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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Io Therapeutics.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Io Therapeutics
ClinicalTrials.gov Identifier:
NCT01540071
First received: November 13, 2011
Last updated: February 22, 2012
Last verified: February 2012

November 13, 2011
February 22, 2012
August 2011
December 2013   (final data collection date for primary outcome measure)
Clinical benefit of NRX 194204 in men with castration- and taxane-resistant metastatic prostate cancer [ Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01540071 on ClinicalTrials.gov Archive Site
  • overall survival [ Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years ] [ Designated as safety issue: No ]
  • time to radiologic progression [ Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years ] [ Designated as safety issue: No ]
  • RECIST response rate for patients with measurable disease [ Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years ] [ Designated as safety issue: No ]
    RECIST 1.1 will be used
  • Number of Grade 3 and higher AEs deemed at least possibly related to NRX 194204 [ Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years ] [ Designated as safety issue: Yes ]
  • PSA response rate [ Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years ] [ Designated as safety issue: No ]
  • pain palliation [ Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years ] [ Designated as safety issue: No ]
    Questionnaire based on the SWOG symptom questionnaire will be used.
Same as current
Not Provided
Not Provided
 
Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
A Phase II Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Castration Resistant Prostate Cancer
Drug: NRX 194204
NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day
Other Name: Rexinoid
Experimental: NRX 194204
Intervention: Drug: NRX 194204
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
37
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: For an updated listing of recruitment sites contact clinicaltrials@io-therapeutics.com
United States
 
NCT01540071
4202-202-2011
Yes
Io Therapeutics
Io Therapeutics
Not Provided
Principal Investigator: Lalita Pandit, MD Lalita Pandit, MD
Io Therapeutics
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP