A Study of LY2835219 in Participants With Cancer

Study Overview
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Brief Summary
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The purpose of this study is to assess how the body handles Abemaciclib when it is given with another drug called clarithromycin. The study doctor will measure the amount of Abemaciclib that is absorbed into the blood stream and the time that it takes to remove Abemaciclib from the body. The safety and tolerability of these drugs will be studied. Each participant will complete 2 study periods in fixed order. After screening, Period 1 will last approximately 8 days and Period 2 will last approximately 15 days. Participants who complete Period 2 may continue to receive Abemaciclib in 28-day cycles until discontinuation criteria are met.

Official Title
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Effects of CYP3A Inhibition by Clarithromycin on the Pharmacokinetics of LY2835219 and Its Metabolites in Cancer Patients

Conditions
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Neoplasm, Neoplasm Metastasis

Intervention / Treatment
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* Drug: Abemaciclib
* Drug: Clarithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have histological or cytological evidence of cancer (solid tumors) that is advanced and/or metastatic Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale Exclusion Criteria: No symptomatic central nervous system (CNS) malignancy or metastasis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abemaciclib Alone Period 1<br>50 mg single oral dose of Abemaciclib was administered in Period 1 Day 1. | Drug: Abemaciclib<br>* Administered orally<br>* Other names: LY2835219;|
| Experimental: Abemaciclib + Clarithromycin Period 2<br>Clarithromycin 500 milligram (mg) orally twice daily for 12 days. Single oral dose of Abemaciclib 50 mg on Period 2 Day 5. Clarithromycin dosing continued for 7 days following the single dose of Abemaciclib. | Drug: Abemaciclib<br>* Administered orally<br>* Other names: LY2835219;Drug: Clarithromycin<br>* Administered orally<br>|
| Experimental: Abemaciclib Safety Extension<br>After completing Period 2, eligible participants continued to receive 200 mg Abemaciclib every 12 hours (Q12H) on a 28-day cycle in a safety-extension phase until discontinuation criteria were met. | Drug: Abemaciclib<br>* Administered orally<br>* Other names: LY2835219;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of Abemaciclib |  | Period 1: Predose; 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168hr, Period 2: 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240hr Post dose | 
| PK: Maximum Concentration (Cmax) of Abemaciclib |  | Period 1: Predose; 1, 2, 4, 6, 8, 10, 24, 48, 72, 96,120,144,168hr, Period 2: 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240hr Post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced cancer, metastatic cancer