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NCT04666129 · ClinicalTrials.gov registry record · Phase 1
Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT04666129: Completed Phase 1 study, sponsored by Sumitomo Pharma America.
NCT04666129 is a Phase 1 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04666129, a Phase 1 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer, either metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic or metastatic castration-resistant prostate cancer (nmCRPC or mCRPC).
Primary Outcome
Parts 1, 2, and 3
Interventions
- DRUG Apalutamide
- DRUG Relugolix
- DRUG Prednisone
- DRUG Abiraterone
- DRUG Methylprednisolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2021-02-18 |
| Est. Completion | 2024-05-28 |
| Phase | Phase 1 |
What the finished NCT04666129 record still lists
NCT04666129 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 5 interventions - of which Apalutamide is the first listed.
NCT04666129 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04666129 about?
NCT04666129 is a clinical study titled "Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer". This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer, either metastatic c...
What is the current status of trial NCT04666129?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2021-02-18. Estimated completion is 2024-05-28.
What interventions are being tested in trial NCT04666129?
The interventions under investigation include: Apalutamide (DRUG), Relugolix (DRUG), Prednisone (DRUG), Abiraterone (DRUG), Methylprednisolone (DRUG).
Who is sponsoring clinical trial NCT04666129?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04666129's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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