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

Lilly

Status and phase: Active, not recruiting; Phase 1

Conditions: Prostatic Neoplasms

Treatments: Drug: LHRH agonist/antagonist; Drug: Abemaciclib; Drug: Darolutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05999968

U1111-1294-1466 (Registry Identifier)

18714

I3Y-MC-JPEI (Other Identifier)

2023-503919-15-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Abemaciclib + Darolutamide

Experimental group

Description:

Abemaciclib plus (+) darolutamide. Participants who have not undergone bilateral orchiectomy are required to continue background androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist/antagonist throughout the study.

Treatment:

Drug: Darolutamide

Drug: Abemaciclib

Drug: LHRH agonist/antagonist