ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients

Galera Therapeutics

Status and phase: Completed; Phase 3

Conditions: Oral Mucositis

Treatments: Drug: Placebo; Drug: GC4419 90mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03689712

GTI-4419-301

Details and patient eligibility

About

The purpose of the phase 3, clinical study is to determine if GC4419 (avasopasem manganese) administered prior to intensity-modulated radiation therapy (IMRT) reduces the 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.

Enrollment: 455 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• squamous cell carcinoma of the head and neck
• treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy
• Treatment plan to receive standard cisplatin monotherapy
• Age 18 years or older
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Adequate hematologic, renal and liver function
• Negative serum pregnancy test
• Use of effective contraception

Exclusion criteria

• Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
• Metastatic disease
• Prior radiotherapy to the region of the study cancer or adjacent anatomical
• Prior induction chemotherapy
• Receiving any approved or investigational anti-cancer agent other than those provided for in this study
• Concurrent participation in another interventional clinical study
• Inability to eat soft solid food at baseline
• Malignant tumors other than HNC within the last 5 years
• Active infectious disease excluding oral candidiasis
• Presence of oral mucositis at baseline
• Known history of HIV or active hepatitis B/C
• 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 create a risk for a precipitous decrease in blood pressure

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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455 participants in 2 patient groups, including a placebo group

GC4419 (avasopasem manganese) 90 mg

Experimental group

Treatment:

Drug: GC4419 90mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo