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CC-115 for Prostate Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about the side effects that patients have when you take the two drugs enzalutamide and CC-115 together.

We also want to learn whether these drugs will work as a treatment for prostate cancer.

What is the Condition Being Studied?

Advanced Prostate Cancer

Who Can Participate in the Study?

Adult patients with advanced prostate cancer that has spread beyond the prostate and has gotten worse after treatment with hormones (ADT).

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Have a screening period that includes a physical exam, collection of demographic data, imaging scans, a tumor biopsy and blood draws.

Once you have completed the screening period, you will:
- Take the study drug CC-115 with standard-of care-enzalutamide that will be taken by mouth at home
- Be asked to return to clinic weekly for the first 4 weeks, then every 8 weeks.
-- At these visits, you will get a medical exam, answer questions about any medications or adverse events, have routine blood tests
- Have imaging scans about every 2 months for the first 6 months and every 3 months after that.

Study Details

Full Title
A Phase 1b Study of Enzalutamide plus CC-115 in Men with Castration-Resistant Prostate Cancer (CRPC)
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00084900
NCT:NCT02833883
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698