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NCT05413421 · ClinicalTrials.gov registry record · Phase 1
Study of ORIC-944 in Patients With Metastatic Prostate Cancer
A Phase 1 study of Metastatic Prostate Cancer, sponsored by ORIC Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 250
- Enrollment target
- 20
- Study locations
NCT05413421: Recruiting Phase 1 study of Metastatic Prostate Cancer, sponsored by ORIC Pharmaceuticals.
NCT05413421 is a Phase 1 study of Metastatic Prostate Cancer that is actively recruiting participants, run by ORIC Pharmaceuticals. The registered enrollment target is 250 participants, above the 180-participant average among 41 other Metastatic Prostate Cancer trials with a reported enrollment target (39% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05413421, a Phase 1 study of Metastatic Prostate Cancer, is actively recruiting participants, sponsored by ORIC Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 250 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combinations with ARPIs in patients with metastatic prostate cancer.
Primary Outcome
RP2D as determined by interval 3+3 dose escalation design
Conditions Studied
Interventions
- DRUG ORIC-944
- DRUG Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets
- DRUG Apalutamide (Erleada™) 60 mg or 240 mg tablets
- DRUG Darolutamide (Nubeqa®) 300 mg tablets
- DRUG Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets
Study Locations (20)
Illinois
- Illinois Cancer Specialists - Arlington Heights
- Comprehensive Urologic Care - Lake Barrington
Maryland
- Marlene & Stewart Greenebaum Comprehensive Cancer Center, University of Maryland - Baltimore
- Maryland Oncology Hematology - Silver Spring
Pennsylvania
- MidLantic Urology - Bala-Cynwyd
- Keystone Urology Specialists - Lancaster
Texas
- Amarillo Urology Research - Amarillo
- Urology Clinics of North Texas - Dallas
Virginia
- Virginia Oncology Associates - Fairfax
- Virginia Cancer Specialists - Norfolk
Colorado
- Rocky Mountain Cancer Center - Colorado Springs
Florida
- South Florida Oncology and Hematology - Plantation
Indiana
- First Urology - Jeffersonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2026-09 |
| Phase | Phase 1 |
What NCT05413421 shows while recruiting
NCT05413421 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 180-participant average among 41 other Metastatic Prostate Cancer trials with a reported enrollment target (39% higher).
The record links to 1 condition, with Metastatic Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which ORIC-944 is the first listed.
NCT05413421 names 20 study sites across 15 states, led by Illinois, Maryland, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05413421 about?
NCT05413421 is a clinical study titled "Study of ORIC-944 in Patients With Metastatic Prostate Cancer". The purpose of this study is to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combinations with ARPIs in patients with metastatic prostate cancer.
What is the current status of trial NCT05413421?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 250 participants. The study started on 2022-06-01. Estimated completion is 2026-09.
What conditions does trial NCT05413421 study?
This clinical trial studies the following conditions: Metastatic Prostate Cancer.
What interventions are being tested in trial NCT05413421?
The interventions under investigation include: ORIC-944 (DRUG), Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets (DRUG), Apalutamide (Erleada™) 60 mg or 240 mg tablets (DRUG), Darolutamide (Nubeqa®) 300 mg tablets (DRUG), Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets (DRUG).
Who is sponsoring clinical trial NCT05413421?
This trial is sponsored by ORIC Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05413421 being conducted?
This trial has 20 study locations across Colorado, Florida, Illinois, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05413421's enrollment target sits among peer trials
250 8th of 41 higher than 34 of 41 other Metastatic Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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