NCT02117648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3 years until next milestone

Results Posted

Study results publicly available

August 2, 2018

Completed
Last Updated

January 7, 2019

Status Verified

December 1, 2018

Enrollment Period

10 months

First QC Date

April 16, 2014

Results QC Date

October 27, 2017

Last Update Submit

December 13, 2018

Conditions

NeoplasmNeoplasm Metastasis

Keywords

advanced cancermetastatic cancer

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Abemaciclib Alone Period 1

EXPERIMENTAL

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

Drug: Abemaciclib

Abemaciclib + Clarithromycin Period 2

EXPERIMENTAL

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: AbemaciclibDrug: Clarithromycin

Abemaciclib Safety Extension

EXPERIMENTAL

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

Interventions

AbemaciclibDRUG

Administered orally

Also known as: LY2835219
Abemaciclib + Clarithromycin Period 2Abemaciclib Alone Period 1Abemaciclib Safety Extension
ClarithromycinDRUG

Administered orally

Abemaciclib + Clarithromycin Period 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No symptomatic central nervous system (CNS) malignancy or metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Accelerated Comm. Oncology Research Network (ACORN)

Memphis, Tennessee, 38119, United States

Location

The West Clinic

Memphis, Tennessee, 38120, United States

Location

Related Publications (1)

  • Gelbert LM, Cai S, Lin X, Sanchez-Martinez C, Del Prado M, Lallena MJ, Torres R, Ajamie RT, Wishart GN, Flack RS, Neubauer BL, Young J, Chan EM, Iversen P, Cronier D, Kreklau E, de Dios A. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014 Oct;32(5):825-37. doi: 10.1007/s10637-014-0120-7. Epub 2014 Jun 13.

    PMID: 24919854DERIVED

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Interventions

abemaciclibClarithromycin

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

April 1, 2014

Primary Completion

February 1, 2015

Study Completion

August 1, 2015

Last Updated

January 7, 2019

Results First Posted

August 2, 2018

Record last verified: 2018-12

Locations

US(2)