Description:
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.
Title
- Brief Title: Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer
- Official Title: CYCLONE 1: A Phase 2 Study of Abemaciclib in Metastatic Castration-Resistant Prostate Cancer Patients Previously Treated With a Novel Hormonal Agent and Taxane-based Chemotherapy
Clinical Trial IDs
- ORG STUDY ID:
17583
- SECONDARY ID:
I3Y-MC-JPCY
- SECONDARY ID:
2020-000290-24
- NCT ID:
NCT04408924
Conditions
- Metastatic Castration-Resistant Prostate Cancer
Interventions
Drug | Synonyms | Arms |
---|
Abemaciclib | LY2835219 | Abemaciclib |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Abemaciclib | Experimental | Abemaciclib given orally. | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) |
Time Frame: | Baseline to Objective Radiographic Soft Tissue Disease Progression (Estimated up to 12 Months) |
Safety Issue: | |
Description: | ORR: Percentage of Participants with Best Response of CR or PR |
Secondary Outcome Measures
Measure: | Radiographic Progression-Free Survival (rPFS) |
Time Frame: | Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 12 Months) |
Safety Issue: | |
Description: | rPFS |
Measure: | Overall Survival (OS) |
Time Frame: | Baseline to Date of Death Due to Any Cause (Estimated up to 24 Months) |
Safety Issue: | |
Description: | OS |
Measure: | Duration of Response (DOR) |
Time Frame: | Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Estimated up to 12 Months) |
Safety Issue: | |
Description: | DoR |
Measure: | Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR |
Time Frame: | Baseline to Radiographic Soft Tissue Disease Progression (Estimated up to 12 Months) |
Safety Issue: | |
Description: | DCR: Percentage of participants who exhibit SD, CR or PR |
Measure: | Prostate Specific Antigen (PSA) Response Rate |
Time Frame: | Baseline to Date of Treatment Discontinuation (Estimated up to 12 Months) |
Safety Issue: | |
Description: | PSA Response Rate: Percentage of Participants with a PSA Decrease of at Least 50% from Baseline |
Measure: | Time to PSA Progression |
Time Frame: | Baseline to the Date of First Observation of PSA Progression (Estimated up to 12 Months) |
Safety Issue: | |
Description: | Time to PSA Progression |
Measure: | Time to Symptomatic Progression |
Time Frame: | Baseline to the Date of First Documented Symptomatic Progression (Estimated up to 12 Months) |
Safety Issue: | |
Description: | Time to Symptomatic Progression |
Measure: | Patient-Reported Outcomes (PRO) |
Time Frame: | Baseline to End of Study (Estimated up to 12 Months) |
Safety Issue: | |
Description: | Patient-reported tolerability, including select symptomatic adverse events (from the PRO-Common Terminology Criteria for Adverse Events item library) and overall side-effect burden (item GP5 of the Functional Assessment of Cancer Therapy Tool General form (FACT-G)) |
Measure: | Pharmacokinetics (PK): Mean Steady State Concentration of Abemaciclib and its Metabolites |
Time Frame: | Predose Cycle 1 Day 15 through Predose Cycle 3 Day 1 (28 Day Cycles) |
Safety Issue: | |
Description: | PK: Mean Steady State Concentration of Abemaciclib and its Metabolites |
Measure: | Percentage of Ki-67 Positive Cells by Immunohistochemistry (IHC) |
Time Frame: | Baseline |
Safety Issue: | |
Description: | Percentage of Ki-67 positive cells by IHC |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Eli Lilly and Company |
Trial Keywords
- mCRPC
- CDK4
- CDK6
- CDK4/6
- CDK4&6 inhibitor
- CDK4/6 inhibitor
- LY2835219
- CYCLONE 1
- CYCLONE1
Last Updated
August 5, 2021