An Open Label Multi-Center Study of the Effects of Superoxide Dismutase Mimetic GC4419 when Administered to Reduce the Incidence and Severity of Severe Oral Mucositis (SOM) Associated with Chemoradiotherapy for Locally Advanced, NonMetastatic Head and Neck Cancer

Galera Therapeutics, Inc.0 sites70 target enrollmentOctober 23, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Severe Oral Mucositis (SOM) Associated with Chemoradiotherapy for Locally Advanced, Non-Metastatic Head and Neck Cancer
Sponsor: Galera Therapeutics, Inc.
Enrollment: 70
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

October 23, 2019

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Pathologically\-confirmed diagnosis of locally advanced squamous cell carcinoma of the head and neck 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 study.
•2\. 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 of 60\-72 Gy. Planned radiation fields must include at least 2 oral sites (left and right buccal mucosa, floor of mouth, left and right lateral tongue, soft palate) with each site receiving a cumulative dose of at least 50 Gy.
•Note: Unavoidable doses of at least 50 Gy, to include entrance, exit, and scatter doses, still constitute planned radiation.
•3\. 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.
•4\. Treatment plan to receive standard cisplatin monotherapy administered either every three weeks (100 mg/m2 for 3 doses) or weekly (40 mg/m2 for 6\-7 doses). The decision on which cisplatin regimen to use in combination with IMRT and GC4419 will be at the discretion of the Investigator.
•5\. Age 18 years or older
•6\. Eastern Cooperative Oncology Group (ECOG) performance status \= 2
•7\. Adequate hematologic function as indicated by:
•\- Absolute neutrophil counts (ANC) \= 1,500/mm3

•1\. Metastatic disease
•2\. 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 chemo\-tolerance)
•3\. Prior induction chemotherapy or plans for chemotherapy to be administered only sequentially, not concurrently, with IMRT
•4\. Planned concurrent chemotherapy other than single agent cisplatin
•5\. Receiving any approved or investigational anti\-cancer agent other than those provided for in this study
•6\. Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days of first dose of GC4419
•Note: Patients who are participating in non\-interventional clinical studies (e.g., QOL, imaging, observational, follow\-up studies, etc.) are eligible, regardless of the timing of participation.
•7\. Inability to eat soft solid food at baseline for reasons other than mouth soreness after surgery or dental procedures
•8\. Complete reliance on parenteral or gastrointestinal tube\-delivered nutrition at baseline
•Note: Patients who have gastrostomy tubes prophylactically placed are eligible. Patients receiving supplemental nutrition through a gastrostomy tube at baseline may be eligible depending on diet.