A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Radiation Induced Oral Mucositis

In brief

The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.

Key facts

Study ID

NCT02508389

Run by

Galera Therapeutics, Inc.

People needed

223

Starts

2015-10-12

Expected to finish

2019-08-29

Last updated by the study team

2021-09-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically-confirmed diagnosis of squamous cell carcinoma of the head and neck, defined as SCC of the oral cavity or oropharynx that will be treated with cisplatin plus concurrent IMRT Note: Patients with unknown primary tumors whose treatment plan matches the requirements specified in Inclusion Criteria #2 and #3 below are eligible for the trial.
• Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose between 60 Gy and 72 Gy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) that are each planned to receive a total of > 50 Gy. Patients who have had prior surgery are eligible, provided they have fully recovered from surgery, and patients who may have surgery in the future are eligible.
• 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.
• Age 18 years or older
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Adequate hematologic function as indicated by:
• Absolute neutrophil counts (ANC) ≥ 1,500/mm3
• Hemoglobin (Hgb) ≥ 9.0 g/dL
• Platelet count ≥ 100,000/mm3
• 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
• Human papilloma virus (HPV) status in tumor has been documented using tumor immunohistochemistry for HPV-p16 or other accepted test
• Serum pregnancy test negative for females of childbearing potential
• 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
• Properly obtained written informed consent

You may not qualify if…

• Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
• Metastatic disease (Stage IV C)
• 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)
• Prior induction chemotherapy
• Receiving any approved or investigational anti-cancer agent other than those provided for in this study
• Participation in another clinical trial or use of another investigational agent within 30 days of study entry
• Requirement for significantly modified diet (liquids and/or solids) due to compromised oral/pharyngeal function at baseline
• Requirement at baseline for parenteral or gastrointestinal tube-delivered nutrition for any reason
• 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
• Active infectious disease excluding oral candidiasis
• Presence of oral mucositis (World Health Organization Score ≥ Grade 1) at study entry
• 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)
• Female patients who are pregnant or breastfeeding
• Known allergies or intolerance to cisplatin and similar platinum-containing compounds
• 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

Where it is running

• 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 Arizona Cancer Center at Dignity Health St. Joseph's — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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