Trials Sponsors Conditions Drugs Pricing

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: GC4419Radiation: Intensity-modulated radiation therapy (IMRT)Drug: Cisplatin

Interventions

Drug: GC4419Drug

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Galera Therapeutics, Inc.
Industrylead

Study Sites (24)

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

MeSH Terms

Conditions

Head and Neck NeoplasmsStomatitis

Interventions

avasopasem manganeseRadiotherapy, Intensity-ModulatedCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Results Point of Contact

Title: Judy Schnyder
Organization: Galera Therapeutics

Study Officials

Jon Holmlund, MD
Chief Medical Officer
STUDY CHAIR

Publication Agreements

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

Enrollment

38 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 28, 2020

Study Start

June 30, 2020

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Open Label Active Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (24)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Open Label Active Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (24)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations