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NCT04033328 · ClinicalTrials.gov registry record · Phase 1
Study of ORIC-101 in Combination With Enzalutamide
A Phase 1 study, sponsored by ORIC Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT04033328: Clinical Trial Phase 1 study, sponsored by ORIC Pharmaceuticals.
NCT04033328 is a Phase 1 study that was terminated before completion, run by ORIC Pharmaceuticals. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04033328, a Phase 1 study, was terminated before completion, sponsored by ORIC Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-101 in combination with enzalutamide (Xtandi®) when administered to patients with metastatic prostate cancer progressing on enzalutamide.
Primary Outcome
RP2D as determined by 3+3 dose escalation design
Interventions
- DRUG ORIC-101
- DRUG enzalutamide 40 MG oral capsule [Xtandi]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2019-10-28 |
| Est. Completion | 2023-12-04 |
| Phase | Phase 1 |
Why NCT04033328 stopped before completion
NCT04033328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which ORIC-101 is the first listed.
NCT04033328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04033328 about?
NCT04033328 is a clinical study titled "Study of ORIC-101 in Combination With Enzalutamide". The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-101 in combination with enzalutamide (Xtandi®) when administered to patients with metastatic prostate cancer progressing on ...
What is the current status of trial NCT04033328?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2019-10-28. Estimated completion is 2023-12-04.
What interventions are being tested in trial NCT04033328?
The interventions under investigation include: ORIC-101 (DRUG), enzalutamide 40 MG oral capsule [Xtandi] (DRUG).
Who is sponsoring clinical trial NCT04033328?
This trial is sponsored by ORIC Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04033328's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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