A Study of LY2835219 in Participants With Cancer

Phase 1

Completed

• Conditions: Neoplasm; Neoplasm Metastasis
• Interventions: Drug: Abemaciclib; Drug: Clarithromycin

• Registration Number: NCT02117648
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Primary Completion: 2015-02
• Study Completion: 2015-08
• Results First Submitted: 2017-10-27
• Results First Submitted QC: 2017-10-27
• Results First Posted: 2018-08-02
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-13
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Abemaciclib Alone Period 1	Abemaciclib	50 mg single oral dose of Abemaciclib was administered in Period 1 Day 1.
Abemaciclib + Clarithromycin Period 2	Clarithromycin	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.
Abemaciclib + Clarithromycin Period 2	Abemaciclib	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.
Abemaciclib Safety Extension	Abemaciclib	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Accelerated Comm. Oncology Research Network (ACORN); 🇺🇸 Memphis, Tennessee, United States

The West Clinic; 🇺🇸 Memphis, Tennessee, United States