A Study of CC-90011 and Comparators in Participants With Prostate Cancer

Phase 1

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 1.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called CC-90011 to see if it can help prostate cancer patients, who no longer respond to usual treatments, by making their cancer cells sensitive again to specific therapies.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Androgen Receptor

Secondary study objectives

Assessment of anti-tumor activity

Safety and tolerability assessed by Adverse events (AEs)

Safety and tolerability assessed by dose-limiting toxicities (DLTs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CC-90011 in combination with Abiraterone and PrednisoneExperimental Treatment3 Interventions

Oral administration (PO) of CC-90011 monotherapy administered once per week (QW), for 4 weeks. From cycle 2 onwards, all participants will receive 60 mg of CC-90011 PO QW, in combination with 100 mg of abiraterone PO daily, and 5 mg of prednisone PO every 12 hours (10mg QD)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CC-90011

2020

Completed Phase 2

~190

Abiraterone

2012

Completed Phase 4

~4480