All > Bone Metastases > Louisiana

Abemaciclib for Prostate Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Thomayerova nemocnice, Prague, CzechiaProstate Cancer+16 MoreAbemaciclib - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Prostate Cancer
  • Abiraterone Acetate
  • Enzyme Inhibitors
  • Prednisolone
  • Androgens
  • Hormone Therapy
  • Cyclin-Dependent Kinase 6
  • Urogenital Neoplasms
  • Steroid Synthesis Inhibitors
  • Cyclin-Dependent Kinase 4 (CDK4)
  • Drug Effects
  • Chemotherapy
  • Metastatic Cancer
  • Hormonal Antineoplastic Agents
  • Hormones
  • Cytochrome P450
  • Prednisone

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Abemaciclib
1
abemaciclib + temozolomide
1
Abemaciclib

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 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)

Month 60
Overall Survival (OS)
Day 28
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
Month 48
Time to Pain Progression
Month 48
Radiographic Progression-Free Survival (rPFS) Assessed by Investigator
rPFS Assessed by Blinded Independent Central Review (BICR)
Month 48
Time to Deterioration in Health-Related Quality of Life (HRQoL)
Month 48
Castration-resistant Prostate Cancer (CRPC)-free Survival

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Abemaciclib
1
abemaciclib + temozolomide
1
Abemaciclib

Side Effects for

Abemaciclib
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%Dysgeusia
14%Platelet count decreased
14%Dry mouth
14%Weight decreased
13%Dyspnoea
12%Abdominal pain upper
12%Back pain
12%Dizziness
11%Pyrexia
11%Blood creatinine increased
11%Oedema peripheral
11%Dyspepsia
10%Pain
9%Stomatitis
9%Aspartate aminotransferase increased
8%Thrombocytopenia
8%Lacrimation increased
8%Pruritus
8%Dry skin
8%Dehydration
8%Alanine aminotransferase increased
7%Upper respiratory tract infection
7%Flatulence
7%Urinary tract infection
7%Hypokalaemia
6%Musculoskeletal pain
6%Chills
6%Musculoskeletal chest pain
6%Anxiety
5%Myalgia
5%Gastrooesophageal reflux disease
5%Rash
2%Cellulitis
2%Pleural effusion
1%Large intestinal obstruction
1%Lung infection
1%Pneumothorax
1%Arterial thrombosis
1%Sinus bradycardia
1%Sepsis
1%Hip fracture
1%Respiratory tract infection
1%Renal function test abnormal
1%Liver function test abnormal
1%Fall
1%Pulmonary embolism
1%Gastroenteritis viral
1%Tachycardia
1%Haematotoxicity
1%Pancreatitis
1%Varices oesophageal
1%Electrocardiogram abnormal
1%Muscular weakness
1%Bone pain
1%Acute kidney injury
1%Febrile neutropenia
1%Pancreatic enzyme abnormality
1%Atypical pneumonia
1%Pneumonitis
1%Epilepsy
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02102490) in the Abemaciclib ARM group. Side effects include: Diarrhoea with 91%, Nausea with 67%, Fatigue with 48%, Decreased appetite with 45%, Vomiting with 35%.

Trial Design

2 Treatment Groups

Placebo + Abiraterone + Prednisone/Prednisolone
1 of 2
Abemaciclib + Abiraterone + Prednisone/Prednisolone
1 of 2

Active Control

Experimental Treatment

900 Total Participants · 2 Treatment Groups

Primary Treatment: Abemaciclib · Has Placebo Group · Phase 3

Abemaciclib + Abiraterone + Prednisone/PrednisoloneExperimental Group · 3 Interventions: Prednisone or Prednisolone, Abemaciclib, Abiraterone · Intervention Types: Drug, Drug, Drug
Placebo + Abiraterone + Prednisone/PrednisoloneActiveComparator Group · 3 Interventions: Prednisone or Prednisolone, Placebo for Abemaciclib, Abiraterone · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone or Prednisolone
2011
Completed Phase 3
~1260
Abemaciclib
2019
Completed Phase 2
~1690
Abiraterone
2012
Completed Phase 4
~1750

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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)

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,482 Previous Clinical Trials
3,142,246 Total Patients Enrolled
14 Trials studying Prostate Cancer
1,736 Patients Enrolled for Prostate Cancer
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,268 Previous Clinical Trials
370,397 Total Patients Enrolled
6 Trials studying Prostate Cancer
1,142 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Virginia100.0%
How old are they?
65+100.0%
What site did they apply to?
Chesapeake Urology100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

Frequently Asked Questions

What is the standing of Abemaciclib with the FDA?

"Abemaciclib's safety is estimated to be a 3. Phase 3 trials have some data supporting efficacy and multiple rounds of data supporting safety." - Anonymous Online Contributor

Unverified Answer

Where can potential participants find this clinical trial?

"There are 78 locations associated with this trial, but a few notable locations are Texas Oncology - Carrollton in Carrollton, Texas, Genesis Cancer Center in Hot Springs, Arkansas, and Providence Medical Foundation in Fullerton, California." - Anonymous Online Contributor

Unverified Answer

Are we still receiving participants for this experiment?

"The clinical trial is recruiting patients at this time, as reflected on clinicaltrials.gov. This specific trial was first posted on April 14th, 2022 and received its most recent update on October 19th, 2022." - Anonymous Online Contributor

Unverified Answer

How many participants are being enrolled in this experiment?

"In order to begin this study, 900 individuals that fit the pre-determined criteria must enroll. These participants can be located at various medical facilities, such as Texas Oncology - Carrollton or Genesis Cancer Center." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top