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A Study of LY2835219 in Participants With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02117648
Recruitment Status : Completed
First Posted : April 21, 2014
Results First Posted : August 2, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Neoplasm
Neoplasm Metastasis
Interventions Drug: Abemaciclib
Drug: Clarithromycin
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abemaciclib Alone Then Abemaciclib + Clarithromycin
Hide Arm/Group Description 50 mg single oral dose of Abemaciclib was administered on Period 1 Day 1 and on Period 2 Day 5. Clarithromycin 500 milligram (mg) orally twice daily for 12 days. Clarithromycin dosing continued for 7 days following the single dose of 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.
Period Title: Abemaciclib Alone Period 1
Started 26
Received at Least 1 Dose of Study Drug 26
Completed 24
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Adverse Event             1
Period Title: Abemaciclib + Clarithromycin Period 2
Started 24
Received at Least 1 Dose of Study Drug 21
Completed 20
Not Completed 4
Reason Not Completed
Progressive Disease             1
Death             1
Adverse Event             1
Withdrawal by Subject             1
Period Title: Abemaciclib Safety-Extension Phase
Started 20
Completed 0
Not Completed 20
Reason Not Completed
Progressive Disease             12
Physician Decision             1
Death             3
Withdrawal by Subject             2
Adverse Event             2
Arm/Group Title Abemaciclib Then Abemaciclib + Clarithromycin
Hide Arm/Group Description 50 mg single oral dose of Abemaciclib was administered on Period 1 Day 1 and on Period 2 Day 5. Clarithromycin 500 mg orally twice daily for 12 days. Clarithromycin dosing continued for 7 days following the single dose of Abemaciclib. After completing Period 2, eligible participants continued to receive 200 mg Abemaciclib Q12H on a 28-day cycle in a safety-extension phase until discontinuation criteria were met.
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
60.0  (9.2)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female 19
Male 7
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Hispanic or Latino 1
Not Hispanic or Latino 25
Unknown or Not Reported 0
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
American Indian or Alaska Native 0
Asian 1
Native Hawaiian or Other Pacific Islander 0
Black or African American 6
White 19
More than one race 0
Unknown or Not Reported 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 26 participants
26
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram/square meter (kg/m2)
Number Analyzed 26 participants
27.62  (6.04)
Eastern Cooperative Oncology Group (ECOG) Scale   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
ECOG= 0 18
ECOG= 1 8
[1]
Measure Description:

ECOG 0 = Fully active, able to carry on all predisease performance without restriction

ECOG 1 = Restricted in physically strenuous activity but ambulatory and able to carry out performance of a light or sedentary nature, for example, light housework, office work

1.Primary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of Abemaciclib
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug and had evaluable AUC(0-∞) data.
Arm/Group Title Abemaciclib Period 1 Abemaciclib + Clarithromycin Period 2
Hide Arm/Group Description:
50 mg single oral dose of Abemaciclib was administered in Period 1 Day 1.
Starting on Period 2 Day 1, Clarithromycin 500 mg orally twice daily for 12 days. Single oral dose of Abemaciclib on Period 2 Day 5. Clarithromycin dosing continued for 7 days following the single dose of Abemaciclib.
Overall Number of Participants Analyzed 26 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour/milliliter(mL) ng*h/mL
2230
(93%)
6850
(66%)
2.Primary Outcome
Title PK: Maximum Concentration (Cmax) of Abemaciclib
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug and had evaluable cmax data.
Arm/Group Title Abemaciclib Period 1 Abemaciclib + Clarithromycin Period 2
Hide Arm/Group Description:
50 mg single oral dose of Abemaciclib was administered in Period 1 Day 1.
Starting on Period 2 Day 1, Clarithromycin 500 mg orally twice daily for 12 days. Single oral dose of Abemaciclib on Period 2 Day 5. Clarithromycin dosing continued for 7 days following the single dose of Abemaciclib.
