Description:
This study is being done to see how safe and effective abemaciclib is when given together
with abiraterone acetate plus prednisone in participants with metastatic castration resistant
prostate cancer. Prednisolone may be used instead of prednisone per local regulation.
Title
- Brief Title: A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
- Official Title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer
Clinical Trial IDs
- ORG STUDY ID:
16598
- SECONDARY ID:
I3Y-MC-JPCM
- SECONDARY ID:
2016-004276-21
- NCT ID:
NCT03706365
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Abemaciclib | LY2835219 | A. Abiraterone plus Prednisone and Abemaciclib |
Abiraterone Acetate | | A. Abiraterone plus Prednisone and Abemaciclib |
Prednisone | | A. Abiraterone plus Prednisone and Abemaciclib |
Placebo | | B. Abiraterone plus Prednisone and Placebo |
Purpose
This study is being done to see how safe and effective abemaciclib is when given together
with abiraterone acetate plus prednisone in participants with metastatic castration resistant
prostate cancer. Prednisolone may be used instead of prednisone per local regulation.
Trial Arms
Name | Type | Description | Interventions |
---|
A1. Abiraterone plus Prednisone and Abemaciclib | Experimental | Abiraterone plus prednisone administered orally and abemaciclib administered orally. | - Abemaciclib
- Abiraterone Acetate
- Prednisone
|
A2. Abiraterone plus Prednisone and Abemaciclib | Experimental | Abiraterone plus prednisone administered orally and abemaciclib administered orally. | - Abemaciclib
- Abiraterone Acetate
- Prednisone
|
B1. Abiraterone plus Prednisone and Placebo | Active Comparator | Abiraterone plus prednisone administered orally and placebo administered orally. | - Abiraterone Acetate
- Prednisone
- Placebo
|
B2. Abiraterone plus Prednisone and Placebo | Active Comparator | Abiraterone plus prednisone administered orally and placebo administered orally. | - Abiraterone Acetate
- Prednisone
- Placebo
|
A. Abiraterone plus Prednisone and Abemaciclib | Experimental | Abiraterone plus prednisone administered orally and abemaciclib administered orally. | - Abemaciclib
- Abiraterone Acetate
- Prednisone
|
B. Abiraterone plus Prednisone and Placebo | Active Comparator | Abiraterone plus prednisone administered orally and placebo administered orally. | - Abiraterone Acetate
- Prednisone
- Placebo
|
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate.
- Metastatic prostate cancer documented by positive bone scan and/or measurable soft
tissue metastatic lesions by CT or magnetic resonance imaging (MRI).
- Progressive disease at study entry demonstrated during continuous androgen-deprivation
therapy (ADT)/post orchiectomy defined as one or more of the following:
- PSA progression
- Radiographic progression per Response Evaluation Criteria in Solid Tumors
(RECIST)1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3)
for bone, with or without PSA progression
- Have adequate organ function.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
Exclusion Criteria:
- Prior therapy with cytochrome P450 (CYP)17 inhibitors.
- Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 & 6
inhibitors.
- Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer
(participants treated with docetaxel in the metastatic hormone-sensitive prostate
cancer [mHSPC] are eligible). Prior radiopharmaceuticals for prostate cancer, or prior
enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who had prior
radiation or surgery to all target lesions.
- Currently enrolled in a clinical study involving an investigational product.
- Gastrointestinal disorder affecting the absorption or ability to swallow large pills.
- Clinically significant heart disease, active or chronic liver disease, moderate/severe
hepatic impairment (Child-Pugh Class B and C).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Radiographic Progression Free Survival (rPFS) |
Time Frame: | Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months) |
Safety Issue: | |
Description: | rPFS by investigator assessment |
Secondary Outcome Measures
Measure: | Time to Prostate-Specific Antigen (PSA) Progression |
Time Frame: | Baseline to the Date of the First Observation of PSA Progression (Estimated up to 21 Months) |
Safety Issue: | |
Description: | Time to PSA progression |
Measure: | Radiographic Progression Free Survival (rPFS) |
Time Frame: | Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months) |
Safety Issue: | |
Description: | rPFS by blinded, independent, central review |
Measure: | Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR) |
Time Frame: | Baseline to Radiographic Disease Progression (Estimated up to 21 Months) |
Safety Issue: | |
Description: | ORR: Percentage of participants with a CR or PR |
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 21 Months) |
Safety Issue: | |
Description: | DOR |
Measure: | Overall Survival (OS) |
Time Frame: | Baseline to Date of Death Due to Any Cause (Estimated up to 40 Months) |
Safety Issue: | |
Description: | OS |
Measure: | Time to Symptomatic Progression |
Time Frame: | Baseline to the Date of the First Documented Symptomatic Progression (Estimated up to 21 Months) |
Safety Issue: | |
Description: | Time to symptomatic progression |
Measure: | Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib |
Time Frame: | Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles) |
Safety Issue: | |
Description: | PK: Mean steady state exposure of abemaciclib |
Measure: | PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567 |
Time Frame: | Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles) |
Safety Issue: | |
Description: | PK: Mean steady state exposure of abemaciclib metabolite LSN2839567 |
Measure: | PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726 |
Time Frame: | Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles) |
Safety Issue: | |
Description: | PK: Mean steady state exposure of abemaciclib metabolite LSN3106726 |
Measure: | PK: Mean Steady State Exposure of Abiraterone Acetate |
Time Frame: | Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles) |
Safety Issue: | |
Description: | PK: Mean Steady State Exposure of Abiraterone Acetate |
Measure: | Time to Worst Pain Progression |
Time Frame: | Baseline through follow-up (Estimated up to 21 months) |
Safety Issue: | |
Description: | Measured by the Worst Pain Numeric Rating Scale (NRS) and World Health Organization-Analgesic Ladder (WHO-AL). NRS score measures worst pain over the last 24 hours on a 0 to 10-point NRS, where 0 -s "no pain" and 10 is "pain as bad as you can imagine. The WHO-AL classifies analgesic use into four categories, where 1 = no analgesic and 4 = strong opioids. |
Details
Phase: | Phase 2/Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Eli Lilly and Company |
Trial Keywords
- Metastatic Castration Resistant Prostate Cancer
- mCRPC
Last Updated
August 26, 2021