EICHORCondition: Prostate Cancer Metastatic · Castration-resistant Prostate Cancer · Sponsor: Hinova Pharmaceuticals USA, Inc.
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This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy and safety study of oral HC-1119 (80 mg/day) versus enzalutamide (160 mg/day) in asymptomatic or mildly symptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC). The following assessment of prostate cancer status will be collected during the course of the trial: soft tissue disease on computed tomography (CT) scan or on magnetic resonance imaging (MRI), bone disease on radionuclide bone scans, FACT-P and EQ-5D, Brief Fatigue Inventory, and PSA. Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Blood samples for population pharmacokinetics for HC-1119 and enzalutamide and related metabolites will be collected.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
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| Urology Center of Colorado, 2777 Mile High Stadium Circle | Denver, Colorado, United States | — |
| Urologic Surgeons of Washington | Washington D.C., District of Columbia, United States | — |
| First Urology PSC, 101 Hospital Boulevard | Jeffersonville, Indiana, United States | — |
| Clinical Research Solutions PC | Middleburg Heights, Ohio, United States | — |
| MidLantic Urology | Bala-Cynwyd, Pennsylvania, United States | — |
| Keystone Urology Specialists | Lancaster, Pennsylvania, United States | — |
| Urology San Antonio Stone Oak, 18915 Meisner Drive | San Antonio, Texas, United States | — |
| Providence Regional Cancer System | Lacey, Washington, United States | — |
| Icon Cancer Care Gold Coast | Southport, Queensland, Australia | — |
| Ashford Cancer Centre Research | Kurralta Park, South Australia, Australia | — |
| Affinity Clinical Research | Nedlands, Australia | — |
| Kepler Universitätsklinikum Linz | Linz, Austria | — |
+ 46 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03850795