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Trial Title:
Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
NCT ID:
NCT05999968
Condition:
Prostatic Neoplasms
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Abemaciclib
Description:
Administered orally.
Arm group label:
Abemaciclib + Darolutamide
Other name:
LY2835219
Intervention type:
Drug
Intervention name:
Darolutamide
Description:
Administered orally.
Arm group label:
Abemaciclib + Darolutamide
Intervention type:
Drug
Intervention name:
LHRH agonist/antagonist
Description:
Physician's choice. Administered in accordance with the prescribing information.
Arm group label:
Abemaciclib + Darolutamide
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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Highlands Oncology Group
Address:
City:
Springdale
Zip:
72762
Country:
United States
Facility:
Name:
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Address:
City:
Mineola
Zip:
11501
Country:
United States
Facility:
Name:
Laura and Isaac Perlmutter Cancer Center
Address:
City:
New York
Zip:
10016
Country:
United States
Facility:
Name:
Studienpraxis Urologie
Address:
City:
Nürtingen
Zip:
72622
Country:
Germany
Facility:
Name:
Klinikum Rechts Der Isar Der Technischen Universität München
Address:
City:
Munich
Zip:
81675
Country:
Germany
Facility:
Name:
Universitätsklinikum Schleswig-Holstein
Address:
City:
Lübeck
Zip:
23538
Country:
Germany
Facility:
Name:
Universitaetsklinikum Hamburg-Eppendorf
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Facility:
Name:
Instituto Catalan de Oncologia - Hospital Duran i Reynals
Address:
City:
L'Hospitalet de Llobregat
Zip:
8907
Country:
Spain
Facility:
Name:
Hospital General Universitario Gregorio Marañon
Address:
City:
Madrid
Zip:
28009
Country:
Spain
Facility:
Name:
Hospital Universitario Ramón y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Facility:
Name:
Hospital Infanta Cristina
Address:
City:
Badajoz
Zip:
06006
Country:
Spain
Facility:
Name:
Hospital Universitario Virgen Del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Start date:
January 12, 2024
Completion date:
July 2026
Lead sponsor:
Agency:
Eli Lilly and Company
Agency class:
Industry
Collaborator:
Agency:
Bayer
Agency class:
Industry
Source:
Eli Lilly and Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05999968
https://trials.lilly.com/en-US/trial/418175
