← Back to Search

Cyclin-Dependent Kinase Inhibitor

Darolutamide + Abemaciclib for Prostate Cancer

Phase 1 & 2
Waitlist Available
Led By Praful Ravi, MB BChir, MRCP
Research Sponsored by Praful Ravi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males ≥18 years
Histologically or cytologically confirmed adenocarcinoma of the prostate without histologic variants comprising >50% of the sample as determined by academic medical center pathology review
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2, 3, and 5 years.
Awards & highlights

Study Summary

This trial is researching the safety and effectiveness of two oral drugs (Darolutamide and Abemaciclib) combined with androgen deprivation therapy for prostate cancer. 93 patients will take part for 6 months with up to 4.5 years of follow-up.

Who is the study for?
Men over 18 with confirmed prostate adenocarcinoma, able to swallow pills and follow study rules. They must have a recent biopsy showing significant cancer presence without certain variants, no metastatic disease by specific scans, be candidates for surgical removal of the prostate, and have proper organ function. Contraception is required during and after the trial.Check my eligibility
What is being tested?
The trial tests combining two oral drugs (abemaciclib and darolutamide) with standard hormone therapy for various stages of prostate cancer. The first phase will determine safe dosages before expanding into broader testing. About 93 participants will undergo treatment for six months followed by up to four-and-a-half years of monitoring.See study design
What are the potential side effects?
Potential side effects include fatigue, digestive issues like nausea or diarrhea, blood cell count changes leading to increased infection risk or bleeding problems, liver function alterations, allergic reactions, and possibly others not yet known.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man aged 18 or older.
Select...
My prostate cancer is mainly adenocarcinoma, confirmed by a specialist review.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My prostate cancer is advanced but hasn't spread or has spread, and it's getting worse despite hormone therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2, 3, and 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2, 3, and 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1 - Dose Limiting Toxicity (DLT)
Phase 1 - Maximum Tolerated Dose (MTD)
Phase 1 - Recommended Phase 2 Dose (RP2D)
+1 more
Secondary outcome measures
Phase 1 & 2 - Grade 3 or Higher Treatment-Related Toxicity Rate
Phase 1 - Median Radiographic Progression-Free Survival (rPFS)
Phase 1 - Objective Response Rate (ORR)
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Phase 2 - Neoadjuvant Darolutamide, Ademaciclib, and ADT prior to Radical ProstatectomyExperimental Treatment5 Interventions
per protocol, for 6, 28-day cycles
Group II: Phase 2 - Neoadjuvant Darolutamide and ADT prior to Radical ProstatectomyExperimental Treatment4 Interventions
per protocol, for 6, 28-day cycles
Group III: Phase 1 Lead In in CRPCExperimental Treatment5 Interventions
Standard 3+3 dose escalation scheme with 3 dose levels of abemaciclib and a constant dose of darolutamide, per protocol, for 6, 28-day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Degarelix
2002
Completed Phase 3
~3600
Darolutamide
2018
Completed Phase 2
~100
Abemaciclib
2019
Completed Phase 2
~1550

Find a Location

Who is running the clinical trial?

Praful RaviLead Sponsor
Praful Ravi, MB BCHir, MRCPLead Sponsor
Eli Lilly and CompanyIndustry Sponsor
2,605 Previous Clinical Trials
3,199,577 Total Patients Enrolled
14 Trials studying Prostate Cancer
1,923 Patients Enrolled for Prostate Cancer

Media Library

Abemaciclib (Cyclin-Dependent Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05617885 — Phase 1 & 2
Prostate Cancer Research Study Groups: Phase 1 Lead In in CRPC, Phase 2 - Neoadjuvant Darolutamide and ADT prior to Radical Prostatectomy, Phase 2 - Neoadjuvant Darolutamide, Ademaciclib, and ADT prior to Radical Prostatectomy
Prostate Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT05617885 — Phase 1 & 2
Abemaciclib (Cyclin-Dependent Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05617885 — Phase 1 & 2

Frequently Asked Questions

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

What are the goals that researchers hope to achieve with this clinical trial?

"The primary goal of this study, which will be assessed over the course of 28 days in Cycle 1 and up to 6 months, is Pathological Response Rate inPhase 2. Additionally, researchers are measuring secondary objectives like Grade 3 or Higher Treatment-Related Toxicity Rate in Phase 1 & 2 (which is defined as all grade 3 or higher adverse events with treatment attribution), Proportion free from [Prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) Therapy in Phase 2 (defined as the proportion of patients who do not need further prostate cancer therapy), and Median Radiographic Progression-Free Survival in Phase 1 (defined as the time from protocol treatment initiation until disease progression or death"

Answered by AI

Are we still recruiting test subjects for this experiment?

"According to the information available on clinicaltrials.gov, this particular trial is not currently looking for recruits. The last time it was updated was on November 14th, 2022. There are 1373 other trials that patients can take part in right now."

Answered by AI
~21 spots leftby Jun 2024