A Study of LY2835219 in Participants With Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-08-31

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.

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Detailed Description

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Conditions

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Neoplasm Neoplasm Metastasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Abemaciclib Alone Period 1

50 mg single oral dose of Abemaciclib was administered in Period 1 Day 1.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered orally

Abemaciclib + Clarithromycin Period 2

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.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered orally

Clarithromycin

Intervention Type DRUG

Administered orally

Abemaciclib Safety Extension

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.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered orally

Interventions

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Abemaciclib

Administered orally

Intervention Type DRUG

Clarithromycin

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY2835219

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