NCT07192588 - A Study of GR1014 Cutaneous Gel for the Prevention of Skin Reactions Caused by Radiation Therapy for Breast Cancer | Biotech Hunter

Enrollment

273

Participants

Timeline

Start Date

July 26, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

October 30, 2026

Conditions

Radiodermatitis; Acute

Interventions

DRUG

GR1014-CG 2.4%

Topical gel formulation of amifostine thiol (GR1014) at 25 mg/mL

DRUG

Vehicle Gel

The same topical formulation as GR1014-CG without the active ingredient amifostine thiol

RADIATION

Radiation Therapy

Ultra hypofractionated RT, 26 Gy in 5 daily fractions (5.2 Gy) given over 1 week on the whole breast

DRUG

GR1014-CG 4.7%

Topical gel formulation of amifostine thiol (GR1014) at 50 mg/mL

Trial Locations (4)

Institut Bergonié, Bordeaux

Centre Léon Bérard, Lyon

Institut Gustave Roussy, Villejuif

The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Sutton