Overall Number of Participants Analyzed 26 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram/milliliter (ng/mL)
70.0
(73%)
84.3
(55%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abemaciclib Clarithromycin Abemaciclib + Clarithromycin Safety Extension Abemaciclib
Hide Arm/Group Description 50 mg single oral dose of Abemaciclib was administered in Period 1 Day 1. Clarithromycin 500 mg orally twice daily for 12 days Clarithromycin 500 mg orally twice daily for 12 days. Single oral dose of Abemaciclib on Period 2 Day 5 . Clarithromycin dosing continued for 7 days following the single dose of Abemaciclib. After completing Period 2, eligible participants continued to receive 200 mg Abemaciclib Q12H on a 28-day cycle in a safety-extension phase until discontinuation criteria were met.
All-Cause Mortality
Abemaciclib Clarithromycin Abemaciclib + Clarithromycin Safety Extension Abemaciclib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Abemaciclib Clarithromycin Abemaciclib + Clarithromycin Safety Extension Abemaciclib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/26 (3.85%)      1/24 (4.17%)      1/21 (4.76%)      15/20 (75.00%)    
Blood and lymphatic system disorders         
Anaemia  1  0/26 (0.00%)  0 0/24 (0.00%)  0 1/21 (4.76%)  1 1/20 (5.00%)  1
Cardiac disorders         
Atrial fibrillation  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 2/20 (10.00%)  2
Sinus tachycardia  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Gastrointestinal disorders         
Abdominal pain  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Ascites  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Diarrhoea  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Gastrointestinal haemorrhage  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Nausea  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Small intestinal obstruction  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 3/20 (15.00%)  3
Vomiting  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
General disorders         
Asthenia  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Pyrexia  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Infections and infestations         
Cellulitis  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Sepsis  1  0/26 (0.00%)  0 0/24 (0.00%)  0 1/21 (4.76%)  1 0/20 (0.00%)  0
Staphylococcal sepsis  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Urinary tract infection  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Injury, poisoning and procedural complications         
Fall  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Metabolism and nutrition disorders         
Dehydration  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  2
Hypoglycaemia  1  0/26 (0.00%)  0 1/24 (4.17%)  1 0/21 (0.00%)  0 1/20 (5.00%)  1
Hypokalaemia  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders         
Musculoskeletal pain  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Malignant neoplasm progression  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Plasma cell myeloma  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Nervous system disorders         
Convulsion  1  1/26 (3.85%)  1 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Syncope  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Renal and urinary disorders         
Haematuria  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Hydronephrosis  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Dyspnoea  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Pleural effusion  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Pneumothorax  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Pulmonary embolism  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Vascular disorders         
Deep vein thrombosis  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Hypotension  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abemaciclib Clarithromycin Abemaciclib + Clarithromycin Safety Extension Abemaciclib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/26 (50.00%)      7/24 (29.17%)      10/21 (47.62%)      19/20 (95.00%)    
