A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer
NCT ID: NCT02508389
Last Updated: 2021-09-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
223 participants
INTERVENTIONAL
2015-10-12
2019-08-29
Brief Summary
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Detailed Description
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Arm A: 30 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for 3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).
Arm B: 90 mg GC4419 per day (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for 3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).
Arm C: Placebo daily (60 min IV infusion to complete within 60 minutes prior to IMRT), concurrent with daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for 3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).
Planned radiation fields in all 3 arms must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) with each site receiving a dose of at least 50 Gy.
All patients will be assessed twice weekly for oral mucositis per WHO grading criteria until the completion of IMRT, and once weekly thereafter (if necessary) for 8 weeks, or until oral mucositis resolves to ≤ Grade 1.
Approximately 200 total to ensure that roughly 60 patients per arm receive study drug and complete requirements for primary endpoint analysis, which is defined as patients receiving a minimum cumulative dose of 60 Gy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Low Dose GC4419: 30mg/day
30 mg GC4419/day prior to IMRT
Low Dose GC4419: 30mg/day
Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy
Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin
Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
High Dose GC4419: 90mg/day
90 mg GC4419/day prior to IMRT
High Dose GC4419: 90mg/day
High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy
Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin
Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
Placebo
Placebo daily, prior to IMRT
Placebo
Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy
Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin
Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
Interventions
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Low Dose GC4419: 30mg/day
Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
High Dose GC4419: 90mg/day
High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Placebo
Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
Intensity-Modulated Radiation Therapy
Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
Cisplatin
Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor
Eligibility Criteria
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Inclusion Criteria
3. Treatment plan to receive standard cisplatin monotherapy administered either every three weeks (80-100 mg/m2 for 3 doses) or weekly (30-40 mg/m2 for 6-7 doses). The decision on which chemotherapy regimen to use in combination with IMRT and GC4419 will be at the discretion of the investigator.
4. Age 18 years or older
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
6. Adequate hematologic function as indicated by:
* Absolute neutrophil counts (ANC) ≥ 1,500/mm3
* Hemoglobin (Hgb) ≥ 9.0 g/dL
* Platelet count ≥ 100,000/mm3
7. Adequate renal and liver function as indicated by:
* Serum creatinine acceptable for treatment with cisplatin per institutional guidelines
* Total bilirubin ≤ 1.5 x upper-normal limit (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
* Alkaline phosphatase ≤ 2.5 x ULN
8. Human papilloma virus (HPV) status in tumor has been documented using tumor immunohistochemistry for HPV-p16 or other accepted test
9. Serum pregnancy test negative for females of childbearing potential
10. Males and females must agree to use effective contraception starting prior to the first day of treatment and continuing for 30 days after the last dose of GC4419
11. Properly obtained written informed consent
Exclusion Criteria
2. Metastatic disease (Stage IV C)
3. Prior radiotherapy to the region of the study cancer or adjacent anatomical sites or more than 25% of total body marrow-bearing area (potentially interfering with chemotolerance)
4. Prior induction chemotherapy
5. Receiving any approved or investigational anti-cancer agent other than those provided for in this study
6. Participation in another clinical trial or use of another investigational agent within 30 days of study entry
7. Requirement for significantly modified diet (liquids and/or solids) due to compromised oral/pharyngeal function at baseline
8. Requirement at baseline for parenteral or gastrointestinal tube-delivered nutrition for any reason
9. Malignant tumors other than head and neck cancer (HNC) within the last 5 years, unless treated definitively and with low risk of recurrence in the judgment of the treating investigator
10. Active infectious disease excluding oral candidiasis
11. Presence of oral mucositis (World Health Organization Score ≥ Grade 1) at study entry
12. Known history of HIV or active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible)
13. Female patients who are pregnant or breastfeeding
14. Known allergies or intolerance to cisplatin and similar platinum-containing compounds
15. Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
18 Years
ALL
No
Sponsors
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Galera Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jon T Holmlund, MD
Role: STUDY_CHAIR
Chief Medical Officer
Locations
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University of Arizona Cancer Center at Dignity Health St. Joseph's
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Fowler Family Center for Cancer Care
Jonesboro, Arkansas, United States
University of Arkansas for Medical Sciences- Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, United States
VA Long Beach Healthcare System
Long Beach, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Clinical Trials and Research Associates, Inc.
