Trial · NCT03706365
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
NCT03706365, Phase 2, Phase 3, Active not recruiting, Eli Lilly and Company; results first posted 2025-03-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer. Trials, record NCT03706365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03706365
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
- NCT number
- NCT03706365
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 393 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Prostate Cancer
- Interventions
- Abemaciclib, Placebo, Abiraterone acetate, Prednisone
- First posted
- 2018-10-16
- Last updated
- 2026-08-07
- Other registries' IDs
- eudract:2016-004276-21
- Results first posted
- 2025-03-06
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Radiographic Progression Free Survival (rPFS) | From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months) | The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first. |
| Secondary | Time to Prostate-Specific Antigen (PSA) Progression | From Date of Randomization to the Date of the First Observation of PSA Progression (Up to 60 Months) | The PSA progression is defined as a greater than or equal to (\>=) 25 percentage (%) increase and an absolute increase of \>=2 nanogram/milliliter (ng/mL) above the nadir (or baseline value if baseline is the smallest on study), which is confirmed by a second value obtained 3 or more weeks later. |
| Secondary | Radiographic Progression Free Survival (rPFS) Determined by Blinded Independent Central Review | From Date of Randomization Until Radiographic Disease Progression or Death from Any Cause (Up to 60 Months) | rPFS is defined as the time from the date of randomization to the earliest date of radiographic disease progression determined by blinded independent central review (BICR) or death from any cause, whichever occurs first. |
| Secondary | Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | Baseline to Radiographic Disease Progression (Up to 60 Months) | ORR is a summary measure of best overall response (BOR) as defined by RECIST 1.1 for soft tissue per investigator assessment. BOR is derived from time point responses. All time point responses observed while on study treatment and during the short-term follow-up period (but before the initiation of post-discontinuation systemic anticancer therapy) will be included in the derivation. Each patient's BOR will be categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). A BOR of CR or PR will require confirmation, but sensitivity analyses of response-based endpoints may be performed where confirmation of a BOR of CR or PR is not required. |
| Secondary | Duration of Response (DOR) | Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Up to 60 Months) | The DoR time is defined only for responders (participants with a soft tissue BOR of CR or PR) in the measurable disease population. It is measured from the date of first evidence of soft tissue CR or PR to the earliest date of investigator determined radiographic disease progression or death from any cause, whichever is earlier. |
| Secondary | Overall Survival (OS) | From Date of Randomization to Date of Death Due to Any Cause (Up to 60 Months) | The OS time is measured from the date of randomization to the date of death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive. |
| Secondary | Time to Symptomatic Progression | From Randomization to the Date of the First Documented Symptomatic Progression (Up to 60 Months) | Time to symptomatic progression is defined as the time from randomization to any of the following (whichever occurs earlier): 1. Symptomatic Skeletal Event (SSE), defined as symptomatic fracture, surgery or radiation to bone, or spinal cord compression. 2. Pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy. 3. Development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy. |
| Secondary | Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib | Cycle (C) 1 Day (D) 1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle) | PK: Mean steady state exposure of abemaciclib. |
| Secondary | PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567 | C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle) | PK: Mean steady state exposure of abemaciclib metabolite LSN2839567. |
| Secondary | PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726 | C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle) | PK: Mean steady state exposure of abemaciclib metabolite LSN3106726. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Radiographic Progression Free Survival (rPFS) | From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months) | All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Months | MEDIAN |
| SECONDARY | Time to Prostate-Specific Antigen (PSA) Progression | From Date of Randomization to the Date of the First Observation of PSA Progression (Up to 60 Months) | All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Months | MEDIAN |
