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Androgen Deprivation Therapy

Abemaciclib + Abiraterone for Prostate Cancer (CYCLONE 3 Trial)

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adenocarcinoma of the prostate.
Greater than or equal to (≥)4 bone metastases and/or ≥1 visceral metastases
Must not have
Prior treatment with abemaciclib or any other cyclin dependent kinase 4 and 6 (CDK4 & 6) inhibitor
Development of metastatic prostate cancer in the context of castrate levels of testosterone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization to the earliest date of psa or radiographic progression with a testosterone level of ≤50 nanogram/deciliter (ng/dl); or death from any cause (approximately 48 months)
Awards & highlights
Pivotal Trial

Summary

This trial is testing whether abemaciclib, when added to abiraterone plus prednisone, can help to treat prostate cancer by prolonging the time before the cancer gets worse.

Who is the study for?
Men with prostate cancer that has spread and is expected to respond to hormone therapy can join. They must have started hormone treatment before joining, have a good performance status, and not received certain other treatments for metastatic prostate cancer or have serious heart conditions.
What is being tested?
The study tests if adding abemaciclib to the standard treatment of abiraterone plus prednisone/prednisolone extends the time before prostate cancer worsens. Participants will be observed for up to 60 months.
What are the potential side effects?
Possible side effects include reactions related to liver function, cardiovascular issues like heart attacks or arrhythmias, and potential complications from drug interactions with existing medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is prostate adenocarcinoma.
Select...
I have 4 or more bone metastases and/or at least 1 visceral metastasis.
Select...
I have started hormone therapy for my cancer and will continue it during the study.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My prostate cancer is mainly adenocarcinoma.
Select...
My prostate cancer has spread to 4 or more bones or to my organs.
Select...
I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not taken abemaciclib or similar medications before.
Select...
My prostate cancer has spread and my testosterone levels are very low.
Select...
I have only received hormone therapy for my metastatic prostate cancer.
Select...
I have not had a heart attack or severe heart issues in the last 6 months.
Select...
My high blood pressure is not under control.
Select...
I have a serious liver condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization to the earliest date of psa or radiographic progression with a testosterone level of ≤50 nanogram/deciliter (ng/dl); or death from any cause (approximately 48 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to the earliest date of psa or radiographic progression with a testosterone level of ≤50 nanogram/deciliter (ng/dl); or death from any cause (approximately 48 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Radiographic Progression-Free Survival (rPFS) Assessed by Investigator
Secondary study objectives
Castration-resistant Prostate Cancer (CRPC)-free Survival
Overall Survival (OS)
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
+3 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490
91%
Diarrhoea
67%
Nausea
48%
Fatigue
45%
Decreased appetite
35%
Vomiting
27%
Anaemia
26%
Abdominal pain
23%
Asthenia
23%
Neutrophil count decreased
21%
Cough
20%
Constipation
20%
Headache
19%
Arthralgia
18%
White blood cell count decreased
18%
Neutropenia
15%
Alopecia
14%
Dry mouth
14%
Platelet count decreased
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Oedema peripheral
11%
Dyspepsia
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Pneumonitis
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Abemaciclib + Abiraterone + Prednisone/PrednisoloneExperimental Treatment3 Interventions
Abemaciclib plus (+) abiraterone + prednisone/prednisolone administered orally.
Group II: Placebo + Abiraterone + Prednisone/PrednisoloneActive Control3 Interventions
Placebo + abiraterone + prednisone/prednisolone administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone
2012
Completed Phase 4
~4490
Prednisone or Prednisolone
2011
Completed Phase 3
~1260
Abemaciclib
2019
Completed Phase 2
~1890

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,672 Previous Clinical Trials
3,462,893 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,386 Previous Clinical Trials
425,798 Total Patients Enrolled

Media Library

Abiraterone (Androgen Deprivation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05288166 — Phase 3
Cytochrome P450 Research Study Groups: Abemaciclib + Abiraterone + Prednisone/Prednisolone, Placebo + Abiraterone + Prednisone/Prednisolone
Cytochrome P450 Clinical Trial 2023: Abiraterone Highlights & Side Effects. Trial Name: NCT05288166 — Phase 3
Abiraterone (Androgen Deprivation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05288166 — Phase 3
~251 spots leftby Nov 2025
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