Phase 2
N=38
Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
Castration Resistant Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01540071 ↗Enrolled (actual)
38
Serious AEs
34.2%
Results posted
May 2021
Primary outcome: Primary: Clinical Benefit of NRX 194204 in Men With Castration- and Taxane-resistant Metastatic Prostate Cancer — 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NRX 194204 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Io Therapeutics
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Benefit of NRX 194204 in Men With Castration- and Taxane-resistant Metastatic Prostate Cancer |
19 | — |
| SECONDARY Overall Survival |
312 | — |
| SECONDARY Time to Disease Progression |
105 | — |
| SECONDARY Number of Grade 3 and Higher Adverse Events Deemed at Least Possibly Related to NRX 194204 |
23 | — |
| SECONDARY PSA Response Rate |
1; 6; 29 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01540071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.