| SECONDARY | Radiographic Progression Free Survival (rPFS) Determined by Blinded Independent Central Review | From Date of Randomization Until Radiographic Disease Progression or Death from Any Cause (Up to 60 Months) | All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | Baseline to Radiographic Disease Progression (Up to 60 Months) | All randomized participants who received at least one dose of the study drug and had CR or PR responses. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Up to 60 Months) | All randomized participants who received at least one dose of the study drug and had CR or PR responses with objective response. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From Date of Randomization to Date of Death Due to Any Cause (Up to 60 Months) | All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Months | MEDIAN |
| SECONDARY | Time to Symptomatic Progression | From Randomization to the Date of the First Documented Symptomatic Progression (Up to 60 Months) | All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received. | Months | MEDIAN |
| SECONDARY | Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib | Cycle (C) 1 Day (D) 1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle) | All participants who received at least one dose of study drug had evaluable PK data. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567 | C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle) | All participants who received at least one dose of study drug had evaluable PK data. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726 | C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle) | All participants who received at least one dose of study drug had evaluable PK data. | ng/mL | GEOMETRIC_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Radiographic Progression Free Survival (rPFS) | Abemaciclib | 21.96 | 95% Confidence Interval 19.33 to 27.48 | Months | |
| Radiographic Progression Free Survival (rPFS) | Placebo | 20.28 | 95% Confidence Interval 16.47 to 24.36 | Months | |
| Time to Prostate-Specific Antigen (PSA) Progression | Abemaciclib | 22.19 | 95% Confidence Interval 15.68 to 33.17 | Months | |
| Time to Prostate-Specific Antigen (PSA) Progression | Placebo | 16.60 | 95% Confidence Interval 12.03 to 20.28 | Months | |
| Radiographic Progression Free Survival (rPFS) Determined by Blinded Independent Central Review | Abemaciclib | 24.89 | 95% Confidence Interval 21.96 to NA | Months | |
| Radiographic Progression Free Survival (rPFS) Determined by Blinded Independent Central Review | Placebo | 22.88 | 95% Confidence Interval 19.36 to 31.50 | Months | |
| Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | Abemaciclib | 45.2 | 95% Confidence Interval 34.6 to 55.9 | percentage of participants | |
| Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | Placebo | 54.8 | 95% Confidence Interval 43.4 to 66.2 | percentage of participants | |
| Duration of Response (DOR) | Abemaciclib | 21.27 | 95% Confidence Interval 16.60 to NA | Months | |
| Duration of Response (DOR) | Placebo | 15.68 | 95% Confidence Interval 11.87 to 39.35 | Months |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abemaciclib | 206 | |
| Overall Study | STARTED | Placebo | 187 | |
| Overall Study | Received at Least One Dose of Study Drug | Abemaciclib | 206 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo | 185 | |
| Overall Study | COMPLETED | Abemaciclib | 131 | |
| Overall Study | COMPLETED | Placebo | 121 | |
| Overall Study | NOT COMPLETED | Abemaciclib | 75 | |
| Overall Study | NOT COMPLETED | Placebo | 66 |
Source ClinicalTrials.gov
Adverse events1,634
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Abemaciclib | 91 | 206 | 164 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 21 | 185 | 30 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Abemaciclib | 1 | 206 | 1 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Placebo | 0 | 185 | 0 |
| other | Anaemia megaloblastic | Blood and lymphatic system disorders | Abemaciclib | 1 | 206 | 1 |
| other | Anaemia megaloblastic | Blood and lymphatic system disorders | Placebo | 0 | 185 | 0 |
| other | Bone marrow disorder | Blood and lymphatic system disorders | Abemaciclib | 1 | 206 | 1 |
| other | Bone marrow disorder | Blood and lymphatic system disorders | Placebo | 0 | 185 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | Abemaciclib | 0 | 206 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | Placebo | 1 | 185 | 1 |
1 to 10 of 1,634Source ClinicalTrials.gov
See all 1,634 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abemaciclib | 81 | 206 |
| Total, all-cause mortality | Placebo | 72 | 187 |
| Total, other adverse events | Abemaciclib | 204 | 206 |
| Total, other adverse events | Placebo | 176 | 185 |
| Total, serious adverse events | Abemaciclib | 89 | 206 |
| Total, serious adverse events | Placebo | 66 | 185 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41167216 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Abemaciclib vs Placebo: deaths from any cause | Trial comparisons |
| Abemaciclib vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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