Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer

Keywords

Prostate Cancer Metastatic Castration Resistant Prostate Cancer mCRPC Prostatic Neoplasms Prednisone Abiraterone Acetate Abemaciclib A1. Abiraterone plus Prednisone and Abemaciclib A2. Abiraterone plus Prednisone and Abemaciclib A. Abiraterone plus Prednisone and Abemaciclib

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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.

You CAN'T join if...

  • 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).

Locations

  • University of California - San Diego accepting new patients
    La Jolla California 92037 United States
  • TRIO - Translational Research in Oncology-US, Inc. accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
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.
ID
NCT03706365
Phase
Phase 2
Study Type
Interventional
Last Updated