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Steroidogenesis Inhibitor

Abiraterone + Prednisone +/- Abemaciclib for Prostate Cancer (CYCLONE 2 Trial)

Phase 2 & 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
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.
Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or magnetic resonance imaging (MRI).
Must not have
Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 & 6 inhibitors.
Gastrointestinal disorder affecting the absorption or ability to swallow large pills.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to date of death due to any cause (estimated up to 40 months)

Summary

This trial is testing a new combination of drugs for prostate cancer that has spread and is no longer responding to hormone therapy.

Who is the study for?
Men with advanced prostate cancer that has spread and is resistant to hormone therapy can join. They must have a specific type of prostate cancer confirmed by tests, worsening disease despite ongoing hormone treatment, and their body should be functioning well enough (ECOG 0-1). Men who've had certain other treatments or have serious heart, liver, or digestive problems cannot participate.
What is being tested?
The trial is testing the safety and effectiveness of adding abemaciclib to the standard treatment for this stage of prostate cancer: abiraterone acetate plus prednisone. Some participants will receive a placebo instead of abemaciclib to compare outcomes.
What are the potential side effects?
Abemaciclib may cause diarrhea, fatigue, nausea, low blood cell counts increasing infection risk; Abiraterone Acetate might lead to high blood pressure, fluid retention; Prednisone can cause weight gain, mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer has spread, confirmed by a bone scan or CT/MRI.
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My prostate cancer is confirmed by tissue analysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not taken abemaciclib or any CDK 4 & 6 inhibitors before.
Select...
I have a stomach or intestine problem that makes it hard for me to absorb medicine or swallow big pills.
Select...
I have been treated with CYP17 inhibitors before.
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I do not have serious heart or liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to date of death due to any cause (estimated up to 40 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to date of death due to any cause (estimated up to 40 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Duration of Response (DOR)
Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)
Overall Survival (OS)
+8 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

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: A2. Abiraterone plus Prednisone and AbemaciclibExperimental Treatment3 Interventions
Abiraterone plus prednisone administered orally and abemaciclib administered orally.
Group II: A1. Abiraterone plus Prednisone and AbemaciclibExperimental Treatment3 Interventions
Abiraterone plus prednisone administered orally and abemaciclib administered orally.
Group III: A. Abiraterone plus Prednisone and AbemaciclibExperimental Treatment3 Interventions
Abiraterone plus prednisone administered orally and abemaciclib administered orally.
Group IV: B1. Abiraterone plus Prednisone and PlaceboActive Control3 Interventions
Abiraterone plus prednisone administered orally and placebo administered orally.
Group V: B2. Abiraterone plus Prednisone and PlaceboActive Control3 Interventions
Abiraterone plus prednisone administered orally and placebo administered orally.
Group VI: B. Abiraterone plus Prednisone and PlaceboActive Control3 Interventions
Abiraterone plus prednisone administered orally and placebo administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2500
Abiraterone Acetate
2015
Completed Phase 4
~1880
Abemaciclib
2019
Completed Phase 2
~1890

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,671 Previous Clinical Trials
3,228,672 Total Patients Enrolled
16 Trials studying Prostate Cancer
1,944 Patients Enrolled for Prostate Cancer
Study DirectorEli Lilly and Company
1,386 Previous Clinical Trials
426,297 Total Patients Enrolled
7 Trials studying Prostate Cancer
1,292 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone Acetate (Steroidogenesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03706365 — Phase 2 & 3
Prostate Cancer Research Study Groups: A2. Abiraterone plus Prednisone and Abemaciclib, A1. Abiraterone plus Prednisone and Abemaciclib, B1. Abiraterone plus Prednisone and Placebo, A. Abiraterone plus Prednisone and Abemaciclib, B2. Abiraterone plus Prednisone and Placebo, B. Abiraterone plus Prednisone and Placebo
Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT03706365 — Phase 2 & 3
Abiraterone Acetate (Steroidogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03706365 — Phase 2 & 3
~51 spots leftby Nov 2025
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