Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Androgens

Hormones

Taxane

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.

NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day

NRX 194204

Lalita Pandit, MD

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.

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

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.

Overall Survival \[Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years\]

Time to Disease Progression 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.

Number of Grade 3 and higher Adverse Events deemed at least possibly related to NRX 194204

Prostate specific Antigen (PSA) response rate based on 50% reduction from baseline PSA

Io Therapeutics

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.

NRX 194204: NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Martin E. Sanders, M.D.

Clinical Benefit of NRX 194204 in Men With Castration- and Taxane-resistant Metastatic Prostate Cancer

This was a single arm open-label study. All patients enrolled and treated 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.

Spots Global Cancer Trial Database for crpc (castration and taxane resistant prostate cancer)