EsophagitisPhase 2NCT04225026

Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer

A Phase 2 study testing GC4419 (avasopasem manganese) in people with Esophagitis, run by Galera Therapeutics, Inc. at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

GTI-4419-203 will be an open-label, multi-center study to evaluate GC4419 (avasopasem manganese) administered intravenous (IV) for the reduction of radiation induced esophagitis in subjects receiving chemoradiotherapy for unresectable Stage 3A/3B or post-operative Stage 2B Non-Small Cell Lung Cancer (NSCLC) or Small… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Esophagitis
What is being tested?: GC4419 (avasopasem manganese)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 12 sitesUnited States
Study dates: 19 Dec 2019to 27 Mar 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects scheduled to be treated with (definitive or adjuvant) radiation therapy in combination with chemotherapy once daily for Stage 3A/3B or post-operative Stage 2B NSCLC or limited stage SCLC
Treatment plan for subjects show that 5 cm of the esophagus for at least one surface, is included in the 60 Gy isodose volume. Dose volume histograms show esophagus dose exposure meet V38>30% and/or V60>20%
Age 18 years or older
ECOG performance status ≤ 2
Adequate hematologic, renal and liver function
Use of highly effective contraception

Who cannot join

Metastatic disease
Prior radiation therapy to the region of the study cancer
Subjects not receiving chemotherapy
Grade 2 or greater esophagitis at baseline
Inability to provide information in the electronic symptom-reporting device
Receiving any approved or investigational immunotherapy, targeted therapy, hormone therapy, or biologic therapy

Show all 15Show fewer

Participation in another clinical trial or use of another investigational agent within 30 days of first does of GC4419
Malignant tumors other than the current lung cancer within the last 5 years
Previous diagnosis of pneumonitis
Untreated, active infectious disease requiring systemic anti-infective therapy
Untreated HIV or active hepatitis B/C
Females who are pregnant or breastfeeding
Known allergies or intolerance to chemotherapy and similar platinum-containing compounds
Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure
Clinically significant heart disease

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
IACT Health
Columbus, Georgia, 31904
Providence Regional Cancer Partnership
Everett, Washington, 98201
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
St. Francis Hospital
Greenville, South Carolina, 29601
University of Iowa
Iowa City, Iowa, 52242
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
University of Louisville
Louisville, Kentucky, 40202
Hackensack Meridian Health
Montclair, New Jersey, 07753
Cancer Care St. Joseph/Mosaic Life Care
Saint Joseph, Missouri, 64507
Spartanburg Regional Medical Center - Gibbs Cancer Center
Spartanburg, South Carolina, 29303
Tampa General Hospital
Tampa, Florida, 33606

Other trials in United States

About this study

Official title: A Phase 2a Open-Label Trial of the Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis in Subjects Receiving Chemoradiotherapy for Lung Cancer

Conditions: Esophagitis
Being tested: GC4419 (avasopasem manganese)
Medical subject headings: Esophagitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GC4419 (avasopasem manganese)Drug
Also called Avasopasem manganese
90 mg, by 60-minute IV infusion, prior to each fraction of RT

Study groups in NCT04225026
Study group	Role	What they receive
GC4419 (avasopasem manganese)	Experimental	Not described Receives: Drug: GC4419 (avasopasem manganese)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through the End of Chemoradiotherapy for Non-Small Cell Lung (NSCLC) or Small Cell Lung Cancer (SCLC) When Avasopasem Was Added.
Those subjects in the primary efficacy population that experience acute radiation esophagitis (Grade >/=2; NCI CTCAE version 5) through the end of chemoradiotherapy for NSCLC or SCLC when treated with avasopasem.
NCI CTCAE Grading:
Grade 1: asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2: symptomatic; altered eating/swallowing; oral supplements indicated Grade 3: severely altered eating/swallowing; tube feeding, total parental nutrition (TPN) or hospitalization Grade 4: life-threatening consequences; urgent operative intervention indicated Grade 5: death
Measured: From the first radiation therapy fraction through the end of the study treatment period, which is estimated to be 6 weeks.

Secondary outcomes (2)

Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through 4 Weeks After Completion of Chemoradiotherapy
Those subjects in the in the primary efficacy population that experience Grade >/= 2 (NCI CTCAE version 5) acute radiation esophagitis through 4 weeks after completion of chemoradiotherapy for NSCLC or SCLC when treated with avasopasem.
NCI CTCAE Grading:
Grade 1: asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2: symptomatic; altered eating/swallowing; oral supplements indicated Grade 3: severely altered eating/swallowing; tube feeding, total parental nutrition (TPN) or hospitalization Grade 4: life-threatening consequences; urgent operative intervention indicated Grade 5: death
Measured: From the first radiation therapy fraction through 4 weeks after the completion of chemoradiotherapy, which is estimated to be 10 weeks
Number of Subjects With Acute Severe Radiation Esophagitis (Defined as Grade 3-4; NCI CTCAE Version 5) Through Completion of Chemoradiotherapy.
Those subjects in the per protocol population that experienced Grade 3-4 acute radiation esophagitis through the completion of chemoradiotherapy.
NCI CTCAE Grading:
Grade 1: asymptomatic; clinical or diagnostic observations only; intervention not indicated; Grade 2: symptomatic; altered eating/swallowing; oral supplements indicated; Grade 3: severely altered eating/swallowing; tube feeding, total parental nutrition (TPN) or hospitalization; Grade 4: life-threatening consequences; urgent operative intervention indicated; Grade 5: Death.
Measured: From the first radiation therapy fraction through the completion of chemoradiotherapy, which is estimated to be 6 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Dec 201927 Mar 2022

