A Phase II Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
18 Years
N/A
Male
Castration Resistant Prostate Cancer
Trial Information
A Phase II Trial of NRX 194204 in Castration- 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. Because NRX 194204 is significantly more selective for the RXRs relative to the
RARs 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- resitant prostate cancer.
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 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical benefit of NRX 194204 in men with castration- and taxane-resistant metastatic prostate cancer
Outcome Description:
Clinical benefit will be defined as either non-progression at 8 weeks or radiologic and/or PSA response at any time point with no DLT or other toxicity requiring termination of treatment.
Outcome Time Frame:
participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
Safety Issue:
No
Principal Investigator
Lalita Pandit, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Lalita Pandit, MD
Authority:
United States: Food and Drug Administration
Study ID:
4202-202-2011
NCT ID:
NCT01540071
Start Date:
August 2011
Completion Date:
December 2013
Related Keywords:
- Castration Resistant Prostate Cancer
- Hormone refractory prostate cancer
- HRPC
- Androgen independent prostate cancer
- CRPC
- Castration and Taxane Resistant Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Lalita Pandit, MD | Fountain Valley, California 92708 |