Montebello, California, United States
UC Irvine Chao Family Comprehensive Cancer Center
Orange, California, United States
Stanford Cancer Institute
Stanford, California, United States
St. Mary's Regional Cancer Center
Grand Junction, Colorado, United States
UConn Health School of Dental Medicine
Farmington, Connecticut, United States
Pasco Pinellas Cancer Center
Holiday, Florida, United States
Lakeland Regional Health Cancer Center
Lakeland, Florida, United States
UF Health Cancer Center at Orlando Health
Orlando, Florida, United States
Sacred Heart Medical Oncology Group
Pensacola, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Indianan, Goshen Center for Cancer Care
Goshen, Indiana, United States
Department of Radiation Oncology University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Ashland-Bellefonte Cancer Center
Ashland, Kentucky, United States
University of Kentucky, Albert B. Chandler Medical Center
Lexington, Kentucky, United States
University of Louisville Hospital, James Graham Brown Cancer Center
Louisville, Kentucky, United States
Tulane Cancer Center
New Orleans, Louisiana, United States
CHRISTUS Schumpert Cancer Treatment Center
Shreveport, Louisiana, United States
Baystate Regional Cancer Program
Springfield, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Allegiance Health
Jackson, Michigan, United States
Lake Huron Medical Center
Port Huron, Michigan, United States
Ellis Fichel Cancer Center, University of Missouri
Columbia, Missouri, United States
Billings Clinic
Billings, Montana, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Renown Cancer Institute
Reno, Nevada, United States
Hunterdon Hematology Oncology, LLC Hunterdon Regional Cancer Center
Flemington, New Jersey, United States
Jersey Shore University Medical Center- Hackensack Meridian Health
Neptune City, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, United States
East Carolina University, Leo W. Jenkins Cancer Center
Greenville, North Carolina, United States
Marion L. Shepard Cancer Center
Washington, North Carolina, United States
Wake Forest Health
Winston-Salem, North Carolina, United States
Ohio State University, James Cancer Center
Columbus, Ohio, United States
Toledo Clinic Cancer Center
Toledo, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
VA Portland Health Care System
Portland, Oregon, United States
St. Luke's University Health Network
Easton, Pennsylvania, United States
Thomas-Jefferson University Hospital-Bodine Center for Cancer Treatment
Philadelphia, Pennsylvania, United States
Allegheny General Hospital, Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
Charleston Cancer Center
Charleston, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Prairie Lakes Health Care System
Watertown, South Dakota, United States
Mountain States Health Alliance
Johnson City, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Texas Oncology
Plano, Texas, United States
Scott and White Memorial Hospital and Clinic
Temple, Texas, United States
Hope Cancer Center
Tyler, Texas, United States
The University of Vermont Medical Center
Burlington, Vermont, United States
Providence Regional Medical Center
Everett, Washington, United States
VA Puget Sound Health Care System
Seattle, Washington, United States
Cancer Care Northwest
Spokane, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Northeast Cancer Centre, Health Sciences North
Greater Sudbury, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-centre-du-Québec
Trois-Rivières, Quebec, Canada
Fundación de Investigación
San Juan, PR, Puerto Rico
Countries
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References
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Mapuskar KA, Vasquez Martinez G, Pulliam CF, Petronek MS, Steinbach EJ, Monga V, Furqan M, Jetton JG, Saunders DP, Pearce A, Davidson S, Pitre L, Dunlap NE, Fairbanks R, Lee CM, Mott SL, Bodeker KL, Cl H, Buatti JM, Anderson CM, Beardsley RA, Holmlund JT, Zepeda-Orozco D, Spitz DR, Allen BG. Avasopasem manganese (GC4419) protects against cisplatin-induced chronic kidney disease: An exploratory analysis of renal metrics from a randomized phase 2b clinical trial in head and neck cancer patients. Redox Biol. 2023 Apr;60:102599. doi: 10.1016/j.redox.2022.102599. Epub 2023 Jan 3.
Anderson CM, Lee CM, Saunders D, Curtis AE, Dunlap NE, Nangia C, Lee AS, Kovoor P, Bar-Ad V, Pedadda AV Jr, Holmlund J, Downs M, Sonis ST. Two-Year Tumor Outcomes of a Phase 2B, Randomized, Double-Blind Trial of Avasopasem Manganese (GC4419) Versus Placebo to Reduce Severe Oral Mucositis Owing to Concurrent Radiation Therapy and Cisplatin for Head and Neck Cancer. Int J Radiat Oncol Biol Phys. 2022 Nov 1;114(3):416-421. doi: 10.1016/j.ijrobp.2022.06.063. Epub 2022 Jun 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GT-201
Identifier Type: -
Identifier Source: org_study_id
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