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

Castration Resistant Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540071
• Other study ID #: 4204-202-2011
• Status: Completed
• Phase: Phase 2
• Start date: August 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2021
• Source: Io Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Castration Resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Lalita Pandit, MD	Fountain Valley	California

Sponsors (1)

Lead Sponsor	Collaborator
Io Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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