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A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer (CYCLONE 2)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706365
Recruitment Status : Active, not recruiting
First Posted : October 16, 2018
Last Update Posted : May 23, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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. Prednisolone may be used instead of prednisone per local regulation.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Abemaciclib Drug: Abiraterone Acetate Drug: Prednisone Drug: Placebo Phase 2 Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : November 3, 2023
Estimated Study Completion Date : June 15, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: A1. Abiraterone plus Prednisone and Abemaciclib
Abiraterone plus prednisone administered orally and abemaciclib administered orally.
 Drug: Abemaciclib
Administered orally.
Other Name: LY2835219

Drug: Abiraterone Acetate
Administered orally.

Drug: Prednisone
Administered orally.
Experimental: A2. Abiraterone plus Prednisone and Abemaciclib
Abiraterone plus prednisone administered orally and abemaciclib administered orally.
 Drug: Abemaciclib
Administered orally.
Other Name: LY2835219

Drug: Abiraterone Acetate
Administered orally.

Drug: Prednisone
Administered orally.
Active Comparator: B1. Abiraterone plus Prednisone and Placebo
Abiraterone plus prednisone administered orally and placebo administered orally.
 Drug: Abiraterone Acetate
Administered orally.

Drug: Prednisone
Administered orally.

Drug: Placebo
Administered orally.
Active Comparator: B2. Abiraterone plus Prednisone and Placebo
Abiraterone plus prednisone administered orally and placebo administered orally.
 Drug: Abiraterone Acetate
Administered orally.

Drug: Prednisone
Administered orally.

Drug: Placebo
Administered orally.
Experimental: A. Abiraterone plus Prednisone and Abemaciclib
Abiraterone plus prednisone administered orally and abemaciclib administered orally.
 Drug: Abemaciclib
Administered orally.
Other Name: LY2835219

Drug: Abiraterone Acetate
Administered orally.

Drug: Prednisone
Administered orally.
Active Comparator: B. Abiraterone plus Prednisone and Placebo
Abiraterone plus prednisone administered orally and placebo administered orally.
 Drug: Abiraterone Acetate
Administered orally.

Drug: Prednisone
Administered orally.

Drug: Placebo
Administered orally.


Outcome Measures
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Primary Outcome Measures :
  1. Radiographic Progression Free Survival (rPFS) [ Time Frame: Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months) ]
    rPFS by investigator assessment


Secondary Outcome Measures :
  1. 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

  2. Radiographic Progression Free Survival (rPFS) [ Time Frame: Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months) ]
    rPFS by blinded, independent, central review

  3. 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

  4. 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

  5. Overall Survival (OS) [ Time Frame: Baseline to Date of Death Due to Any Cause (Estimated up to 40 Months) ]
    OS

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Time to Worst Pain Progression [ Time Frame: Baseline through follow-up (Estimated up to 21 months) ]
    Measured by the Worst Pain Numeric Rating Scale (NRS) and World Health Organization-Analgesic Ladder (WHO-AL). NRS score measures worst pain over the last 24 hours on a 0 to 10-point NRS, where 0 -s "no pain" and 10 is "pain as bad as you can imagine. The WHO-AL classifies analgesic use into four categories, where 1 = no analgesic and 4 = strong opioids.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  • 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706365


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03706365    
Other Study ID Numbers: 16598
I3Y-MC-JPCM ( Other Identifier: Eli Lilly and Company )
2016-004276-21 ( EudraCT Number )
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Metastatic Castration Resistant Prostate Cancer
mCRPC
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Prednisone
Abiraterone Acetate
 Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors