Clinical trial · Interventional
Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
A Phase II Trial of NRX 194204 in Castration- and Taxane-Resistant Prostate Cancer
NCT01540071CI-TRIAL-00051821completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration Resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NRX 194204 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NRX 194204
- 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.
- interventionNames
- Drug: NRX 194204
Primary outcomes (1)
- measure
- Clinical Benefit of NRX 194204 in Men With Castration- and Taxane-resistant Metastatic Prostate Cancer
- timeFrame
- participants will be followed for the duration of treatment and follow up, which is up to 2.5 years
- 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.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.