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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04529850
• Other study ID #: GTI-4419-202
• Status: Completed
• Phase: Phase 2
• Start date: June 30, 2020
• Est. completion date: March 10, 2021

Study information

• Verified date: January 2022
• Source: Galera Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 10, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Galera Therapeutics, Inc.

Countries where clinical trial is conducted

Belgium,  Czechia,  Germany,  Poland,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.