A Phase 1 Study of Abemaciclib in Combination With Other Anti-Cancer Therapy in Japanese Patients With Advanced Cancer

Eli Lilly and Company2 sites in 1 country6 target enrollmentDecember 20, 2019

ConditionsAdvanced Cancer

InterventionsAbemaciclib Abiraterone Acetate Prednisolone

DrugsAbemaciclib Abiraterone Acetate Prednisolone

Overview

Phase: Phase 1
Intervention: Abemaciclib
Conditions: Advanced Cancer
Sponsor: Eli Lilly and Company
Enrollment: 6
Locations: 2
Primary Endpoint: Number of Participants with Dose Limiting Toxicities (DLTs)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to see if the study drug abemaciclib in combination with other anti-cancer therapies is safe in Japanese participants with advanced cancer.

Registry

clinicaltrials.gov

Start Date

December 20, 2019

End Date

August 30, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant with histologically confirmed adenocarcinoma of the prostate.
•Participant with metastatic disease documented by positive bone scan and/or measurable soft tissue metastatic lesions by computed tomography (CT) or magnetic resonance imagining (MRI).
•Participant who has serum testosterone level is ≤1.73 nanomoles per liter (nmol/L) (50 nanograms per deciliter).
•Participant who has progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy.
•Participant with adequate organ function.
•Participant with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Exclusion Criteria

•Participant who was treated with cytochrome P450 (CYP)17 inhibitors (including abiraterone acetate, TAK-700, TOK-001, and ketoconazole).
•Participant who was treated with abemaciclib or any cyclin dependent kinase 4 and 6 (CDK4 and 6) inhibitors.
•Participant who has prior cytotoxic chemotherapy for metastatic castration-resistant prostate cancer (mCRPC), prior radiopharmaceuticals for prostate cancer (PCa), or prior sipuleucel-T.
•Participant who has gastrointestinal disorder affecting absorption or inability to swallow large pills.
•Participant who has clinically active or chronic liver disease, moderate/severe hepatic impairment, ascites, or bleeding disorders secondary to hepatic dysfunction.
•Participant who has known or suspected central nervous system metastatic disease.
•Participant who was treated with drugs known to be strong inhibitors, or strong or moderate inducers of cytochrome P450 3A4 (CYP3A4) and the treatment cannot be discontinued or switched prior to starting study treatment.

Arms & Interventions

Abemaciclib + Abiraterone Acetate + Prednisolone

Abemaciclib, abiraterone acetate and prednisolone given orally.

Intervention: Abemaciclib

Abemaciclib + Abiraterone Acetate + Prednisolone

Abemaciclib, abiraterone acetate and prednisolone given orally.

Intervention: Abiraterone Acetate

Abemaciclib + Abiraterone Acetate + Prednisolone

Abemaciclib, abiraterone acetate and prednisolone given orally.

Intervention: Prednisolone

Outcomes

Primary Outcomes

Number of Participants with Dose Limiting Toxicities (DLTs)

Time Frame: Baseline through Cycle 1 (28 Day Cycle)

Number of Participants with DLTs

Secondary Outcomes

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone(Predose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles))
PK: Maximum Concentration (Cmax) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone(Predose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles))