A Study of LY2835219 in Participants With Cancer

December 13, 2018 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
      • Memphis, Tennessee, United States, 38119
        • Accelerated Comm. Oncology Research Network (ACORN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abemaciclib Alone Period 1
50 mg single oral dose of Abemaciclib was administered in Period 1 Day 1.
Drug: Abemaciclib
Administered orally
Other Names:
  • LY2835219
Experimental: 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.
Drug: Abemaciclib
Administered orally
Other Names:
  • LY2835219
Drug: Clarithromycin
Administered orally
Experimental: 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.
Drug: Abemaciclib
Administered orally
Other Names:
  • LY2835219

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of Abemaciclib
Time Frame: 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
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

December 13, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15173
  • I3Y-MC-JPBE (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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