Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
- Conditions
- Prostatic Neoplasms
- Interventions
- Registration Number
- NCT05999968
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 10
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Abemaciclib + Darolutamide LHRH agonist/antagonist 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. Abemaciclib + Darolutamide Abemaciclib 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. Abemaciclib + Darolutamide Darolutamide 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.
- Primary Outcome Measures
Name Time Method Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Date of first dose to study completion (approximately 32 months) Administration Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR): Percentage of Participants with Soft Tissue Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) Date of first dose to radiographic disease progression or death from any cause (approximately 32 months) ORR: Percentage of Participants with Soft Tissue BOR of CR or PR
Prostate Specific Antigen (PSA) Response Rate (PSA-RR): Percentage of Participants with a PSA Decrease of at Least 50% from Baseline Date of first dose to confirmed PSA progression (approximately 32 months) PSA-RR
Pharmacokinetics (PK): Mean Concentrations of Darolutamide and its Active Metabolite Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days) PK: Mean Concentrations of Darolutamide and its Active Metabolite
Pharmacokinetics (PK): Mean Concentrations of Abemaciclib and its Active Metabolite(s) Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days) PK: Mean Concentrations of Abemaciclib and its Active Metabolite(s)
Radiographic Progression-Free Survival (rPFS) Assessed by Investigator rPFS Assessed by Investigator Date of first dose to radiographic disease progression or death from any cause (approximately 32 months) rPFS Assessed by Investigator
Duration of Response (DoR) Date of first documented CR or PR to radiographic disease progression or death from any cause (approximately 32 months) DOR
Time to Prostate Specific Antigen (PSA) Progression Date of first dose to the first observation of PSA progression (approximately 32 months) Time to PSA progression
Trial Locations
- Locations (13)
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Madrid, Comunidad De, Spain
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
Studienpraxis Urologie
🇩🇪Nürtingen, Baden-Württemberg, Germany
Klinikum Rechts Der Isar Der Technischen Universität München
🇩🇪Munich, Bayern, Germany
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Schleswig-Holstein, Germany
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
🇺🇸Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center
🇺🇸New York, New York, United States
Instituto Catalan de Oncologia - Hospital Duran i Reynals
🇪🇸L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Infanta Cristina
🇪🇸Badajoz, Spain
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain