Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer

Galera Therapeutics

Status and phase: Completed; Phase 2

Conditions: Oral Mucositis; Head and Neck Cancer

Treatments: Radiation: Intensity-modulated radiation therapy (IMRT); Drug: Drug: GC4419; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04529850

GTI-4419-202

Details and patient eligibility

About

GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)

Full description

Subjects will receive 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 100 mg/m2 once every three weeks for 3 doses or 40 mg/m2 once weekly for 6-7 doses (Investigator's choice).

All subjects will be assessed twice weekly for Oral Mucositis (OM) per WHO grading criteria until 28 days post end of study treatment period (last day of IMRT).

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pathologically-confirmed diagnosis of locally advanced squamous cell carcinoma of the head and neck that will be treated with cisplatin plus concurrent IMRT.
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.
3. Patients who have had prior surgery may be 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).
5. Age 18 years or older
6. ECOG performance status ≤ 2
7. Adequate hematologic function
8. Adequate renal and liver function Alkaline phosphatase ≤ 2.5 ULN

Exclusion criteria

1. Metastatic disease
2. Prior radiotherapy to the region of the study cancer or adjacent anatomical sites
3. Prior induction chemotherapy or plans for chemotherapy to be administered only sequentially with IMRT
4. Planned concurrent chemotherapy other than single agent cisplatin
5. Receiving any approved or investigational anti-cancer agent
6. Concurrent participation in another interventional clinical study
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
9. Malignant tumors other than head and neck cancer (HNC) within the last 5 years
10. Active infectious disease excluding oral candidiasis
11. Presence of oral mucositis at baseline.
12. Known history of human immunodeficiency virus (HIV) or active hepatitis B/C
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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

38 participants in 1 patient group

Open Label Active Arm

Experimental group

Description:

90mg GC4419 by IV

Treatment:

Drug: Cisplatin

Drug: Drug: GC4419

Radiation: Intensity-modulated radiation therapy (IMRT)