Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer

A Phase II Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer

This study is to evaluate the benefits of investigational drug, NRX 194204 in slowing down/stopping/reversing progression of the castration resistant and taxane resistant prostate cancer.

Numerous studies in pre-clinical models and in human clinical trials have clearly established the potential for the use of rexinoids in the treatment and prevention of cancer. NRX 194204, a second generation rexinoid, is a highly potent and specific activator of RXRs (retinoid X receptors). Because NRX 194204 is significantly more selective for the RXRs relative to the RARs (retinoic acid receptors) than a first generation approved drug, it is associated with fewer adverse events in clinical use. This study seeks to investigate NRX 194204 monotherapy in patients with castration- and taxane- resistant prostate cancer.

Inclusion Criteria:

• Histologically or cytologically confirmed prostate cancer
• Documented progression on at least one prior hormone treatment, AND at least one taxane based chemotherapy regimen, or patient's refusal of chemotherapy treatment
• Male, Age > 18 years
• ECOG (Eastern Cooperative Oncology Group) performance score of 0-2
• Adequate bone marrow, renal and hepatic function
• Men of childbearing potential must consent to use barrier contraception while on treatment and for 90 days thereafter

Exclusion Criteria:

• Prior treatment with NRX 194204 or bexarotene (Targretin)
• Presence of parenchymal brain metastases
• History of prior malignancy within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder or other stage I or stage II cancer in complete remission for at least 12 months
• Patients with a history of unstable or newly diagnosed angina pectoris, documented history of current serious arrhythmia or congestive heart failure or myocardial infarction within 6 months of enrollment
• Known HIV or hepatitis B or C infection
• Life expectancy < 3 months
• Patients with any history of thyroid disease, pituitary disease or treatment with thyroid replacement hormone
• Patients with a history of pancreatitis or at significant risk of developing pancreatitis