Type
Experimental
Arm Description
90mg GC4419 by IV
Intervention Type
Drug
Intervention Name(s)
Drug: GC4419
Intervention Description
GC4419 60 Minute Infusion
Intervention Type
Radiation
Intervention Name(s)
Intensity-modulated radiation therapy (IMRT)
Intervention Description
2.0 to 2.2 Gy daily over 7 weeks
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
100mg/m2 once every 3 weeks or 40mg/m2 once weekly for 6-7 doses
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent AE's
Description
Number of Subjects with at Least One Treatment Emergent Adverse Event (TEAE)
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
Secondary Outcome Measure Information:
Title
Cumulative Incidence of Severe OM
Description
Cumulative Incidence of WHO Grade 3-4 from the start of IMRT through the end of the study treatment period (last day of IMRT)
Time Frame
From start of Intensity-modulated radiation therapy (IMRT) through approximately 30 fractions which is estimated to be 6-7 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathologically-confirmed diagnosis of locally advanced squamous cell carcinoma of the head and neck that will be treated with cisplatin plus concurrent IMRT.
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.
Patients who have had prior surgery may be eligible,
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).
Age 18 years or older
ECOG performance status ≤ 2
Adequate hematologic function
Adequate renal and liver function Alkaline phosphatase ≤ 2.5 ULN
Exclusion Criteria:
Metastatic disease
Prior radiotherapy to the region of the study cancer or adjacent anatomical sites
Prior induction chemotherapy or plans for chemotherapy to be administered only sequentially with IMRT
Planned concurrent chemotherapy other than single agent cisplatin
Receiving any approved or investigational anti-cancer agent
Concurrent participation in another interventional clinical study
Inability to eat soft solid food at baseline for reasons other than mouth soreness after surgery or dental procedures
Complete reliance on parenteral or gastrointestinal tube-delivered nutrition at baseline
Malignant tumors other than head and neck cancer (HNC) within the last 5 years
Active infectious disease excluding oral candidiasis
Presence of oral mucositis at baseline.
Known history of human immunodeficiency virus (HIV) or active hepatitis B/C
Female patients who are pregnant or breastfeeding
Known allergies or intolerance to cisplatin and similar platinum-containing compounds
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Holmlund, MD
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Chair
Facility Information:
Facility Name
Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst
City
Aalst
Country
Belgium
Facility Name
AZ Klina
City
Brasschaat
Country
Belgium
Facility Name
Az Nikolaas
City
Sint-Niklaas
Country
Belgium
Facility Name
CHR Verviers
City
Verviers
Country
Belgium
Facility Name
Fakultni Nemocnice Na Bulovce
City
Praha
Country
Czechia
Facility Name
University Medical Center Schleswig-Holstein
City
Kiel
Country
Germany
Facility Name
Universitatsklinikum Leipzig AoR
City
Leipzig
Country
Germany
Facility Name
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
City
Bydgoszcz
Country
Poland
Facility Name
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
City
Kraków
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o.o.
City
Pomorskie
Country
Poland
Facility Name
Cancer Center Institute of Oncology
City
Warsaw
Country
Poland
Facility Name
Complejo Hospitalario Universitario De Santiago De Compostela
City
A Coruña
Country
Spain
Facility Name
Gurutzetako Unibersitate Ospitalea - Hospital Universitario Cruces - Instituto BioCruces
City
Barakaldo
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
Country
Spain
Facility Name
Institut Catala d'Oncologia de Girona
City
Girona
Country
Spain
Facility Name
Complejo Hospitalario de Jaen
City
Jaén
Country
Spain
Facility Name
Hospital Madrid Universitario Sanchinarro (Centro Integral Oncologico Clara Campal)
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
Country
Spain
Facility Name
Complejo Hospitalario de Navarra (CHN)
City
Pamplona
Country
Spain
Facility Name
Hospital universitario Virgen del Rocio
City
Salamanca
Country
Spain
Facility Name
Universidad de Salamanca - Hospital Clinico Universitario
City
Salamanca
Country
Spain
Facility Name
University Hospital Basel
City
Basel
Country
Switzerland
Facility Name
University Hospital of Bern, Inselspital
City
Freiburg
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer
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