Conditions: Castration Resistant Prostate Cancer
Keywords: HRPC (Hormone refractory prostate cancer) Androgen independent prostate cancer CRPC (Castration and Taxane Resistant Prostate Cancer)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 38
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: This was a single arm open-label study. All patients enrolled received 20 mg of IRX4204 per day orally, for six months, or longer if the patient had disease stabilization and was tolerating the experimental treatment.

Interventions: intervention 1: NRX 194204
Intervention descriptions: intervention 1: NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day

Protocol document: