Clinical trial NCT01540071: Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
Official title: A Phase II Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Castration Resistant Prostate Cancer
Keywords: HRPC (Hormone refractory prostate cancer)
Androgen independent prostate cancer
CRPC (Castration and Taxane Resistant Prostate Cancer)
Lead sponsor: Io Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-02-28
Enrollment: 38
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Clinical Benefit of NRX 194204 in Men With Castration- and Taxane-resistant Metastatic Prostate Cancer
timeFrame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
Secondary outcomes:
measure: Overall Survival
timeFrame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
measure: Time to Disease Progression
timeFrame: participants were to be followed for the duration of treatment and follow up; for up to 2.5 years from baseline
measure: Number of Grade 3 and Higher Adverse Events Deemed at Least Possibly Related to NRX 194204
timeFrame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
measure: PSA Response Rate
timeFrame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Lalita Pandit, MD
state: California
Study officials:
affiliation: Lalita Pandit, MD
name: Lalita Pandit, MD
role: PRINCIPAL_INVESTIGATOR
References: