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

Io Therapeutics

Status and phase: Completed; Phase 2

Conditions: Castration Resistant Prostate Cancer

Treatments: Drug: NRX 194204

Study type: Interventional

Funder types: Industry

Identifiers

NCT01540071

4204-202-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

NRX 194204

Experimental group

Description:

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.

Treatment:

Drug: NRX 194204