Clinical trial NCT04529850: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Oral Mucositis
Lead sponsor: Galera Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-28
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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)
Primary purpose: PREVENTION

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).

Eligibility 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.

Primary outcomes:
measure: Incidence of Treatment Emergent AE's
timeFrame: 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 outcomes:
measure: Cumulative Incidence of Severe OM
timeFrame: From start of Intensity-modulated radiation therapy (IMRT) through approximately 30 fractions which is estimated to be 6-7 weeks.
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Sint-Niklaas
country: Belgium
facility: Az Nikolaas
city: Verviers
country: Belgium
facility: CHR Verviers
city: Praha
country: Czechia
facility: Fakultni Nemocnice Na Bulovce
city: Kiel
country: Germany
facility: University Medical Center Schleswig-Holstein
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig AoR
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
city: Kraków
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
city: Pomorskie
country: Poland
facility: Szpitale Pomorskie Sp. z o.o.
city: Warsaw
country: Poland
facility: Cancer Center Institute of Oncology
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario De Santiago De Compostela
city: Barakaldo
country: Spain
facility: Gurutzetako Unibersitate Ospitalea - Hospital Universitario Cruces - Instituto BioCruces
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Girona
country: Spain
facility: Institut Catala d'Oncologia de Girona
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaen
city: Madrid
country: Spain
facility: Hospital Madrid Universitario Sanchinarro (Centro Integral Oncologico Clara Campal)
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra (CHN)
city: Salamanca
country: Spain
facility: Hospital universitario Virgen del Rocio
city: Salamanca
country: Spain
facility: Universidad de Salamanca - Hospital Clinico Universitario
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Freiburg
country: Switzerland
facility: University Hospital of Bern, Inselspital
Study officials:
affiliation: Chief Medical Officer
name: Jon Holmlund, MD
role: STUDY_CHAIR
References: