Prostatic Neoplasms
Conditions
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.
Interventions
DRUGAbemaciclib
Administered orally.
DRUGDarolutamide
Administered orally.
Physician's choice. Administered in accordance with the prescribing information.
Sponsors
Eli Lilly and Company
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 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) |
| 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 |
Countries
Germany, Spain, United States
Contacts
STUDY_DIRECTORCall 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
Outcome results
None listed