or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Castration Resistant Prostate Cancer

Thank you

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