GuARD: GR1014 cutaneous gel Against Radiation Dermatitis

Phase 1

Recruiting

• Conditions: Radiation-induced dermatitis (radiodermatitis); MedDRA version: 24.1Level: LLTClassification code: 10061103Term: Dermatitis radiation Class: 10022117; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2023-508728-36-00
• Lead Sponsor: Graegis Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-31
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 273

Inclusion Criteria

Dated, signed informed consent obtained from individuals who agree to participate in the study., Female patients with age =18 years. Those of childbearing potential must be using highly effective contraception methods during the study and for 6 months after the last administration of the study treatment and have a negative pregnancy test at screening and no more than 10 days prior to the administration of the first dose of study treatment., Patients with primary, localised breast cancer without metastases pT1--3, pN0--N1mi, M0, who have undergone breast-conserving surgical excision and require adjuvant RT. If adjuvant chemotherapy is delivered, the patient must be randomised within 4 weeks after the last series of adjuvant chemotherapy. If no adjuvant chemotherapy is delivered, the patient must be randomised within 8 weeks from the last surgery. The patient can be included no matter the status of oestrogen and progesterone receptors, malignancy grade, or HER2 status., Eastern Cooperative Oncology Group (ECOG) performance status 0-2., Patients to be treated with ultra hypofractionated RT, 26 Gy in 5 fractions (5.2 Gy) on whole breast (EQD2 > 42.6 Gy for a/ß of 3)., Patients with no signs of dermatitis in the breast area to be irradiated, i.e., assessed Grade 0 as per CTCAE LV radiation dermatitis grading., Patients whom the investigator has deemed able to comply with the RT and investigational treatment done under the supervision of the medical personnel throughout the study period., Patients affiliated with the Social Security System (France)., Patients who have completed the appropriate washout period for any prior interventions or treatments.

Exclusion Criteria

Pregnant and breastfeeding women., Patients under any treatment concomitant to RT tested in another clinical study., Allergies to any of the ingredients in GR1014-CG, Patients protected by law (legal guardianship or protection)., Patients unable to adhere to the requirements of the study., History of thoracic RT., Participants with the presence of skin rash, ulceration, unhealed surgical wounds, biopsy sites, or open wound in the breast or chest area at visit 2., Patients suffering from scleroderma, auto-immune disease, micro-vascular diseases, collagen tissue diseases, lupus, pre-existing loss of skin integrity, active eczema in the region to be treated or with a history of any of the following: drug-induced severe cutaneous adverse reaction (SCAR; including, but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis [SJS/TEN], or drug reaction with eosinophilia and systemic symptoms).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified