Clinical Trials /

Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer

NCT04408924

Description:

The study will evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer
  • Official Title: CYCLONE 1: A Phase 2 Study of Abemaciclib in Metastatic Castration-Resistant Prostate Cancer Patients Previously Treated With a Novel Hormonal Agent and Taxane-based Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: 17583
  • SECONDARY ID: I3Y-MC-JPCY
  • SECONDARY ID: 2020-000290-24
  • NCT ID: NCT04408924

Conditions

  • Metastatic Castration-Resistant Prostate Cancer

Interventions

DrugSynonymsArms
AbemaciclibLY2835219Abemaciclib

Purpose

The study will evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.

Trial Arms

NameTypeDescriptionInterventions
AbemaciclibExperimentalAbemaciclib given orally.
  • Abemaciclib

Eligibility Criteria

        Inclusion Criteria:

          -  Participant must have metastatic prostate cancer for which castration (medical or
             surgical) is no longer effective (castration-resistant).

          -  Participant must have disease spread to soft tissue that is measurable.

          -  Participant must have documented evidence of progressive disease by PSA test or
             imaging.

          -  Participant must have previously received at least one of the following treatment:
             abiraterone acetate, apalutamide, darolutamide or enzalutamide.

          -  Participant must have previously received chemotherapy with docetaxel and cabazitaxel.

          -  Participant must be willing and amenable to undergo a biopsy of tumor tissue (or able
             to provide adequate archived tumor tissue sample) and to provide blood for research.

          -  Participant must have good physical functioning ability and adequate organ function.

        Exclusion Criteria:

          -  Participant must not have received more than 3 therapy regimens for metastatic
             castration-resistant prostate cancer (NOTE: GnRHa, first-generation antiandrogens
             (flutamide, nilutamide, or bicalutamide), diethylstilbestrol (DES) (or other
             estrogens), corticosteroids, ketoconazole, and bone loss-prevention will not count as
             systemic therapy regimens.

          -  Participants must not have previously received abemaciclib or any cyclin-dependent
             kinase (CDK)4 and/or CDK6 inhibitors.

          -  Participants must not have serious and/or uncontrolled preexisting medical
             condition(s) including but not limited to severe renal impairment, severe hepatic
             impairment, interstitial lung disease (ILD)/pneumonitis, severe dyspnea at rest or
             requiring oxygen therapy or other serious preexisting medical condition(s) that, in
             the judgment of the investigator, would preclude participation in this study.

          -  Participants must not have, or suspected to have, brain metastasis.

          -  Participants must not have untreated spinal cord compression, evidence of spinal
             metastases with risk of spinal compression or structurally unstable bone lesions
             suggesting impending fracture.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)
Time Frame:Baseline to Objective Radiographic Soft Tissue Disease Progression (Estimated up to 12 Months)
Safety Issue:
Description:ORR: Percentage of Participants with Best Response of CR or PR

Secondary Outcome Measures

Measure:Radiographic Progression-Free Survival (rPFS)
Time Frame:Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 12 Months)
Safety Issue:
Description:rPFS
Measure:Overall Survival (OS)
Time Frame:Baseline to Date of Death Due to Any Cause (Estimated up to 24 Months)
Safety Issue:
Description:OS
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 12 Months)
Safety Issue:
Description:DoR
Measure:Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR
Time Frame:Baseline to Radiographic Soft Tissue Disease Progression (Estimated up to 12 Months)
Safety Issue:
Description:DCR: Percentage of participants who exhibit SD, CR or PR
Measure:Prostate Specific Antigen (PSA) Response Rate
Time Frame:Baseline to Date of Treatment Discontinuation (Estimated up to 12 Months)
Safety Issue:
Description:PSA Response Rate: Percentage of Participants with a PSA Decrease of at Least 50% from Baseline
Measure:Time to PSA Progression
Time Frame:Baseline to the Date of First Observation of PSA Progression (Estimated up to 12 Months)
Safety Issue:
Description:Time to PSA Progression
Measure:Time to Symptomatic Progression
Time Frame:Baseline to the Date of First Documented Symptomatic Progression (Estimated up to 12 Months)
Safety Issue:
Description:Time to Symptomatic Progression
Measure:Patient-Reported Outcomes (PRO)
Time Frame:Baseline to End of Study (Estimated up to 12 Months)
Safety Issue:
Description:Patient-reported tolerability, including select symptomatic adverse events (from the PRO-Common Terminology Criteria for Adverse Events item library) and overall side-effect burden (item GP5 of the Functional Assessment of Cancer Therapy Tool General form (FACT-G))
Measure:Pharmacokinetics (PK): Mean Steady State Concentration of Abemaciclib and its Metabolites
Time Frame:Predose Cycle 1 Day 15 through Predose Cycle 3 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: Mean Steady State Concentration of Abemaciclib and its Metabolites
Measure:Percentage of Ki-67 Positive Cells by Immunohistochemistry (IHC)
Time Frame:Baseline
Safety Issue:
Description:Percentage of Ki-67 positive cells by IHC

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • mCRPC
  • CDK4
  • CDK6
  • CDK4/6
  • CDK4&6 inhibitor
  • CDK4/6 inhibitor
  • LY2835219
  • CYCLONE 1
  • CYCLONE1

Last Updated

June 2, 2020