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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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to date of death due to any cause (estimated up to 40 months)

Awards & highlights

CYCLONE 2 Trial 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.Check my eligibility

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.See study design

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.

CYCLONE 2 Trial 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.

CYCLONE 2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to date of death due to any cause (estimated up to 40 months)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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%

Platelet count decreased

14%

Dry mouth

14%

Weight decreased

14%

Dysgeusia

13%

Dyspnoea

12%

Abdominal pain upper

12%

Back pain

12%

Dizziness

11%

Pyrexia

11%

Dyspepsia

11%

Oedema peripheral

11%

Blood creatinine increased

10%

Pain

Stomatitis

Aspartate aminotransferase increased

Dry skin

Thrombocytopenia

Pruritus

Lacrimation increased

Dehydration

Alanine aminotransferase increased

Flatulence

Urinary tract infection

Upper respiratory tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Rash

Gastrooesophageal reflux disease

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Sepsis

Hip fracture

Pneumonitis

Fall

Lung infection

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

Study treatment Arm

Abemaciclib

CYCLONE 2 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

~2370

Abiraterone Acetate

2015

Completed Phase 4

~1880

Abemaciclib

2019

Completed Phase 2

~1710

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,613 Previous Clinical Trials

3,200,579 Total Patients Enrolled

14 Trials studying Prostate Cancer

1,666 Patients Enrolled for Prostate Cancer

Study DirectorEli Lilly and Company

1,344 Previous Clinical Trials

404,902 Total Patients Enrolled

5 Trials studying Prostate Cancer

792 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why is Abemaciclib most often prescribed?

"While Abemaciclib is commonly used to treat lupus erythematosus, it can also help patients with thyroiditis, ulcerative colitis, and a high risk of recurrence."

Answered by AI

Is this the first time that Abemaciclib has been trialed?

"There are a total of 470 studies being conducted that are investigating Abemaciclib. Out of those, 116 are live clinical trials that are in Phase 3. However, the majority of studies for Abemaciclib are not based in Duarte, California-- there are 21975 locations running trials for this treatment across the globe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

2018. "A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03706365.

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