RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE

Summary

Radiation dermatitis is experienced by almost all patients (up to 95%) receiving radiation therapy for cancer. Radiation dermatitis can be a serious condition because, in addition to its direct physical complications and the resulting impact on overall quality of life, it can also be a dose-limiting toxicity requiring changes to the prescribed course of radiation therapy. The most common strategy employed in an attempt to prevent or minimize radiation dermatitis involves moisturization of the irradiated area, use of a mild soap to keep the area clean, and minimizing exposure to potential mechanical irritants, such as scratching and rough clothing. However, this strategy has been shown to lack clinically significant efficacy. Consequently, there is a clinical need for new treatments that are effective in protecting against radiotherapy-induced oxidative stress and the subsequent development of radiation dermatitis. Based on data from previous studies in animals and humans, Reata believes that omaveloxolone (RTA 408) Lotion may effectively prevent and mitigate radiation dermatitis in oncology patients undergoing radiation therapy. This randomized, double-blind, vehicle-controlled, parallel-group trial will study the efficacy, tolerability and safety of two concentrations of omaveloxolone (RTA 408) Lotion (3% and 0.5%) versus vehicle in patients with breast cancer for whom radiation therapy is recommended.

Timeline

Start

2014-06-30

Primary completion

2015-04-30

Completion

2015-04-30

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry Omaveloxolone (RTA 408) Lotion 0.5% vs Vehicle Lotion; p >0.05 NCT02142959 ↗

registry Omaveloxolone (RTA 408) Lotion 3% vs Vehicle Lotion; p >0.05 NCT02142959 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omaveloxolone	Small molecule	0.5 %	Topical
Subject	Omaveloxolone	Small molecule	3 %	Topical

Indications