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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Io Therapeutics
• Treatments: Taxane

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 (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