Study on Abiraterone Acetate and Prednisone With or Without Abemaciclib for Prostate Cancer

Sponsor: Eli Lilly and Company

Sponsor score: 60

ClinicalTrials ID:NCT03706365

This clinical trial is testing the safety and effectiveness of adding abemaciclib to the standard treatment of abiraterone acetate and prednisone for men with metastatic castration-resistant prostate cancer. In some cases, prednisolone may be used instead of prednisone.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how safe and effective the drug abemaciclib is when combined with abiraterone acetate and prednisone in treating men with prostate cancer that has spread and is resistant to standard hormone therapy. Prednisolone may be used instead of prednisone depending on local regulations.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of prostate cancer.
  • The cancer has spread to other parts of the body, as shown by bone scans or imaging tests like CT or MRI.
  • The cancer is progressing despite ongoing hormone therapy or after surgical removal of the testicles, shown by:
    • Rising PSA levels
    • Tumor growth seen on scans
  • Have good organ function.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Have previously taken drugs that inhibit CYP17.
  • Have previously been treated with abemaciclib or similar drugs that target CDK 4 & 6.
  • Have received chemotherapy for prostate cancer that is resistant to hormone therapy, except for certain cases.
  • Have had specific treatments like radiopharmaceuticals or certain medications for prostate cancer.
  • Have had radiation or surgery to all cancer sites being measured.
  • Are currently participating in another clinical trial with an investigational drug.
  • Have digestive issues that affect the absorption of medication or difficulty swallowing large pills.
  • Have significant heart disease, active or chronic liver disease, or moderate to severe liver impairment.

Locations

FACILITYZIPCITYSTATE
St. Joseph's Hospital and Medical Center85004PhoenixArizona
Mayo Clinic in Arizona - Phoenix85054PhoenixArizona
The University of Arizona Cancer Center - North Campus85719TucsonArizona
St. Bernards Medical Center72401JonesboroArkansas
CBCC Global Research, Inc.93309BakersfieldCalifornia
Providence St. Jude Medical Center92835FullertonCalifornia
Moores Cancer Center92093La JollaCalifornia
TRIO-US (Translational Research in Oncology-US)90024Los AngelesCalifornia
UCLA Hematology/Oncology - Westwood (Building 100)90095Los AngelesCalifornia
Pacific Cancer Care93940MontereyCalifornia

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