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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04225026
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Galera Therapeutics, Inc.

Brief Summary:
GTI-4419-203 will be an open-label, multi-center study to evaluate GC4419 administered intravenous (IV) for the reduction of radiation induced esophagitis in subjects receiving chemoradiotherapy for unresectable Stage 3A/3B or post-operative Stage 2B NSCLC, SCLC treatable with chemoradiotherapy.

Condition or disease Intervention/treatment Phase
Esophagitis Drug: GC4419 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 19, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GC4419 Drug: GC4419
90 mg, by 60-minute IV infusion, prior to each fraction of RT




Primary Outcome Measures :
  1. Cumulative incidence of acute radiation esophagitis [ Time Frame: From the first RT fraction through the end of the study treatment period, which is estimated to be 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. 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%
  3. Age 18 years or older
  4. ECOG performance status ≤ 2
  5. Adequate hematologic, renal and liver function
  6. Use of highly effective contraception

Exclusion Criteria:

  1. Metastatic disease
  2. Prior radiation therapy to the region of the study cancer
  3. Subjects not receiving chemotherapy
  4. Grade 2 or greater esophagitis at baseline
  5. Inability to provide information in the electronic symptom-reporting device
  6. Receiving any approved or investigational immunotherapy, targeted therapy, hormone therapy, or biologic therapy
  7. Participation in another clinical trial or use of another investigational agent within 30 days of first does of GC4419
  8. Malignant tumors other than the current lung cancer within the last 5 years
  9. Previous diagnosis of pneumonitis
  10. Untreated, active infectious disease requiring systemic anti-infective therapy
  11. Untreated HIV or active hepatitis B/C
  12. Females who are pregnant or breastfeeding
  13. Known allergies or intolerance to chemotherapy and similar platinum-containing compounds
  14. Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure
  15. Clinically significant heart disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225026


Contacts
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Contact: Amanda Sanders 484-870-9622 asanders@galeratx.com

Locations
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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Racine Romero       Racine.Romero@bannerhealth.com   
Principal Investigator: Gary Walker, MD         
United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Elliott White    813-844-4316      
Principal Investigator: Lawrence Berk, MD         
United States, Georgia
IACT Health Recruiting
Columbus, Georgia, United States, 31904
Contact: Grayson Scott    706-321-0495      
Principal Investigator: Douglas Ciuba, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Nancy Hollenbeck    319-356-7611      
Principal Investigator: Bryan Allen, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Kelli Deviney    502-333-6934    kelli.deviney@louisville.edu   
Principal Investigator: Neal Dunlap, MD         
United States, Missouri
Cancer Care St. Joseph/Mosaic Life Care Recruiting
Saint Joseph, Missouri, United States, 64507
Contact: Jessica Yingling    816-271-7390    Jessica.Yingling@mymlc.com   
Principal Investigator: Bonnie Goins, MD         
United States, New Jersey
Hackensack Meridian Health Recruiting
Montclair, New Jersey, United States, 07753
Contact: Diane Doherty    732-776-3466      
Principal Investigator: Douglas Miller, MD         
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Ellen Perme       Ellen.Perme@UHhospitals.org   
Principal Investigator: Monaliben Patel, MD         
United States, South Carolina
St. Francis Hospital Recruiting
Greenville, South Carolina, United States, 29601
Contact: Jennifer Kenrick    864-603-6216      
Principal Investigator: Robert Siegel, MD         
Spartanburg Regional Medical Center - Gibbs Cancer Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Susan Stanley    864-560-7252      
Principal Investigator: Amarintha Curtis, MD         
United States, Tennessee
University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Brenna Adelman    865-305-5131      
Principal Investigator: Joseph Kelley, MD         
United States, Washington
Providence Regional Cancer Partnership Recruiting
Everett, Washington, United States, 98201
Contact: Courtney Nichols    425-261-3544      
Principal Investigator: William Wisbeck, MD         
Sponsors and Collaborators
Galera Therapeutics, Inc.
Investigators
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Study Chair: Jon T Holmlund, MD Chief Medical Officer
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Responsible Party: Galera Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04225026    
Other Study ID Numbers: GTI-4419-203
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis