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Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment

Primary Purpose

Prostatic Neoplasms

Status
Not yet recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Abemaciclib
Darolutamide
LHRH agonist/antagonist
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate. Metastatic castration-resistant prostate cancer evidenced by: Prostate-specific antigen (PSA) or radiographic progression despite castrate levels of testosterone At least 1 bone metastasis on bone scan and/or 1 soft tissue metastasis on computed tomography/magnetic resonance imaging (CT/MRI) Participants who have not undergone bilateral orchiectomy must continue luteinizing-hormone-releasing hormone (LHRH) agonists/antagonists throughout the study. Have adequate organ function. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Exclusion Criteria: Prior treatment with cyclin-dependent kinase 4 and 6 (CDK4 and CDK6) inhibitors or darolutamide. Prior systemic therapy for metastatic castration-resistant prostate cancer(mCRPC) with cytotoxic chemotherapy, PARP inhibitors, novel hormonal agents (NHAs) (enzalutamide, apalutamide, and abiraterone), and radiopharmaceuticals. Serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study. Clinically significant heart disease as evidenced by myocardial infarction, arterial thrombotic events, severe or unstable angina, or congestive heart failure (New York Heart Association Class III or IV) within 6 months of assignment to treatment.

Sites / Locations

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island
  • Laura and Isaac Perlmutter Cancer Center
  • Studienpraxis Urologie
  • Universitaetsklinikum Hamburg-Eppendorf
  • Instituto Catalan de Oncologia - Hospital Duran i Reynals
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario 12 de Octubre
  • Hospital Infanta Cristina
  • Hospital Universitario Virgen Del Rocio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abemaciclib + Darolutamide

Arm Description

Abemaciclib plus (+) darolutamide. Participants who have not undergone bilateral orchiectomy are required to continue background androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist/antagonist throughout the study.

Outcomes

Primary Outcome Measures

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Administration Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration

Secondary Outcome Measures

Radiographic Progression-Free Survival (rPFS) Assessed by Investigator rPFS Assessed by Investigator
rPFS Assessed by Investigator
Objective Response Rate (ORR): Percentage of Participants with Soft Tissue Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
ORR: Percentage of Participants with Soft Tissue BOR of CR or PR
Duration of Response (DoR)
DOR
Time to Prostate Specific Antigen (PSA) Progression
Time to PSA progression
Prostate Specific Antigen (PSA) Response Rate (PSA-RR): Percentage of Participants with a PSA Decrease of at Least 50% from Baseline
PSA-RR
Pharmacokinetics (PK): Mean Concentrations of Abemaciclib and its Active Metabolite(s)
PK: Mean Concentrations of Abemaciclib and its Active Metabolite(s)
Pharmacokinetics (PK): Mean Concentrations of Darolutamide and its Active Metabolite
PK: Mean Concentrations of Darolutamide and its Active Metabolite

