Clinical Trials /

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

NCT03706365

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 16598
  • SECONDARY ID: I3Y-MC-JPCM
  • SECONDARY ID: 2016-004276-21
  • NCT ID: NCT03706365

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
AbemaciclibLY2835219A1. Abiraterone plus Prednisone and Abemaciclib
Abiraterone AcetateA1. Abiraterone plus Prednisone and Abemaciclib
PrednisoneA1. Abiraterone plus Prednisone and Abemaciclib
PlaceboB1. Abiraterone plus Prednisone and Placebo

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
A1. Abiraterone plus Prednisone and AbemaciclibExperimentalAbiraterone plus prednisone administered orally and abemaciclib administered orally.
  • Abemaciclib
  • Abiraterone Acetate
  • Prednisone
A2. Abiraterone plus Prednisone and AbemaciclibExperimentalAbiraterone plus prednisone administered orally and abemaciclib administered orally.
  • Abemaciclib
  • Abiraterone Acetate
  • Prednisone
B1. Abiraterone plus Prednisone and PlaceboActive ComparatorAbiraterone plus prednisone administered orally and placebo administered orally.
  • Abiraterone Acetate
  • Prednisone
  • Placebo
B2. Abiraterone plus Prednisone and PlaceboActive ComparatorAbiraterone plus prednisone administered orally and placebo administered orally.
  • Abiraterone Acetate
  • Prednisone
  • Placebo
A. Abiraterone plus Prednisone and AbemaciclibExperimentalAbiraterone plus prednisone administered orally and abemaciclib administered orally.
  • Abemaciclib
  • Abiraterone Acetate
  • Prednisone
B. Abiraterone plus Prednisone and PlaceboActive ComparatorAbiraterone plus prednisone administered orally and placebo administered orally.
  • Abiraterone Acetate
  • Prednisone
  • Placebo

Eligibility Criteria

        Inclusion Criteria:

          -  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, 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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Radiographic Progression Free Survival (rPFS)
Time Frame:Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)
Safety Issue:
Description:rPFS

Secondary Outcome Measures

Measure:Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)
Time Frame:Baseline to Radiographic Disease Progression (Estimated up to 21 Months)
Safety Issue:
Description:ORR: Percentage of participants with a CR or PR
Measure:Duration of Response (DOR)
Time Frame:Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)
Safety Issue:
Description:DOR
Measure:Overall Survival (OS)
Time Frame:Baseline to Date of Death Due to Any Cause (Estimated up to 40 Months)
Safety Issue:
Description:OS
Measure:Time to Symptomatic Progression
Time Frame:Baseline to the Date of the First Documented Symptomatic Progression (Estimated up to 21 Months)
Safety Issue:
Description:Time to symptomatic progression
Measure:Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
Time Frame:Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: Mean steady state exposure of abemaciclib
Measure:PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
Time Frame:Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: Mean steady state exposure of abemaciclib metabolite LSN2839567
Measure:PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
Time Frame:Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: Mean steady state exposure of abemaciclib metabolite LSN3106726
Measure:PK: Mean Steady State Exposure of Abiraterone Acetate
Time Frame:Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: Mean Steady State Exposure of Abiraterone Acetate

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • Metastatic Castration Resistant Prostate Cancer
  • mCRPC

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