Blood and lymphatic system disorders         
Anaemia  1  3/26 (11.54%)  3 0/24 (0.00%)  0 2/21 (9.52%)  2 12/20 (60.00%)  15
Cardiac disorders         
Tachycardia  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 2/20 (10.00%)  2
Gastrointestinal disorders         
Abdominal pain  1  2/26 (7.69%)  2 0/24 (0.00%)  0 1/21 (4.76%)  1 4/20 (20.00%)  6
Constipation  1  1/26 (3.85%)  1 0/24 (0.00%)  0 0/21 (0.00%)  0 3/20 (15.00%)  3
Diarrhoea  1  0/26 (0.00%)  0 0/24 (0.00%)  0 1/21 (4.76%)  1 12/20 (60.00%)  17
Dry mouth  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 2/20 (10.00%)  2
Nausea  1  3/26 (11.54%)  3 1/24 (4.17%)  1 1/21 (4.76%)  1 9/20 (45.00%)  12
Stomatitis  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 3/20 (15.00%)  3
Vomiting  1  1/26 (3.85%)  1 2/24 (8.33%)  2 1/21 (4.76%)  1 7/20 (35.00%)  11
General disorders         
Disease progression  1  0/26 (0.00%)  0 1/24 (4.17%)  1 0/21 (0.00%)  0 2/20 (10.00%)  2
Fatigue  1  1/26 (3.85%)  1 1/24 (4.17%)  1 1/21 (4.76%)  1 14/20 (70.00%)  19
Non-cardiac chest pain  1  1/26 (3.85%)  1 0/24 (0.00%)  0 0/21 (0.00%)  0 2/20 (10.00%)  2
Oedema peripheral  1  2/26 (7.69%)  2 1/24 (4.17%)  1 2/21 (9.52%)  2 1/20 (5.00%)  1
Pyrexia  1  1/26 (3.85%)  1 0/24 (0.00%)  0 0/21 (0.00%)  0 3/20 (15.00%)  3
Infections and infestations         
Urinary tract infection  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 3/20 (15.00%)  4
Vaginal infection  1  0/19 (0.00%)  0 0/19 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1
Investigations         
Blood creatinine increased  1  2/26 (7.69%)  2 0/24 (0.00%)  0 1/21 (4.76%)  1 8/20 (40.00%)  10
Neutrophil count decreased  1  0/26 (0.00%)  0 1/24 (4.17%)  1 0/21 (0.00%)  0 9/20 (45.00%)  17
Platelet count decreased  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 3/20 (15.00%)  4
Metabolism and nutrition disorders         
Decreased appetite  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 4/20 (20.00%)  4
Dehydration  1  1/26 (3.85%)  1 0/24 (0.00%)  0 0/21 (0.00%)  0 2/20 (10.00%)  4
Hypercalcaemia  1  0/26 (0.00%)  0 0/24 (0.00%)  0 1/21 (4.76%)  1 3/20 (15.00%)  6
Hyperkalaemia  1  2/26 (7.69%)  2 0/24 (0.00%)  0 0/21 (0.00%)  0 0/20 (0.00%)  0
Hyperuricaemia  1  1/26 (3.85%)  1 1/24 (4.17%)  1 1/21 (4.76%)  1 3/20 (15.00%)  4
Hypocalcaemia  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 2/20 (10.00%)  2
Hypokalaemia  1  0/26 (0.00%)  0 0/24 (0.00%)  0 1/21 (4.76%)  1 8/20 (40.00%)  11
Hypomagnesaemia  1  1/26 (3.85%)  1 0/24 (0.00%)  0 0/21 (0.00%)  0 5/20 (25.00%)  7
Hyponatraemia  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 4/20 (20.00%)  4
Hypophosphataemia  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 2/20 (10.00%)  2
Nervous system disorders         
Dizziness  1  1/26 (3.85%)  1 0/24 (0.00%)  0 0/21 (0.00%)  0 2/20 (10.00%)  2
Dysgeusia  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 3/20 (15.00%)  3
Headache  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 4/20 (20.00%)  4
Psychiatric disorders         
Anxiety  1  1/26 (3.85%)  1 0/24 (0.00%)  0 0/21 (0.00%)  0 2/20 (10.00%)  2
Renal and urinary disorders         
Cystitis noninfective  1  1/26 (3.85%)  1 0/24 (0.00%)  0 0/21 (0.00%)  0 2/20 (10.00%)  2
Dysuria  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 2/20 (10.00%)  2
Reproductive system and breast disorders         
Vaginal haemorrhage  1  0/19 (0.00%)  0 0/19 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  2/26 (7.69%)  2 0/24 (0.00%)  0 2/21 (9.52%)  2 1/20 (5.00%)  1
Skin and subcutaneous tissue disorders         
Pruritus  1  0/26 (0.00%)  0 0/24 (0.00%)  0 0/21 (0.00%)  0 2/20 (10.00%)  2
Vascular disorders         
Hypotension  1  1/26 (3.85%)  1 0/24 (0.00%)  0 0/21 (0.00%)  0 4/20 (20.00%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02117648     History of Changes
Other Study ID Numbers: 15173
I3Y-MC-JPBE ( Other Identifier: Eli Lilly and Company )
First Submitted: April 16, 2014
First Posted: April 21, 2014
Results First Submitted: October 27, 2017
Results First Posted: August 2, 2018
Last Update Posted: January 7, 2019