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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NRX 194204 | Drug | NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lalita Pandit, MD | Lalita Pandit, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lalita Pandit, MD | Fountain Valley | California | 92708 | United States |
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A total of 38 patients were recruited
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| ID | Title | Description |
|---|---|---|
| FG000 | NRX 194204 | NRX 194204 capsules, 20 mg PO once per day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NRX 194204 | NRX 194204, 20 mg orally once per day |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | participants will be followed for the duration of treatment and follow up, which is up to 2.5 years |
|
Adverse events were collected as long as each individual patient was receiving study drug, and were further followed for each individual patient for up to a maximum of 2.5 years, or until they were lost to follow-up, or died.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. NRX 194204: NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated PT | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martin E. Sanders, M.D. | Io Therapeutics, Inc. | (650) 219-5973 | msanders@io-therapeutics.com |
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| ID | Term |
|---|---|
| C430898 | AGN 194204 |
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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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 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] | Posted | Mean | Full Range | days | 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. | Posted | Mean | Full Range | days | participants were to be followed for the duration of treatment and follow up; for up to 2.5 years from baseline |
|
|
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| 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 | Posted | Number | events | participants will be followed for the duration of treatment and follow up, which is up to 2.5 years |
|
|
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| Secondary | PSA Response Rate | Prostate specific Antigen (PSA) response rate based on 50% reduction from baseline PSA | Posted | Number | participants | participants will be followed for the duration of treatment and follow up, which is up to 2.5 years |
|
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|
| 0 |
| 38 |
| 13 |
| 38 |
| 38 |
| 38 |
| Elevated INR | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Elevated PTT | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Deep Vein Thrombosis | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Confusion | Nervous system disorders | Non-systematic Assessment |
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| Hallucinations | Nervous system disorders | Non-systematic Assessment |
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| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Probable Upper Gastrointestinal Bleed | Gastrointestinal disorders | Non-systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Rectal Bleeding | Renal and urinary disorders | Non-systematic Assessment |
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| Chest Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | Non-systematic Assessment |
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| Viral Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
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| Enterococcus Bacteremia | Infections and infestations | Non-systematic Assessment |
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| Hypertriglyceridemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Fatigue | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Leucocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
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| Increase Alkaline Phosphatase | Hepatobiliary disorders | Non-systematic Assessment |
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| Hypercholesterolemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Measurements |
|---|
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