Expired Study
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Fountain Valley, California 92708


Purpose:

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.


Study summary:

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. Because NRX 194204 is significantly more selective for the RXRs relative to the RARs 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- resitant prostate cancer.


Criteria:

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 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


NCT ID:

NCT01540071


Primary Contact:

Principal Investigator
Lalita Pandit, MD
Lalita Pandit, MD


Backup Contact:

N/A


Location Contact:

Fountain Valley, California 92708
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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