Back to resultsTrial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
Primary Purpose
Castration Resistant Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NRX 194204
Sponsored by
About this trial
This is an interventional treatment trial for Castration Resistant Prostate Cancer focused on measuring HRPC (Hormone refractory prostate cancer), Androgen independent prostate cancer, CRPC (Castration and Taxane Resistant Prostate Cancer)
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
Sites / Locations
- Lalita Pandit, MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NRX 194204
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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]
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.
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
PSA Response Rate
Prostate specific Antigen (PSA) response rate based on 50% reduction from baseline PSA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01540071
Brief Title
Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
Official Title
A Phase II Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Io Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration Resistant Prostate Cancer
Keywords
HRPC (Hormone refractory prostate cancer), Androgen independent prostate cancer, CRPC (Castration and Taxane Resistant Prostate Cancer)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NRX 194204
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
NRX 194204
Other Intervention Name(s)
Rexinoid
Intervention Description
NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day
Primary Outcome Measure Information:
Title
Clinical Benefit of NRX 194204 in Men With Castration- and Taxane-resistant Metastatic Prostate Cancer
Description
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.
Time Frame
participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival [Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years]
Time Frame
participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
Title
Time to Disease Progression
Description
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.
Time Frame
participants were to be followed for the duration of treatment and follow up; for up to 2.5 years from baseline
Title
Number of Grade 3 and Higher Adverse Events Deemed at Least Possibly Related to NRX 194204
Description
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
Title
PSA Response Rate
Description
Prostate specific Antigen (PSA) response rate based on 50% reduction from baseline PSA
Time Frame
participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lalita Pandit, MD
Organizational Affiliation
Lalita Pandit, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lalita Pandit, MD
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
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