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

NCT01540071 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 4204-202-2011
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Castration Resistant Prostate Cancer

Keywords

HRPC (Hormone refractory prostate cancer); Androgen independent prostate cancer; CRPC (Castration and Taxane Resistant Prostate Cancer)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall Survival

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

• Time to Disease Progression

  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

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

• PSA Response Rate

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

Study Arms (1)

NRX 194204

EXPERIMENTAL

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

Interventions

NRX 194204 DRUG

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

Also known as: Rexinoid

NRX 194204

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Io Therapeutics: lead

Study Sites (1)

Lalita Pandit, MD

Fountain Valley, California, 92708, United States

Location

MeSH Terms

Interventions

AGN 194204

Results Point of Contact

• Title: Martin E. Sanders, M.D.
• Organization: Io Therapeutics, Inc.

msanders@io-therapeutics.com

(650) 219-5973

Study Officials

• Lalita Pandit, MD

  Lalita Pandit, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2011
• First Posted: February 28, 2012
• Study Start: August 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 14, 2021
• Results First Posted: May 14, 2021

Record last verified: 2021-04

Locations

US (1)