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CompletedNCT02117648Updated Jan 7, 2019Results posted

A Study of LY2835219 in Participants With Cancer

A Phase 1 interventional study of Abemaciclib and Clarithromycin in Neoplasm and Neoplasm Metastasis, sponsored by Eli Lilly and Company. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-07.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Neoplasm
  • Neoplasm Metastasis

Keywords

  • advanced cancer
  • metastatic cancer
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's enrollment of 26 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • No symptomatic central nervous system (CNS) malignancy or metastasis
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Abemaciclib Alone Period 1

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

    Drug: Abemaciclib

  • 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 · Drug: Clarithromycin

  • 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

Interventions

  • DrugAbemaciclib

    Administered orally

    Also known as: LY2835219

  • DrugClarithromycin

    Administered orally

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Results

Posted Aug 2, 2018

Participant flow

Abemaciclib Alone Period 1
Participant flow — Abemaciclib Alone Period 1
MilestoneAbemaciclib Alone Then Abemaciclib + Clarithromycin
Started26
Received at least 1 dose of study drug26
Completed24
Not completed2
Withdrew: Withdrawal by subject1
Withdrew: Adverse event1
Abemaciclib + Clarithromycin Period 2
Participant flow — Abemaciclib + Clarithromycin Period 2
MilestoneAbemaciclib Alone Then Abemaciclib + Clarithromycin
Started24
Received at least 1 dose of study drug21
Completed20
Not completed4
Withdrew: Progressive disease1
Withdrew: Death1
Withdrew: Adverse event1
Withdrew: Withdrawal by subject1
Abemaciclib Safety-Extension Phase
Participant flow — Abemaciclib Safety-Extension Phase
MilestoneAbemaciclib Alone Then Abemaciclib + Clarithromycin
Started20
Completed0
Not completed20
Withdrew: Progressive disease12
Withdrew: Physician decision1
Withdrew: Death3
Withdrew: Withdrawal by subject2
Withdrew: Adverse event2

Outcome measures

PrimaryPharmacokinetics (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
Reported as:
Geometric mean · nanogram*hour/milliliter(mL) ng*h/mL
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of Abemaciclib
nanogram*hour/milliliter(mL) ng*h/mLAbemaciclib Period 1Abemaciclib + Clarithromycin Period 2
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of Abemaciclib2230 ± 936850 ± 66
PrimaryPK: 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
Reported as:
Geometric mean · nanogram/milliliter (ng/mL)
PK: Maximum Concentration (Cmax) of Abemaciclib
nanogram/milliliter (ng/mL)Abemaciclib Period 1Abemaciclib + Clarithromycin Period 2
PK: Maximum Concentration (Cmax) of Abemaciclib70.0 ± 7384.3 ± 55

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Abemaciclib—1/26 (3.8%)13/26 (50%)
Clarithromycin—1/24 (4.2%)7/24 (29.2%)
Abemaciclib + Clarithromycin—1/21 (4.8%)10/21 (47.6%)
Safety Extension Abemaciclib—15/20 (75%)19/20 (95%)
Most frequent serious events
Showing 10 of 34
Most frequent serious events
EventAbemaciclibClarithromycinAbemaciclib + ClarithromycinSafety Extension Abemaciclib
Small intestinal obstructionGastrointestinal disorders0/260/240/213/20
Atrial fibrillationCardiac disorders0/260/240/212/20
AnaemiaBlood and lymphatic system disorders0/260/241/211/20
Sinus tachycardiaCardiac disorders0/260/240/211/20
Abdominal painGastrointestinal disorders0/260/240/211/20
AscitesGastrointestinal disorders0/260/240/211/20
DiarrhoeaGastrointestinal disorders0/260/240/211/20
Gastrointestinal haemorrhageGastrointestinal disorders0/260/240/211/20
NauseaGastrointestinal disorders0/260/240/211/20
VomitingGastrointestinal disorders0/260/240/211/20
Most frequent other events
Showing 10 of 39
Most frequent other events
EventAbemaciclibClarithromycinAbemaciclib + ClarithromycinSafety Extension Abemaciclib
FatigueGeneral disorders1/261/241/2114/20
AnaemiaBlood and lymphatic system disorders3/260/242/2112/20
DiarrhoeaGastrointestinal disorders0/260/241/2112/20
NauseaGastrointestinal disorders3/261/241/219/20
Neutrophil count decreasedInvestigations0/261/240/219/20
Blood creatinine increasedInvestigations2/260/241/218/20
HypokalaemiaMetabolism and nutrition disorders0/260/241/218/20
VomitingGastrointestinal disorders1/262/241/217/20
HypomagnesaemiaMetabolism and nutrition disorders1/260/240/215/20
Abdominal painGastrointestinal disorders2/260/241/214/20

Baseline characteristics

Age, Customized
Age, Customized(years)Abemaciclib Then Abemaciclib + Clarithromycin
Mean60.0 ± 9.2
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Abemaciclib Then Abemaciclib + Clarithromycin
Female19
Male7
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Abemaciclib Then Abemaciclib + Clarithromycin
Hispanic or Latino1
Not Hispanic or Latino25
Unknown or Not Reported0
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Abemaciclib Then Abemaciclib + Clarithromycin
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American6
White19
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Abemaciclib Then Abemaciclib + Clarithromycin
United States26
Body Mass Index (BMI)
Body Mass Index (BMI)(kilogram/square meter (kg/m2))Abemaciclib Then Abemaciclib + Clarithromycin
Mean27.62 ± 6.04
Eastern Cooperative Oncology Group (ECOG) Scale
Eastern Cooperative Oncology Group (ECOG) Scale(participants)Abemaciclib Then Abemaciclib + Clarithromycin
ECOG= 018
ECOG= 18
08

Study locations

2 sites
  • Accelerated Comm. Oncology Research Network (ACORN)
    Memphis, Tennessee 38119, United States
  • The West Clinic
    Memphis, Tennessee 38120, United States
09

References and documents

Publications

  • 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. PubMed 24919854 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02117648
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Apr 21, 2014
Start date
Apr 2014
Primary completion
Feb 2015
Completion
Aug 2015
Results posted
Aug 2, 2018
Last update
Jan 7, 2019

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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