First posted13 Jan 2020
Study start19 Dec 2019
Primary completion28 Dec 2021
Study completion27 Mar 2022

Why it stopped: Lack of study enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EsophagitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04225026
Sponsor's protocol ID: GTI-4419-203
Status last verified: Jun 2022
First submitted: 8 Jan 2020
Last updated: 23 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Not yet recruitingPhase 3
Risk-Adapted Segmental Esophagus-Sparing Radiotherapy for Definitive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach

All Esophagitis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a Open-Label Trial of the Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis in Subjects Receiving Chemoradiotherapy for Lung Cancer
ClinicalTrials.gov ID: NCT04225026
Acronym / sponsor ID: GTI-4419-203
Conditions: Esophagitis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of study enrollment
Enrolment: 39 participants (actual)
Lead sponsor: Galera Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 19 Dec 2019 (actual)
Primary completion: 28 Dec 2021 (actual)
Study completion: 27 Mar 2022 (actual)
First posted: 13 Jan 2020 (actual)
Results: Posted 23 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GC4419 (avasopasem manganese)	Experimental	Drug: GC4419 (avasopasem manganese)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subjects scheduled to be treated with (definitive or adjuvant) radiation therapy in combination with chemotherapy once daily for Stage 3A/3B or post-operative Stage 2B NSCLC or limited stage SCLC
Treatment plan for subjects show that 5 cm of the esophagus for at least one surface, is included in the 60 Gy isodose volume. Dose volume histograms show esophagus dose exposure meet V38>30% and/or V60>20%
Age 18 years or older
ECOG performance status ≤ 2
Adequate hematologic, renal and liver function

Key exclusion criteria (15 listed)

Metastatic disease
Prior radiation therapy to the region of the study cancer
Subjects not receiving chemotherapy
Grade 2 or greater esophagitis at baseline
Inability to provide information in the electronic symptom-reporting device

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GC4419 (avasopasem manganese)Also: Avasopasem manganese90 mg, by 60-minute IV infusion, prior to each fraction of RT	Drug	GC4419 (avasopasem manganese)

Primary outcome

Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through the End of Chemoradiotherapy for Non-Small Cell Lung (NSCLC) or Small Cell Lung Cancer (SCLC) When Avasopasem Was Added.
Time frame: From the first radiation therapy fraction through the end of the study treatment period, which is estimated to be 6 weeks.
Those subjects in the primary efficacy population that experience acute radiation esophagitis (Grade >/=2; NCI CTCAE version 5) through the end of chemoradiotherapy for NSCLC or SCLC when treated with avasopasem. NCI CTCAE Grading: Grade 1: asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2: symptomatic; altered eating/swallowing; oral supplements indicated Grade 3: severely altered eating/swallowing; tube feeding, total parental nutrition (TPN) or hospitalization Grade 4: life-threatening consequences; urgent operative intervention indicated Grade 5: death

2 secondary outcomes

Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through 4 Weeks After Completion of Chemoradiotherapy
Time frame: From the first radiation therapy fraction through 4 weeks after the completion of chemoradiotherapy, which is estimated to be 10 weeks
Number of Subjects With Acute Severe Radiation Esophagitis (Defined as Grade 3-4; NCI CTCAE Version 5) Through Completion of Chemoradiotherapy.
Time frame: From the first radiation therapy fraction through the completion of chemoradiotherapy, which is estimated to be 6 weeks.

Results and safety

Results posted to the registry on 23 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GC4419	39	15

Primary outcome: Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through the End of Chemoradiotherapy for Non-Small Cell Lung (NSCLC) or Small Cell Lung Cancer (SCLC) When Avasopasem Was Added.

Time frame: From the first radiation therapy fraction through the end of the study treatment period, which is estimated to be 6 weeks.. Count of participants. Unit: Participants

Measure	GC4419 (Avasopasem Manganese) n = 32
Condition Not Present	7
Grade 1	6
Grade 2	17
Grade 3	2
Grade 4	0
Grade 5	0

Population analysed: Primary Efficacy Population included all subjects who received at lease 1 dose of GC4419 (avasopasem manganese) and either completed their radiation therapy or discontinued their radiation therapy early but were known to have had acute radiation esophagitis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from baseline (Study Day 1) until 30 days post the last day of radiation therapy (approximately 10 weeks).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GC4419	15 of 39 (38.5%)	39 of 39 (100%)	11 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Esophagitis

Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Not yet recruitingPhase 3
Risk-Adapted Segmental Esophagus-Sparing Radiotherapy for Definitive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eugene Kennedy, MD study chair

Chief Medical Officer

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GC4419 (avasopasem manganese) in people with Esophagitis, run by Galera Therapeutics, Inc. at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through the End of Chemoradiotherapy for Non-Small Cell Lung (NSCLC) or Small Cell Lung Cancer (SCLC) When Avasopasem Was Added. (time frame: From the first radiation therapy fraction through the end of the study treatment period, which is estimated to be 6 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04225026.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.