Prostate Cancer Clinical Trial

Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment

Summary

The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with darolutamide to participants with prostate cancer that has spread after initial treatment. Participation may last up to 32 months.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate.

Metastatic castration-resistant prostate cancer evidenced by:

Prostate-specific antigen (PSA) or radiographic progression despite castrate levels of testosterone
At least 1 bone metastasis on bone scan and/or 1 soft tissue metastasis on computed tomography/magnetic resonance imaging (CT/MRI)
Participants who have not undergone bilateral orchiectomy must continue luteinizing-hormone-releasing hormone (LHRH) agonists/antagonists throughout the study.
Have adequate organ function.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

Exclusion Criteria:

Prior treatment with cyclin-dependent kinase 4 and 6 (CDK4 and CDK6) inhibitors or darolutamide.
Prior systemic therapy for metastatic castration-resistant prostate cancer(mCRPC) with cytotoxic chemotherapy, PARP inhibitors, novel hormonal agents (NHAs) (enzalutamide, apalutamide, and abiraterone), and radiopharmaceuticals.
Serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
Clinically significant heart disease as evidenced by myocardial infarction, arterial thrombotic events, severe or unstable angina, or congestive heart failure (New York Heart Association Class III or IV) within 6 months of assignment to treatment.

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT05999968

Recruitment Status:

Not yet recruiting

Sponsor:

Eli Lilly and Company

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 10 Locations for this study

See Locations Near You

Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola New York, 11501, United States More Info
Contact
212-731-6366
David R Wise
Principal Investigator
Laura and Isaac Perlmutter Cancer Center
New York New York, 10016, United States More Info
Contact
212-731-6366
David R Wise
Principal Investigator
Studienpraxis Urologie
Nürtingen Baden-Württemberg, 72622, Germany More Info
Contact
4915201622246
Tilman Todenhöfer
Principal Investigator
Universitaetsklinikum Hamburg-Eppendorf
Hamburg , 20246, Germany More Info
Contact
040741057673
Gunhild Von Amsberg
Principal Investigator
Instituto Catalan de Oncologia - Hospital Duran i Reynals
L'Hospitalet de Llobregat Catalunya [Cataluña], 8907, Spain More Info
Contact
34932607744
Josep Maria Piulats Rodriguez
Principal Investigator
Hospital General Universitario Gregorio Marañon
Madrid Madrid, Comunidad De, 28009, Spain More Info
Contact
34914265238
Jose Angel Arranz Arija
Principal Investigator
Hospital Universitario Ramón y Cajal
Madrid Madrid, Comunidad De, 28034, Spain More Info
Contact
349133682
Teresa Alonso Gordoa
Principal Investigator
Hospital Universitario 12 de Octubre
Madrid Madrid, Comunidad De, 28041, Spain More Info
Contact
00349139083
Daniel Castellano Gauna
Principal Investigator
Hospital Infanta Cristina
Badajoz , 06006, Spain More Info
Contact
924218040
Marta Gonzalez Cordero
Principal Investigator
Hospital Universitario Virgen Del Rocio
Sevilla , 41013, Spain More Info
JULIA Martinez Perez
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT05999968

Recruitment Status:

Not yet recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.