A Study of LY2835219 in Participants With Cancer

Lilly

Status and phase: Completed; Phase 1

Conditions: Neoplasm; Neoplasm Metastasis

Treatments: Drug: Clarithromycin; Drug: Abemaciclib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02117648

I3Y-MC-JPBE (Other Identifier)

15173

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

Abemaciclib Alone Period 1

Experimental group

Description:

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

Treatment:

Drug: Abemaciclib

Abemaciclib + Clarithromycin Period 2

Experimental group

Description:

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.

Treatment:

Drug: Abemaciclib

Drug: Clarithromycin

Abemaciclib Safety Extension

Experimental group

Description:

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.

Treatment:

Drug: Abemaciclib