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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
  Purpose

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.


Condition Intervention Phase
Castration Resistant Prostate Cancer
Drug: NRX 194204
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Io Therapeutics:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 37
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NRX 194204 Drug: NRX 194204
NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day
Other Name: Rexinoid

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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540071

Contacts
Contact: For an updated listing of recruitment sites contact clinicaltrials@io-therapeutics.com

Locations
United States, California
Lalita Pandit, MD Recruiting
Fountain Valley, California, United States, 92708
Contact: Kelly Nelson    714-432-9200    kelly19nelson@sbcglobal.net   
Sponsors and Collaborators
Io Therapeutics
Investigators
Principal Investigator: Lalita Pandit, MD Lalita Pandit, MD
  More Information

No publications provided

Responsible Party: Io Therapeutics
ClinicalTrials.gov Identifier: NCT01540071     History of Changes
Other Study ID Numbers: 4202-202-2011
Study First Received: November 13, 2011
Last Updated: February 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Io Therapeutics:
Hormone refractory prostate cancer
HRPC
Androgen independent prostate cancer
CRPC
Castration and Taxane Resistant Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Taxane
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014