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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
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
~4570
Prednisone
2014
Completed Phase 4
~2500
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Who is running the clinical trial?
CelgeneLead Sponsor
645 Previous Clinical Trials
130,434 Total Patients Enrolled
5 Trials studying Prostate Cancer
1,270 Patients Enrolled for Prostate Cancer
Zariana Nikolova, MD, PhDStudy DirectorCelgene
5 Previous Clinical Trials
493 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,568 Previous Clinical Trials
3,384,329 Total Patients Enrolled
13 Trials studying Prostate Cancer
3,967 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: CC-90011 in combination with Abiraterone and Prednisone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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