Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
Completed · Phase 2
Conditions studied: Castration Resistant Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT01540071
- Run by
- Io Therapeutics
- People needed
- 38
- Starts
- 2011-08-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2021-05-14
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Lalita Pandit, MD — Fountain Valley, California, United States
Full record on ClinicalTrials.gov
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