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

Recruiting in Palo Alto (17 mi)

+96 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Galera Therapeutics, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Gene Kennedy, MD

Principal Investigator

Galera Therapeutics

Eligibility Criteria

Inclusion Criteria

A patient who has a cancer diagnosis and an ECOG performance status of ≤ 2 is generally considered to be a good candidate for cancer treatment.

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

Adequate hematologic, renal and liver function

Exclusion Criteria

You are unable to eat soft solid food at the beginning of the study.

Malignant tumors other than HNC within the last 5 years

Active infectious disease excluding oral candidiasis

Treatment Details

Interventions

• GC4419 (Manganese-containing Superoxide Dismutase Mimetic)

Participant Groups

Group I: GC4419 (avasopasem manganese) 90 mg Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Galera Therapeutics, Inc.

Lead Sponsor

Trials

17

Recruited

1,400+