Full Information

First Posted
August 14, 2023
Last Updated
October 18, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05999968
Brief Title
Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
Official Title
A Phase 1b Study of Abemaciclib Plus Darolutamide in Men With Metastatic Castration-Resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 15, 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 9, 2024 (Anticipated)
Primary Completion Date
January 27, 2025 (Anticipated)
Study Completion Date
July 27, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with darolutamide to participants with prostate cancer that has spread after initial treatment. Participation may last up to 32 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abemaciclib + Darolutamide
Arm Type
Experimental
Arm Description
Abemaciclib plus (+) darolutamide. Participants who have not undergone bilateral orchiectomy are required to continue background androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist/antagonist throughout the study.
Intervention Type
Drug
Intervention Name(s)
Abemaciclib
Other Intervention Name(s)
LY2835219
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Darolutamide
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
LHRH agonist/antagonist
Intervention Description
Physician's choice. Administered in accordance with the prescribing information.
Primary Outcome Measure Information:
Title
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Description
Administration Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration
Time Frame
Date of first dose to study completion (approximately 32 months)
Secondary Outcome Measure Information:
Title
Radiographic Progression-Free Survival (rPFS) Assessed by Investigator rPFS Assessed by Investigator
Description
rPFS Assessed by Investigator
Time Frame
Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)
Title
Objective Response Rate (ORR): Percentage of Participants with Soft Tissue Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
Description
ORR: Percentage of Participants with Soft Tissue BOR of CR or PR
Time Frame
Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)
Title
Duration of Response (DoR)
Description
DOR
Time Frame
Date of first documented CR or PR to radiographic disease progression or death from any cause (approximately 32 months)
Title
Time to Prostate Specific Antigen (PSA) Progression
Description
Time to PSA progression
Time Frame
Date of first dose to the first observation of PSA progression (approximately 32 months)
Title
Prostate Specific Antigen (PSA) Response Rate (PSA-RR): Percentage of Participants with a PSA Decrease of at Least 50% from Baseline
Description
PSA-RR
Time Frame
Date of first dose to confirmed PSA progression (approximately 32 months)
Title
Pharmacokinetics (PK): Mean Concentrations of Abemaciclib and its Active Metabolite(s)
Description
PK: Mean Concentrations of Abemaciclib and its Active Metabolite(s)
Time Frame
Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)
Title
Pharmacokinetics (PK): Mean Concentrations of Darolutamide and its Active Metabolite
Description
PK: Mean Concentrations of Darolutamide and its Active Metabolite
Time Frame
Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate. Metastatic castration-resistant prostate cancer evidenced by: Prostate-specific antigen (PSA) or radiographic progression despite castrate levels of testosterone At least 1 bone metastasis on bone scan and/or 1 soft tissue metastasis on computed tomography/magnetic resonance imaging (CT/MRI) Participants who have not undergone bilateral orchiectomy must continue luteinizing-hormone-releasing hormone (LHRH) agonists/antagonists throughout the study. Have adequate organ function. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Exclusion Criteria: Prior treatment with cyclin-dependent kinase 4 and 6 (CDK4 and CDK6) inhibitors or darolutamide. Prior systemic therapy for metastatic castration-resistant prostate cancer(mCRPC) with cytotoxic chemotherapy, PARP inhibitors, novel hormonal agents (NHAs) (enzalutamide, apalutamide, and abiraterone), and radiopharmaceuticals. Serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study. Clinically significant heart disease as evidenced by myocardial infarction, arterial thrombotic events, severe or unstable angina, or congestive heart failure (New York Heart Association Class III or IV) within 6 months of assignment to treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@Lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Contact:
Phone
212-731-6366
First Name & Middle Initial & Last Name & Degree
David R Wise
Facility Name
Laura and Isaac Perlmutter Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Contact:
Phone
212-731-6366
First Name & Middle Initial & Last Name & Degree
David R Wise
Facility Name
Studienpraxis Urologie
City
Nürtingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72622
Country
Germany
Facility Contact:
Phone
4915201622246
First Name & Middle Initial & Last Name & Degree
Tilman Todenhöfer
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Contact:
Phone
040741057673
First Name & Middle Initial & Last Name & Degree
Gunhild Von Amsberg
Facility Name
Instituto Catalan de Oncologia - Hospital Duran i Reynals
City
L'Hospitalet de Llobregat
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
8907
Country
Spain
Facility Contact:
Phone
34932607744
First Name & Middle Initial & Last Name & Degree
Josep Maria Piulats Rodriguez
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28009
Country
Spain
Facility Contact:
Phone
34914265238
First Name & Middle Initial & Last Name & Degree
Jose Angel Arranz Arija
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28034
Country
Spain
Facility Contact:
Phone
349133682
First Name & Middle Initial & Last Name & Degree
Teresa Alonso Gordoa
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28041
Country
Spain
Facility Contact:
Phone
00349139083
First Name & Middle Initial & Last Name & Degree
Daniel Castellano Gauna
Facility Name
Hospital Infanta Cristina
City
Badajoz
ZIP/Postal Code
06006
Country
Spain
Facility Contact:
Phone
924218040
First Name & Middle Initial & Last Name & Degree
Marta Gonzalez Cordero
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JULIA Martinez Perez

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lilly.com/en-US/trial/418175
Description
Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment

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