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Lack of study enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC4419 (avasopasem manganese) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC4419 (avasopasem manganese) | Drug | 90 mg, by 60-minute IV infusion, prior to each fraction of RT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the first radiation therapy fraction through the end of the study treatment period, which is estimated to be 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Kennedy, MD | Chief Medical Officer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Tampa General Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | GC4419 | GC4419: 90 mg, by 60-minute IV infusion, prior to each fraction of RT |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2021 |
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| 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. | From the first radiation therapy fraction through the completion of chemoradiotherapy, which is estimated to be 6 weeks. |
| Tampa |
| Florida |
| 33606 |
| United States |
| IACT Health | Columbus | Georgia | 31904 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Cancer Care St. Joseph/Mosaic Life Care | Saint Joseph | Missouri | 64507 | United States |
| Hackensack Meridian Health | Montclair | New Jersey | 07753 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| St. Francis Hospital | Greenville | South Carolina | 29601 | United States |
| Spartanburg Regional Medical Center - Gibbs Cancer Center | Spartanburg | South Carolina | 29303 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | United States |
|
| Primary Efficacy Population |
|
| Per Protocol Population | The Per Protocol Population included those subjects that completed chemoradiotherapy and at least 5 weeks of GC4419 |
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| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | GC4419 | GC4419: 90 mg, by 60-minute IV infusion, prior to each fraction of RT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Sex: Female, Male | 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. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Race (NIH/OMB) | 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. | Count of Participants | Participants |
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| Region of Enrollment | 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. | Number | participants |
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| Type of Lung Cancer | 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. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Posted | Count of Participants | Participants | From the first radiation therapy fraction through the end of the study treatment period, which is estimated to be 6 weeks. |
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| Secondary | 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 | 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. | Posted | Count of Participants | Participants | From the first radiation therapy fraction through 4 weeks after the completion of chemoradiotherapy, which is estimated to be 10 weeks |
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| Secondary | 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. | Per protocol population defined as those subjects completing chemoradiation therapy and at least 5 weeks of GC4419 | Posted | Count of Participants | Participants | From the first radiation therapy fraction through the completion of chemoradiotherapy, which is estimated to be 6 weeks. |
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Adverse events were collected from baseline (Study Day 1) until 30 days post the last day of radiation therapy (approximately 10 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GC4419 | GC4419: 90 mg, by 60-minute IV infusion, prior to each fraction of RT | 11 | 39 | 15 | 39 | 39 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Adult Failure to Thrive | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Corona Virus Infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Lung Infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
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| Non Cardiac Chest Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
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| Vascular Access Complication | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
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| Embolism | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
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| Atrial Tachycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
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| Confusional State | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paraesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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The Institution shall provide Sponsor with an advance copy of any proposed publication at least 45 days prior to the planned date of submission or presentation and Sponsor shall have 45 days to review. Institution may be asked by Sponsor to delete confidential information, consider reasonable changes requested by Sponsor or delay proposed submission for additional period, not to exceed 90 days, to protect the potential patentability of any technology.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judy Schnyder, Sr. Vice President, Clinical Operations | Galera Therapeutics | 484-870-9625 | jschnyder@galeratx.com |
| Nov 10, 2022 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004941 | Esophagitis |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
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| ID | Term |
|---|---|
| C000707700 | avasopasem manganese |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Grade 3 |
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| Grade 4 |
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| Grade 5 |
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