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.

Study Overview

• Status: Completed
• Conditions: Castration Resistant Prostate Cancer
• Intervention / Treatment: Drug: NRX 194204

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Lalita Pandit, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NRX 194204; This was a single arm open-label study. All patients enrolled received 20 mg of IRX4204 per day orally, for six months, or longer if the patient had disease stabilization and was tolerating the experimental treatment.	Drug: NRX 194204; NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day; Other Names: Rexinoid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Benefit of NRX 194204 in Men With Castration- and Taxane-resistant Metastatic Prostate Cancer	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.	participants will be followed for the duration of treatment and follow up, which is up to 2.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall Survival [Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years]	participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
Time to Disease Progression	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.	participants were to be followed for the duration of treatment and follow up; for up to 2.5 years from baseline
Number of Grade 3 and Higher Adverse Events Deemed at Least Possibly Related to NRX 194204	Number of Grade 3 and higher Adverse Events deemed at least possibly related to NRX 194204	participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
PSA Response Rate	Prostate specific Antigen (PSA) response rate based on 50% reduction from baseline PSA	participants will be followed for the duration of treatment and follow up, which is up to 2.5 years

Collaborators and Investigators

• Sponsor: Io Therapeutics
• Investigators: Principal Investigator: Lalita Pandit, MD, Lalita Pandit, MD

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 13, 2011
• First Submitted That Met QC Criteria: February 22, 2012
• First Posted (Estimate): February 28, 2012

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: HRPC (Hormone refractory prostate cancer); Androgen independent prostate cancer; CRPC (Castration and Taxane Resistant Prostate Cancer)
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 4204-202-2011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No