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

NCT ID: NCT01540071

Last Updated: 2021-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Castration Resistant Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NRX 194204

Intervention Type: DRUG

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

Interventions

NRX 194204

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

Intervention Type: DRUG

Other Intervention Names

Rexinoid

Eligibility 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 (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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Io Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lalita Pandit, MD

Role: PRINCIPAL_INVESTIGATOR

Lalita Pandit, MD

Locations

Lalita Pandit, MD

Fountain Valley, California, United States

Countries

United States

Other Identifiers

4204-202-2011

Identifier Type: -

Identifier Source: org_study_id