Clinical trial NCT05999968: Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
Official title: A Phase 1b Study of Abemaciclib Plus Darolutamide in Men With Metastatic Castration-Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Prostatic Neoplasms
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2023-08-21
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Date of first dose to study completion (approximately 32 months)
Secondary outcomes:
measure: Radiographic Progression-Free Survival (rPFS) Assessed by Investigator rPFS Assessed by Investigator
timeFrame: Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)
measure: Objective Response Rate (ORR): Percentage of Participants with Soft Tissue Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
timeFrame: Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)
measure: Duration of Response (DoR)
timeFrame: Date of first documented CR or PR to radiographic disease progression or death from any cause (approximately 32 months)
measure: Time to Prostate Specific Antigen (PSA) Progression
timeFrame: Date of first dose to the first observation of PSA progression (approximately 32 months)
measure: Prostate Specific Antigen (PSA) Response Rate (PSA-RR): Percentage of Participants with a PSA Decrease of at Least 50% from Baseline
timeFrame: Date of first dose to confirmed PSA progression (approximately 32 months)
measure: Pharmacokinetics (PK): Mean Concentrations of Abemaciclib and its Active Metabolite(s)
timeFrame: Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)
measure: Pharmacokinetics (PK): Mean Concentrations of Darolutamide and its Active Metabolite
timeFrame: Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Mineola
country: United States
facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center
state: New York
city: Nürtingen
country: Germany
facility: Studienpraxis Urologie
state: Baden-Württemberg
city: Munich
country: Germany
facility: Klinikum Rechts Der Isar Der Technischen Universität München
state: Bayern
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: L'Hospitalet de Llobregat
country: Spain
facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals
state: Catalunya [Cataluña]
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Madrid, Comunidad De
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: