Trial Outcomes & Findings for Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer (NCT NCT01540071)

Last Updated: 2021-05-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

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

Results posted on

2021-05-14

Participant Flow

A total of 38 patients were recruited

Participant milestones

Participant milestones
Measure	NRX 194204 NRX 194204 capsules, 20 mg PO once per day
Overall Study STARTED	38
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NRX 194204 n=38 Participants NRX 194204, 20 mg orally once per day
Age, Continuous	71.6 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	NRX 194204 n=38 Participants 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
Clinical Benefit of NRX 194204 in Men With Castration- and Taxane-resistant Metastatic Prostate Cancer	19 Participants

SECONDARY outcome

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

Overall Survival \[Time Frame: participants will be followed for the duration of treatment and follow up, which is up to 2.5 years\]

Outcome measures

Outcome measures
Measure	NRX 194204 n=38 Participants 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
Overall Survival	312 days Interval 38.0 to 933.0

SECONDARY outcome

Timeframe: participants were to be followed for the duration of treatment and follow up; for up to 2.5 years from baseline

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.

Outcome measures

Outcome measures
Measure	NRX 194204 n=36 Participants 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
Time to Disease Progression	105 days Interval 21.0 to 540.0

SECONDARY outcome

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

Number of Grade 3 and higher Adverse Events deemed at least possibly related to NRX 194204

Outcome measures

Outcome measures
Measure	NRX 194204 n=38 Participants 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
Number of Grade 3 and Higher Adverse Events Deemed at Least Possibly Related to NRX 194204	23 events

SECONDARY outcome

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

Prostate specific Antigen (PSA) response rate based on 50% reduction from baseline PSA

Outcome measures

Outcome measures
Measure	NRX 194204 n=36 Participants 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
PSA Response Rate partial response	1 participants
PSA Response Rate stable disease	6 participants
PSA Response Rate progressive disease	29 participants

Adverse Events

NRX 194204

Serious events: 13 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NRX 194204 n=38 participants at risk 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
Blood and lymphatic system disorders Elevated PT	2.6% 1/38 • Number of events 1 • 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.
Blood and lymphatic system disorders Elevated INR	2.6% 1/38 • Number of events 1 • 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.
Blood and lymphatic system disorders Elevated PTT	2.6% 1/38 • Number of events 1 • 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.
Blood and lymphatic system disorders Deep Vein Thrombosis	2.6% 1/38 • Number of events 1 • 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.
Nervous system disorders Confusion	5.3% 2/38 • Number of events 2 • 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.
Nervous system disorders Hallucinations	2.6% 1/38 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	5.3% 2/38 • Number of events 2 • 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.
Gastrointestinal disorders Probable Upper Gastrointestinal Bleed	2.6% 1/38 • Number of events 1 • 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.
Renal and urinary disorders Urinary Tract Infection	2.6% 1/38 • Number of events 2 • 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.
Blood and lymphatic system disorders Anemia	5.3% 2/38 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.6% 1/38 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.3% 2/38 • Number of events 2 • 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.
Renal and urinary disorders Rectal Bleeding	2.6% 1/38 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Chest Pain	2.6% 1/38 • Number of events 1 • 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.
Metabolism and nutrition disorders Dehydration	5.3% 2/38 • Number of events 2 • 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.
Cardiac disorders Congestive Heart Failure	5.3% 2/38 • Number of events 2 • 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.
Gastrointestinal disorders Viral Gastroenteritis	2.6% 1/38 • Number of events 1 • 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.
Infections and infestations Enterococcus Bacteremia	2.6% 1/38 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	NRX 194204 n=38 participants at risk 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
Endocrine disorders Hypothyroidism	31.6% 12/38 • Number of events 12 • 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.
Metabolism and nutrition disorders Hypertriglyceridemia	39.5% 15/38 • Number of events 15 • 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.
Metabolism and nutrition disorders Fatigue	34.2% 13/38 • Number of events 13 • 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.
Metabolism and nutrition disorders Anorexia	13.2% 5/38 • Number of events 5 • 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.
Metabolism and nutrition disorders Dehydration	5.3% 2/38 • Number of events 2 • 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.
Gastrointestinal disorders Vomiting	7.9% 3/38 • Number of events 3 • 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.
Blood and lymphatic system disorders Anemia	15.8% 6/38 • Number of events 6 • 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.
Blood and lymphatic system disorders Leucocytopenia	15.8% 6/38 • Number of events 6 • 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.
Renal and urinary disorders Urinary Tract Infection	5.3% 2/38 • Number of events 2 • 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.
Hepatobiliary disorders Increase Alkaline Phosphatase	5.3% 2/38 • Number of events 2 • 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.
Metabolism and nutrition disorders Hypercholesterolemia	13.2% 5/38 • Number of events 5 • 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.
Musculoskeletal and connective tissue disorders Back Pain	10.5% 4/38 • Number of events 4 • 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.
Gastrointestinal disorders Nausea	7.9% 3/38 • Number of events 3 • 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.

Additional Information

Martin E. Sanders, M.D.

Io Therapeutics, Inc.

Phone: (650) 219-5973

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place