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NCT Number: NCT01540071

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.

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Key information

Conditions

Castration Resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Lalita Pandit, MD

Fountain Valley, California, 92708, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NRX 194204

Drug

NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day

Other names: Rexinoid

Primary outcomes

  1. 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

    Clinical benefit will be defined as either non-progression at 8 weeks or radiologic and/or PSA response at any time point with no dose limiting toxicity (DLT) or other toxicity requiring termination of treatment.

Secondary outcomes

  1. Overall Survival

    Time frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years

    Overall Survival [Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years]

  2. Time to Disease Progression

    Time frame: participants were to be followed for the duration of treatment and follow up; for up to 2.5 years from baseline

    Time to Disease Progression was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1. Progression was defined as at least a 20% relative increase and an absolute increase of at least 5mm; or appearance of new lesions.

  3. Number of Grade 3 and Higher Adverse Events 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

    Number of Grade 3 and higher Adverse Events deemed at least possibly related to NRX 194204

  4. PSA Response Rate

    Time frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years

    Prostate specific Antigen (PSA) response rate based on 50% reduction from baseline PSA

Sponsors and collaborators

Lead sponsor

Io Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 28, 2012
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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