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CDK4/6 Inhibitor

Abemaciclib for Prostate Cancer (CYCLONE 1 Trial)

Phase 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first dose until objective progression (up to 12.8 months)
Awards & highlights

CYCLONE 1 Trial Summary

This trial will test how well abemaciclib works in treating men with prostate cancer that has spread after treatment.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer

CYCLONE 1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first dose until objective progression (up to 12.8 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose until objective progression (up to 12.8 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Confirmed Objective Response (Objective Response Rate [ORR])
Secondary outcome measures
Baseline Ki-67 Expression by Immunohistochemistry (IHC)
Duration of Response (DoR)
Overall Survival (OS)
+9 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
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Dry skin
8%
Thrombocytopenia
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Rash
5%
Gastrooesophageal reflux disease
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Sepsis
1%
Hip fracture
1%
Pneumonitis
1%
Fall
1%
Lung infection
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

CYCLONE 1 Trial Design

1Treatment groups
Experimental Treatment
Group I: 200 milligram (mg) Abemaciclib Twice DailyExperimental Treatment1 Intervention
Participants received 200 mg abemaciclib administered orally twice daily on a continuous dosing schedule (28-day cycle) until symptomatic and/or radiographic progression, unacceptable toxicity, or until another discontinuation criterion is met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1710

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,615 Previous Clinical Trials
3,201,014 Total Patients Enrolled
15 Trials studying Prostate Cancer
2,016 Patients Enrolled for Prostate Cancer
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,208 Total Patients Enrolled
6 Trials studying Prostate Cancer
1,142 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

What is the scope of participation in this trial?

"At this time, no additional participants are required for the outlined trial. It was published on January 20th 2021 and last modified November 22nd 2022. If you're looking for other opportunities, 1257 trials pertaining to prostate cancer and 92 focused on Abemaciclib are currently recruiting patients."

Answered by AI

For what purposes has Abemaciclib been employed?

"Abemaciclib is often employed to reduce the risk of recurrence for various medical conditions, like advanced HR+ HER2- breast cancer, endocrine therapy resistance and other forms of breast cancer."

Answered by AI

Is enrollment open for this research project?

"Sadly, no more patients are being recruited for this trial. It was initially shared on January 20th 2021 and the last update occured on November 22nd 2022. If you wish to consider other trials, 1257 studies about prostate cancer and 92 abemaciclib-related clinical trials are presently recruiting participants."

Answered by AI

Is this innovative clinical trial the pioneering effort in its field?

"Since 2009, Abemaciclib has been the subject of numerous clinical trials. Eli Lilly and Company launched the first study in 2009 with 220 participants; this experiment ultimately led to its Phase 1 drug approval. Currently there are 92 active research studies conducted on Abemaciclib across 41 countries in 1276 cities worldwide."

Answered by AI

Has the FDA sanctioned Abemaciclib for public use?

"Abemaciclib has some evidence of safety, so it received a rating of 2. However, there is presently no data that indicates its potential efficacy in clinical trials."

Answered by AI

Are there any additional investigations which have included Abemaciclib?

"Years ago, For initiated the exploration of Abemaciclib. To view a list of active research centres involved in this medical trial, please contact 1-877-CTLILLY or your personal doctor to learn more. Currently there are over 30 completed studies and 92 ongoing clinical trials which mainly take place within Boston, Massachusetts."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer
2021. "Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04408924.
~11 spots leftby Apr 2025
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