A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Feb 14, 2024
  • participants needed
    180
  • sponsor
    Eli Lilly and Company
Updated on 26 November 2020
Investigator
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Primary Contact
Macquarie University Hospital (1.3 mi away) Contact
+122 other location
prednisone
androgens
progressive disease
bone scan
abiraterone
metastatic prostate cancer
orchiectomy
adenocarcinoma
adenocarcinoma of prostate
prostate cancer metastatic

Summary

This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.

Details
Treatment prednisone, Placebo, abiraterone acetate, Abemaciclib
Clinical Study IdentifierNCT03706365
SponsorEli Lilly and Company
Last Modified on26 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have any of these conditions: Prostate Cancer or Prostate Disorders or Prostatic disorder or Prostate Cancer, Early, Recurrent or Malignant neoplasm of prostate?
Do you have any of these conditions: Prostate Disorders or Prostatic disorder or Prostate Cancer or Malignant neoplasm of prostate or Prostate Cancer, Early, Recurrent or prostate carcino...?
Histologically confirmed adenocarcinoma of the prostate
Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or magnetic resonance imaging (MRI)
Progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy defined as one or more of the following
PSA progression
Radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3) for bone, with or without PSA progression
Be able and willing to undergo mandatory tumor biopsy of at least one metastatic site
Have adequate organ function
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Exclusion Criteria

Prior therapy with cytochrome P450 (CYP)17 inhibitors
Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 & 6 inhibitors
Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (participants treated with docetaxel in the metastatic hormone-sensitive prostate cancer [mHSPC] are eligible), prior radiopharmaceuticals for prostate cancer, or prior enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who had prior radiation or surgery to all target lesions
Currently enrolled in a clinical study involving an investigational product
Gastrointestinal disorder affecting the absorption or ability to swallow large pills
Clinically significant heart disease, active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh Class B and C)
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