CLINICAL TRIALS PROFILE FOR OMAVELOXOLONE
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All Clinical Trials for OMAVELOXOLONE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02029729 ↗ | RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER | Completed | AbbVie | Phase 1 | 2013-12-01 | This proposed first-in-human study (408-C-1303) is designed to assess the safety, maximum tolerated dose, pharmacodynamics, and pharmacokinetics of omaveloxolone (RTA 408) in patients with advanced solid tumors that are refractory after standard of care therapy for the disease. The results of this study will help provide clinical information for the design and conduct of further clinical studies with RTA 408 in cancer patients. |
| NCT02029729 ↗ | RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER | Completed | Reata Pharmaceuticals, Inc. | Phase 1 | 2013-12-01 | This proposed first-in-human study (408-C-1303) is designed to assess the safety, maximum tolerated dose, pharmacodynamics, and pharmacokinetics of omaveloxolone (RTA 408) in patients with advanced solid tumors that are refractory after standard of care therapy for the disease. The results of this study will help provide clinical information for the design and conduct of further clinical studies with RTA 408 in cancer patients. |
| NCT02128113 ↗ | RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD | Completed | AbbVie | Phase 2 | 2014-05-01 | This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery. |
| NCT02128113 ↗ | RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD | Completed | Reata Pharmaceuticals, Inc. | Phase 2 | 2014-05-01 | This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery. |
| NCT02142959 ↗ | RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE | Completed | AbbVie | Phase 2 | 2014-06-01 | 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. |
| NCT02142959 ↗ | RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE | Completed | Reata Pharmaceuticals, Inc. | Phase 2 | 2014-06-01 | 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. |
| NCT02255422 ↗ | RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR | Completed | AbbVie | Phase 2 | 2015-05-05 | Mitochondrial myopathies are a multisystemic group of disorders that are characterized by a wide range of biochemical and genetic mitochondrial defects and variable modes of inheritance. Currently there are no effective treatments for this disease. Despite the heterogeneous myopathy phenotypes, a unifying feature of mitochondrial myopathies is that the pathogenic mtDNA mutations and/or nuclear mutations of the electron transport chain invariably lead to dysfunctional mitochondrial respiration. This reduction in mitochondrial respiration leads to a reduced ability to produce cellular adenosine triphosphate (ATP), often resulting in muscle weakness, exercise intolerance, and fatigue in patients with mitochondrial myopathies. RTA 408 is a potent activator of Nrf2 and inhibitor of NF κB (nuclear factor kappa-light-chain-enhancer of activated B cells), and thus induces an antioxidant and anti-inflammatory phenotype. Several lines of evidence suggest that Nrf2 activation can increase mitochondrial respiration and biogenesis. Collectively, available data suggest that the ability of RTA 408 to activate Nrf2 and induce its target genes could potentially improve muscle function, oxidative phosphorylation, antioxidant capacity, and mitochondrial biogenesis in patients with mitochondrial myopathies. This study will be a randomized, placebo-controlled, double-blind, dose-escalation study to evaluate the safety of omaveloxolone (RTA 408) at various doses in patients with mitochondrial myopathies. |
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