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

NCT04529850 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GTI-4419-202
• Study Type: interventional
• Target: 38
• Locations: 6 countries
• Sites: 24

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)

Conditions

Head and Neck Cancer; Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

Open Label Active Arm

EXPERIMENTAL

90mg GC4419 by IV

Drug: Drug: GC4419; Radiation: Intensity-modulated radiation therapy (IMRT); Drug: Cisplatin

Interventions

Drug: GC4419 DRUG

GC4419 60 Minute Infusion

Open Label Active Arm

Intensity-modulated radiation therapy (IMRT) RADIATION

2.0 to 2.2 Gy daily over 7 weeks

Open Label Active Arm

Cisplatin DRUG

100mg/m2 once every 3 weeks or 40mg/m2 once weekly for 6-7 doses

Open Label Active Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galera Therapeutics, Inc.: lead

Study Sites (24)

Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst

Aalst, Belgium

Location

AZ Klina

Brasschaat, Belgium

Location

Az Nikolaas

Sint-Niklaas, Belgium

Location

CHR Verviers

Verviers, Belgium

Location

Fakultni Nemocnice Na Bulovce

Prague, Czechia

Location

University Medical Center Schleswig-Holstein

Kiel, Germany

Location

Universitatsklinikum Leipzig AoR

Leipzig, Germany

Location

Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

Bydgoszcz, Poland

Location

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

Krakow, Poland

Location

Szpitale Pomorskie Sp. z o.o.

Pomorskie, Poland

Location

Cancer Center Institute of Oncology

Warsaw, Poland

Location

Complejo Hospitalario Universitario De Santiago De Compostela

A Coruña, Spain

Location

Gurutzetako Unibersitate Ospitalea - Hospital Universitario Cruces - Instituto BioCruces

Barakaldo, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Spain

Location

Institut Catala d'Oncologia de Girona

Girona, Spain

Location

Complejo Hospitalario de Jaen

Jaén, Spain

Location

Hospital Madrid Universitario Sanchinarro (Centro Integral Oncologico Clara Campal)

Madrid, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, Spain

Location

Complejo Hospitalario de Navarra (CHN)

Pamplona, Spain

Location

Hospital universitario Virgen del Rocio

Salamanca, Spain

Location

Universidad de Salamanca - Hospital Clinico Universitario

Salamanca, Spain

Location

University Hospital Basel

Basel, Switzerland

Location

University Hospital of Bern, Inselspital

Fribourg, Switzerland

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis

Interventions

avasopasem manganese; Radiotherapy, Intensity-Modulated; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Judy Schnyder
• Organization: Galera Therapeutics

jschnyder@galeratx.com

484-870-9625

Study Officials

• Jon Holmlund, MD

  Chief Medical Officer

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: To evaluate the effects of GC4419 in subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 28, 2020
• Study Start: June 30, 2020
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: August 16, 2022
• Results First Posted: August 16, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4); CZ (1); DE (2); PL (4); CH (2); ES (11)