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

NCT ID: NCT04529850

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2021-03-10

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).

Conditions

Head and Neck Cancer; Oral Mucositis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Open Label Active Arm

90mg GC4419 by IV

Group Type: EXPERIMENTAL

Drug: GC4419

Intervention Type: DRUG

GC4419 60 Minute Infusion

Intensity-modulated radiation therapy (IMRT)

Intervention Type: RADIATION

2.0 to 2.2 Gy daily over 7 weeks

Cisplatin

Intervention Type: DRUG

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

Interventions

Drug: GC4419

GC4419 60 Minute Infusion

Intervention Type: DRUG

Intensity-modulated radiation therapy (IMRT)

2.0 to 2.2 Gy daily over 7 weeks

Intervention Type: RADIATION

Cisplatin

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galera Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon Holmlund, MD

Role: STUDY_CHAIR

Chief Medical Officer

Locations

Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst

Aalst, , Belgium

AZ Klina

Brasschaat, , Belgium

Az Nikolaas

Sint-Niklaas, , Belgium

CHR Verviers

Verviers, , Belgium

Fakultni Nemocnice Na Bulovce

Prague, , Czechia

University Medical Center Schleswig-Holstein

Kiel, , Germany

Universitatsklinikum Leipzig AoR

Leipzig, , Germany

Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

Bydgoszcz, , Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

Krakow, , Poland

Szpitale Pomorskie Sp. z o.o.

Pomorskie, , Poland

Cancer Center Institute of Oncology

Warsaw, , Poland

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, , Spain

University Hospital Basel

Basel, , Switzerland

University Hospital of Bern, Inselspital

Fribourg, , Switzerland

Countries

Belgium; Czechia; Germany; Poland; Spain; Switzerland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GTI-4419-202

Identifier Type: -

Identifier Source: org_study_id