| |
 |
Phase I/II: Pancreatic Cancer |
| |
Phase I will be conducted to determine the maximum tolerated dose (MTD) of RTA 402 in combination with gemcitabine. The phase II portion of the study will be randomized, and double-blinded. Phase II will utilize the RTA 402 MTD determined in Phase I to determine whether treatment with RTA 402 in combination with gemcitabine can increase the progression-free survival versus gemcitabine alone. View Trial >
|
|
Phase IIa in Diabetic Nephropathy |
| |
Bardoxolone is an Antioxidant Inflammation Modulator (AIM) in clinical development for inflammation and cancer-related indications that inhibits immune-mediated inflammation by restoring redox homeostasis in inflamed tissues. It induces the cytoprotective transcription factor Nrf2 and suppresses the activities of the pro-oxidant and pro-inflammatory transcription factors NF-kB and the STATs. In vivo, bardoxolone has demonstrated significant single agent anti-inflammatory activity in several animal models of inflammation such as renal damage in the cisplatin model and ischemia-reperfusion model of acute renal injury. In addition, significant reductions in serum creatinine have been observed in patients treated with bardoxolone. Based on these data, it is hypothesized that bardoxolone can improve renal function in patients with diabetic nephropathy through suppression of renal inflammation and improvement of glomerular filtration.
This open-label, randomized trial is to determine the effects of RTA 402 administered orally at three dose strengths on the glomerular filtration rate (as estimated by the MDRD formula) in patients with diabetic nephropathy. View Trial >
|
|
| |
|
Phase II: Leptomeningeal Disease |
| |
Leptomeningeal metastases is a common oncologic complication representing spread of tumor cells to the subarachnoid space of the brain, a complication which often portends a very short prognosis. This disease is found in 20% of cancer patients at autopsy and is most common in breast cancer, small cell lung cancer, and melanoma. Currently, mean survival time following diagnosis is 4 weeks without treatment and 6 months with appropriate therapy.
Berubicin, a novel chemical analogue of doxorubicin, has shown ability to cross the blood brain barrier and to achieve high concentration in CNS tumor tissue in animal models. This study's objectives are to determine the tolerability of berubicin injection, to characterize the multiple-dose pharmacokinetics, and document any potential antitumor activity. View Trial >
|
|
Phase II: Brain Metastases |
| |
Berubicin is a novel, anthracycline that has shown the ability to penetrate across the blood brain barrier. In a Phase I safety study, berubicin was shown to be generally well tolerated in patients with recurrent gliolastoma multiforme (GBM). Additionally, anti-tumor activity was observed.
Breast cancer is known to be sensitive to anthracycline therapy. Based on the preliminary Phase I clinical results and the sensitivity of breast cancer to anthracycline therapy, this Phase II study will investigate the safety and efficacy of berubicin in patients with breast cancer and metastatic disease to the brain which has progressed following whole brain irradiation. View Trial >
|
|
