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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Administered orally.
Administered orally.
Physician's choice. Administered in accordance with the prescribing information.
Highlands Oncology Group
Springdale, Arkansas, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center
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
Time frame: Date of first dose to study completion (approximately 32 months)
Radiographic Progression-Free Survival (rPFS) Assessed by Investigator rPFS Assessed by Investigator
rPFS Assessed by Investigator
Time frame: Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)
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
Time frame: Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)
Duration of Response (DoR)
DOR
Time frame: Date of first documented CR or PR to radiographic disease progression or death from any cause (approximately 32 months)
Time to Prostate Specific Antigen (PSA) Progression
Time to PSA progression
Time frame: Date of first dose to the first observation of PSA progression (approximately 32 months)
Prostate Specific Antigen (PSA) Response Rate (PSA-RR): Percentage of Participants with a PSA Decrease of at Least 50% from Baseline
PSA-RR
Time frame: Date of first dose to confirmed PSA progression (approximately 32 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
New York, New York, United States
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg, Germany
Klinikum Rechts Der Isar Der Technischen Universität München
Munich, Bavaria, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany
Instituto Catalan de Oncologia - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
...and 3 more locations
Pharmacokinetics (PK): Mean Concentrations of Abemaciclib and its Active Metabolite(s)
PK: Mean Concentrations of Abemaciclib and its Active Metabolite(s)
Time frame: Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)
Pharmacokinetics (PK): Mean Concentrations of Darolutamide and its Active Metabolite
PK: Mean Concentrations of Darolutamide and its Active Metabolite
Time frame: Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)