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

Prostatic Neoplasms Clinical Trial

Official title:

A Phase 1b Study of Abemaciclib Plus Darolutamide in Men With Metastatic Castration-Resistant Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05999968
• Other study ID #: 18714
• Secondary ID: I3Y-MC-JPEI2023-
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 12, 2024
• Est. completion date: July 2026

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: July 2026
• Est. primary completion date: February 23, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Abemaciclib
Administered orally.
• Darolutamide
Administered orally.
• LHRH agonist/antagonist
Physician's choice. Administered in accordance with the prescribing information.

Locations

Country	Name	City	State
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck	Schleswig-Holstein
Germany	Klinikum Rechts Der Isar Der Technischen Universität München	Munich	Bayern
Germany	Studienpraxis Urologie	Nürtingen	Baden-Württemberg
Spain	Hospital Infanta Cristina	Badajoz
Spain	Instituto Catalan de Oncologia - Hospital Duran i Reynals	L'Hospitalet de Llobregat	Catalunya [Cataluña]
Spain	Hospital General Universitario Gregorio Marañon	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario 12 de Octubre	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Ramón y Cajal	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
United States	Perlmutter Cancer Center at NYU Langone Hospital - Long Island	Mineola	New York
United States	Laura and Isaac Perlmutter Cancer Center	New York	New York
United States	Highlands Oncology Group	Springdale	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Bayer

Countries where clinical trial is conducted

United States,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Administration Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration	Date of first dose to study completion (approximately 32 months)
Secondary	Radiographic Progression-Free Survival (rPFS) Assessed by Investigator rPFS Assessed by Investigator	rPFS Assessed by Investigator	Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)
Secondary	Objective Response Rate (ORR): Percentage of Participants with Soft Tissue Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)	ORR: Percentage of Participants with Soft Tissue BOR of CR or PR	Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)
Secondary	Duration of Response (DoR)	DOR	Date of first documented CR or PR to radiographic disease progression or death from any cause (approximately 32 months)
Secondary	Time to Prostate Specific Antigen (PSA) Progression	Time to PSA progression	Date of first dose to the first observation of PSA progression (approximately 32 months)
Secondary	Prostate Specific Antigen (PSA) Response Rate (PSA-RR): Percentage of Participants with a PSA Decrease of at Least 50% from Baseline	PSA-RR	Date of first dose to confirmed PSA progression (approximately 32 months)
Secondary	Pharmacokinetics (PK): Mean Concentrations of Abemaciclib and its Active Metabolite(s)	PK: Mean Concentrations of Abemaciclib and its Active Metabolite(s)	Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)
Secondary	Pharmacokinetics (PK): Mean Concentrations of Darolutamide and its Active Metabolite	PK: Mean Concentrations of Darolutamide and its Active Metabolite	Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)

External Links

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