Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Lung Neoplasms

Esophagitis

Esophageal Diseases

Gastrointestinal Diseases

Gastroenteritis

Micronutrients

All Drugs and Chemicals

Manganese

Avasopasem manganese

Trace Elements

Antioxidants

Protective Agents

90 mg, by 60-minute IV infusion, prior to each fraction of RT

GC4419 (avasopasem manganese)

Eugene Kennedy, MD

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 Cell Lung Cancer (SCLC) treatable with chemoradiotherapy.

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

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

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

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

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.

Galera Therapeutics, Inc.

GC4419: 90 mg, by 60-minute IV infusion, prior to each fraction of RT

GC4419

There were 39 subjects enrolled to the study but only 35 subjects were included in the primary efficacy analysis population based on the primary efficacy population definition.

Age, Continuous

Their were 39 subjects enrolled to the study but only 35 subjects were included in the analysis population based on the primary efficacy population definition.

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

NSCLC

SCLC

Type of Lung Cancer

The primary efficacy population includes all subjects who received at least one dose of GC4419 and either a.) completed their radiation therapy course of treatment or b.) discontinued their radiation therapy course of treatment but are known to have had acute radiation esophagitis.

Judy Schnyder, Sr. Vice President, Clinical Operations

Condition Not Present

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

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

GC4419 (Avasopasem Manganese)

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.

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.

Number of Subjects With of Acute Radiation Esophagitis (Defined as Grade >/= 2; NCI CTCAE Version 5) Through 4 Weeks After Completion of Chemoradiotherapy

Per protocol population defined as those subjects completing chemoradiation therapy and at least 5 weeks of GC4419

Spots Global Cancer Trial Database for gc4419 (avasopasem manganese)