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NCT04628988 · ClinicalTrials.gov registry record · Phase 1
A Study of CC-90011 and Comparators in Participants With Prostate Cancer
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04628988: Completed Phase 1 study, sponsored by Celgene.
NCT04628988 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04628988, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is an open-label, positron emission tomography (PET) imaging Proof of Biology (POB) study to determine whether CC -90011 reverses, by the induction of androgen receptor (AR) expression, the castration resistance, due to lineage switch, in participants with mCRPC that have failed enzalutamide as last prior therapy. This study aims to assess whether CC-90011 can induce AR expression and, consequently, re-sensitize tumors to anti-hormonal therapy.
Primary Outcome
FDG/FDHT PET imaging will be compared with Screening to Cycle 1 (each cycle is 28 days) and from Cycle 1 to Cycle 3 (Cycle 2-3 is combined therapy period) to assess changes in AR expression.
Interventions
- DRUG Prednisone
- DRUG Abiraterone
- DRUG CC-90011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-07-28 |
| Est. Completion | 2023-05-26 |
| Phase | Phase 1 |
What the finished NCT04628988 record still lists
NCT04628988 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT04628988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04628988 about?
NCT04628988 is a clinical study titled "A Study of CC-90011 and Comparators in Participants With Prostate Cancer". This is an open-label, positron emission tomography (PET) imaging Proof of Biology (POB) study to determine whether CC -90011 reverses, by the induction of androgen receptor (AR) expression, the castration resistance, due to lineage switch, in participants with mCRPC that have failed enzalutamide as...
What is the current status of trial NCT04628988?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2021-07-28. Estimated completion is 2023-05-26.
What interventions are being tested in trial NCT04628988?
The interventions under investigation include: Prednisone (DRUG), Abiraterone (DRUG), CC-90011 (DRUG).
Who is sponsoring clinical trial NCT04628988?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04628988's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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