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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day
Lalita Pandit, MD
Fountain Valley, California, United States
Clinical Benefit of NRX 194204 in Men With Castration- and Taxane-resistant Metastatic Prostate Cancer
Clinical benefit will be defined as either non-progression at 8 weeks or radiologic and/or PSA response at any time point with no dose limiting toxicity (DLT) or other toxicity requiring termination of treatment.
Time frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
Overall Survival
Overall Survival \[Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years\]
Time frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
Time to Disease Progression
Time to Disease Progression was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1. Progression was defined as at least a 20% relative increase and an absolute increase of at least 5mm; or appearance of new lesions.
Time frame: participants were to be followed for the duration of treatment and follow up; for up to 2.5 years from baseline
Number of Grade 3 and Higher Adverse Events Deemed at Least Possibly Related to NRX 194204
Number of Grade 3 and higher Adverse Events deemed at least possibly related to NRX 194204
Time frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
PSA Response Rate
Prostate specific Antigen (PSA) response rate based on 50% reduction from baseline PSA
Time frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
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