Trials / Completed
CompletedNCT04628988
A Study of CC-90011 and Comparators in Participants With Prostate Cancer
A Phase 1, Open-label, Functional Imaging Study to Assess Whether CC-90011 Reverses the Castration Resistance Due to Lineage Switch in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Have Failed Enzalutamide as Last Prior Therapy, Followed by a Dose Finding Study of CC-90011 Combined With Abiraterone and Prednisone
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Celgene · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CC-90011 | Capsule |
| DRUG | Abiraterone | Tablet |
| DRUG | Prednisone | Tablet |
Timeline
- Start date
- 2021-07-28
- Primary completion
- 2023-05-26
- Completion
- 2023-05-26
- First posted
- 2020-11-16
- Last updated
- 2023-09-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04628988. Inclusion in this directory is not an endorsement.