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Trial record 24 of 68 for:    prostate cancer | Recruiting Studies | ( Map: Florida, United States )

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

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ClinicalTrials.gov Identifier: NCT03706365
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : February 14, 2024

Resource links provided by the National Library of Medicine


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.




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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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



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
  • 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).

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


Contacts
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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

  Show 67 Study Locations
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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03706365     History of Changes
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: March 19, 2019
Last Verified: March 2019
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: http://www.clinicalstudydatarequest.com

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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
Prostatic Diseases
Genital Diseases, Male
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