Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03706365
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 18, 2018
First Posted Date  ICMJE October 16, 2018
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE November 27, 2018
Estimated Primary Completion Date September 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • Radiographic Progression Free Survival (rPFS) [ Time Frame: Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months) ]
    rPFS
  • Time to Prostate-Specific Antigen (PSA) Progression [ Time Frame: Baseline to the Date of the First Observation of PSA Progression (Estimated up to 21 Months) ]
    Time to PSA progression
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03706365 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • 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) ]
    ORR: Percentage of participants with a CR or PR
  • 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) ]
    DOR
  • Overall Survival (OS) [ Time Frame: Baseline to Date of Death Due to Any Cause (Estimated up to 40 Months) ]
    OS
  • Time to Symptomatic Progression [ Time Frame: Baseline to the Date of the First Documented Symptomatic Progression (Estimated up to 21 Months) ]
    Time to symptomatic progression
  • Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib [ Time Frame: Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles) ]
    PK: Mean steady state exposure of abemaciclib
  • 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) ]
    PK: Mean steady state exposure of abemaciclib metabolite LSN2839567
  • 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) ]
    PK: Mean steady state exposure of abemaciclib metabolite LSN3106726
  • PK: Mean Steady State Exposure of Abiraterone Acetate [ Time Frame: Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles) ]
    PK: Mean Steady State Exposure of Abiraterone Acetate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Abemaciclib
    Administered orally.
    Other Name: LY2835219
  • Drug: Abiraterone Acetate
    Administered orally.
  • Drug: Prednisone
    Administered orally.
  • Drug: Placebo
    Administered orally.
Study Arms  ICMJE
  • Experimental: A1. Abiraterone plus Prednisone and Abemaciclib
    Abiraterone plus prednisone administered orally and abemaciclib administered orally.
    Interventions:
    • Drug: Abemaciclib
    • Drug: Abiraterone Acetate
    • Drug: Prednisone
  • Experimental: A2. Abiraterone plus Prednisone and Abemaciclib
    Abiraterone plus prednisone administered orally and abemaciclib administered orally.
    Interventions:
    • Drug: Abemaciclib
    • Drug: Abiraterone Acetate
    • Drug: Prednisone
  • Active Comparator: B1. Abiraterone plus Prednisone and Placebo
    Abiraterone plus prednisone administered orally and placebo administered orally.
    Interventions:
    • Drug: Abiraterone Acetate
    • Drug: Prednisone
    • Drug: Placebo
  • Active Comparator: B2. Abiraterone plus Prednisone and Placebo
    Abiraterone plus prednisone administered orally and placebo administered orally.
    Interventions:
    • Drug: Abiraterone Acetate
    • Drug: Prednisone
    • Drug: Placebo
  • Experimental: A. Abiraterone plus Prednisone and Abemaciclib
    Abiraterone plus prednisone administered orally and abemaciclib administered orally.
    Interventions:
    • Drug: Abemaciclib
    • Drug: Abiraterone Acetate
    • Drug: Prednisone
  • Active Comparator: B. Abiraterone plus Prednisone and Placebo
    Abiraterone plus prednisone administered orally and placebo administered orally.
    Interventions:
    • Drug: Abiraterone Acetate
    • Drug: Prednisone
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 11, 2018)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 14, 2024
Estimated Primary Completion Date September 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com
Listed Location Countries  ICMJE Australia,   Denmark,   Germany,   Korea, Republic of,   Netherlands,   Puerto Rico,   Romania,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03706365
Other Study ID Numbers  ICMJE 16598
I3Y-MC-JPCM ( Other Identifier: Eli Lilly and Company )
2016-004276-21 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.clinicalstudydatarequest.com
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP