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

Phase 2

Completed

• Conditions: Head and Neck Cancer; Oral Mucositis
• Interventions: Radiation: Intensity-modulated radiation therapy (IMRT); Drug: Cisplatin

• Registration Number: NCT04529850
• Lead Sponsor: Galera Therapeutics, Inc.

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).

Study Timeline

• Study Start: 2020-06-30
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-28
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Status Verified: 2022-01
• Results First Submitted: 2022-06-02
• Results First Submitted QC: 2022-07-21
• Last Update Submitted: 2022-07-21
• Results First Posted: 2022-08-16
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Active Arm	Intensity-modulated radiation therapy (IMRT)	90mg GC4419 by IV
Open Label Active Arm	Cisplatin	90mg GC4419 by IV

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent AE's	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

Name	Time	Method
Cumulative Incidence of Severe OM	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)

Trial Locations

Locations (24)

Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy; 🇵🇱 Bydgoszcz, Poland

Universitatsklinikum Leipzig AoR; 🇩🇪 Leipzig, Germany

Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst; 🇧🇪 Aalst, Belgium

Cancer Center Institute of Oncology; 🇵🇱 Warsaw, Poland

University Hospital Basel; 🇨🇭 Basel, Switzerland

Complejo Hospitalario Universitario De Santiago De Compostela; 🇪🇸 A Coruña, Spain

Hospital Madrid Universitario Sanchinarro (Centro Integral Oncologico Clara Campal); 🇪🇸 Madrid, Spain

Gurutzetako Unibersitate Ospitalea - Hospital Universitario Cruces - Instituto BioCruces; 🇪🇸 Barakaldo, Spain

AZ Klina; 🇧🇪 Brasschaat, Belgium

Az Nikolaas; 🇧🇪 Sint-Niklaas, Belgium

CHR Verviers; 🇧🇪 Verviers, Belgium

Fakultni Nemocnice Na Bulovce; 🇨🇿 Praha, Czechia

University Medical Center Schleswig-Holstein; 🇩🇪 Kiel, Germany

Complejo Hospitalario de Jaen; 🇪🇸 Jaén, Spain

Szpitale Pomorskie Sp. z o.o.; 🇵🇱 Pomorskie, Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie; 🇵🇱 Kraków, Poland

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Institut Catala d'Oncologia de Girona; 🇪🇸 Girona, Spain

Hospital Universitario de Fuenlabrada; 🇪🇸 Fuenlabrada, Spain

Hospital Universitario Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital universitario Virgen del Rocio; 🇪🇸 Salamanca, Spain

Complejo Hospitalario de Navarra (CHN); 🇪🇸 Pamplona, Spain

Universidad de Salamanca - Hospital Clinico Universitario; 🇪🇸 Salamanca, Spain

University Hospital of Bern, Inselspital; 🇨🇭 Freiburg, Switzerland