Phase 2
N=44
Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04408924 ↗Enrolled (actual)
44
Serious AEs
40.9%
Results posted
May 2023
Primary outcome: Primary: Percentage of Participants With Confirmed Objective Response (Objective Response Rate [ORR]) — 6.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Abemaciclib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Confirmed Objective Response (Objective Response Rate [ORR]) |
6.8 | — |
| SECONDARY Radiographic Progression-Free Survival (rPFS) |
2.7 | — |
| SECONDARY Overall Survival (OS) |
8.38 | — |
| SECONDARY Duration of Response (DoR) |
NA | — |
| SECONDARY Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR]) |
45.5 | — |
| SECONDARY Time to Prostate-Specific Antigen (PSA) Progression |
6.5 | — |
| SECONDARY Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response (PSA Response Rate) |
4.6 | — |
| SECONDARY Time to Symptomatic Progression |
4.1 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib |
223 | — |
| SECONDARY PK: Minimum/Trough Concentration at Steady State (Cmin,ss) of Abemaciclib |
176 | — |
| SECONDARY PK: Maximum Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib Metabolites (Total Active Species) |
1.7 | — |
| SECONDARY PK: Minimum/Trough Concentration at Steady State (Cmin,ss) of Abemaciclib Metabolites (Total Active Species) |
1.5 | — |
| SECONDARY Percentage of Participants With Expression of Ki-67 Proliferation Marker by Immunohistochemistry (IHC) |
25.8; 74.2 | — |
Summary
The study will evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.
Eligibility Criteria
Inclusion Criteria
- Participant must have metastatic prostate cancer for which castration (medical or surgical) is no longer effective (castration-resistant).
- Participant must have disease spread to soft tissue that is measurable.
- Participant must have documented evidence of progressive disease by PSA test or imaging.
- Participant must have previously received at least one of the following treatment: abiraterone acetate, apalutamide, darolutamide or enzalutamide.
- Participant must have previously received chemotherapy with docetaxel and cabazitaxel.
- Participant must be willing and amenable to undergo a biopsy of tumor tissue (or able to provide adequate archived tumor tissue sample) and to provide blood for research.
- Participant must have good physical functioning ability and adequate organ function.
Exclusion Criteria
- Participant must not have received more than 3 therapy regimens for metastatic castration-resistant prostate cancer (NOTE: GnRHa, first-generation antiandrogens (flutamide, nilutamide, or bicalutamide), diethylstilbestrol (DES) (or other estrogens), corticosteroids, ketoconazole, and bone loss-prevention will not count as systemic therapy regimens.
- Participants must not have previously received abemaciclib or any cyclin-dependent kinase (CDK)4 and/or CDK6 inhibitors.
- Participants must not have serious and/or uncontrolled preexisting medical condition(s) including but not limited to severe renal impairment, severe hepatic impairment, interstitial lung disease (ILD)/pneumonitis, severe dyspnea at rest or requiring oxygen therapy or other serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
- Participants must not have, or suspected to have, brain metastasis.
- Participants must not have untreated spinal cord compression, evidence of spinal metastases with risk of spinal compression or structurally unstable bone lesions suggesting impending fracture.
Data sourced from ClinicalTrials.gov (NCT04408924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.