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Trial record 50 of 197 for:    Oral Cancer | ( Map: Mexico )

A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer (MONARCH 3)

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: NCT02246621
Recruitment Status : Active, not recruiting
First Posted : September 23, 2014
Results First Posted : March 23, 2018
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Abemaciclib
Drug: Anastrozole
Drug: Letrozole
Drug: Placebo
Enrollment 493
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abemaciclib + NSAI (Nonsteroidal Aromatase Inhibitors) Placebo + NSAI
Hide Arm/Group Description 150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles). Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Period Title: Overall Study
Started 328 165
Received At Least One Dose of Study Drug 326 162
Completed 32 17
Not Completed 296 148
Reason Not Completed
Withdrawal by Subject             36             14
Lost to Follow-up             3             1
On Study Treatment/ Follow Up             257             133
Arm/Group Title Abemaciclib + NSAI Placebo + NSAI Total
Hide Arm/Group Description 150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles). Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles). Total of all reporting groups
Overall Number of Baseline Participants 328 165 493
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 328 participants 165 participants 493 participants
63.13  (9.92) 62.92  (9.96) 63.05  (9.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants 165 participants 493 participants
Female 328 165 493
Male 0 0 0
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants 165 participants 493 participants
Hispanic or Latino 32 12 44
Not Hispanic or Latino 230 125 355
Unknown or Not Reported 66 28 94
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants 165 participants 493 participants
American Indian or Alaska Native 4 3 7
Asian 103 45 148
Native Hawaiian or Other Pacific Islander 0 1 1
Black or African American 5 3 8
White 186 102 288
More than one race 2 0 2
Unknown or Not Reported 28 11 39
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants 165 participants 493 participants
Australia 9 6 15
Austria 10 3 13
Belgium 14 7 21
Canada 14 11 25
Germany 11 5 16
Spain 16 14 30
France 30 11 41
United Kingdom 7 2 9
Greece 0 1 1
Israel 28 19 47
Italy 11 11 22
Japan 38 15 53
South Korea 41 18 59
Mexico 22 7 29
Netherlands 2 4 6
New Zealand 1 0 1
Russia 13 6 19
Slovakia 2 0 2
Sweden 3 1 4
Turkey 9 3 12
Taiwan 23 9 32
United States 24 12 36
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Time Frame Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Abemaciclib + NSAI Placebo + NSAI
Hide Arm/Group Description:
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed 328 165
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
14.73
(11.11 to 17.46)
[1]
Median of PFS not reached due to number of events not yet attained. Anticipated reporting date: April 2018
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abemaciclib + NSAI, Placebo + NSAI
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .000021
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.543
Confidence Interval (2-Sided) 95%
0.409 to 0.723
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Time Frame Randomization to Progressive Disease or Death Due to Any Cause (Estimated Up to 82 Months)
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Hide Description ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
Time Frame Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Abemaciclib + NSAI Placebo + NSAI
Hide Arm/Group Description:
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed 328 165
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
48.2
(42.8 to 53.6)
34.5
(27.3 to 41.8)
4.Secondary Outcome
Title Duration of Response (DoR)
Hide Description DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.
Time Frame CR or PR to Disease Progression or Death Due to Any Cause (Up to 26 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and first evidence of CR or PR as assessed by the investigator.
Arm/Group Title Abemaciclib + NSAI Placebo + NSAI
Hide Arm/Group Description:
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed 158 57
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
14.1 [1] 
(11.08 to NA)
[1]
DoR not reached due to number of events not yet attained. Anticipated reporting date: April 2018
5.Secondary Outcome
Title Percentage of Participants With CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])
Hide Description DCR was the percentage of participants with a best overall response of CR, PR, or SD as per response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Time Frame Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Abemaciclib + NSAI Placebo + NSAI
Hide Arm/Group Description:
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed 328 165
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
88.7
(85.3 to 92.1)
86.7
(81.5 to 91.9)
6.Secondary Outcome
Title Percentage of Participants With Tumor Response of SD for at Least 6 Months, PR, or CR (Clinical Benefit Rate [CBR])
Hide Description CBR defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months / number of participants enrolled) * 100.
Time Frame Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Abemaciclib + NSAI Placebo + NSAI
Hide Arm/Group Description:
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed 328 165
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
78.0
(73.6 to 82.5)
71.5
(64.6 to 78.4)
7.Secondary Outcome
Title Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores
Hide Description EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. Functional scale options are defined on a 7-point scale ranging from 1, "Very poor" to 7, "Excellent". A linear transformation is applied to standardize the raw scores to range between 0 and 100. For functional domains and global health status, higher scores represent a better level of functioning. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate. EORTC change score definitions are described in Cocks et al, (2012) and differ for each item. Small changes are generally defined as at least a 3, 4 or 5 point change from baseline.
Time Frame Baseline, End of Study (Estimated up to 34 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Efficacy data were analyzed based upon the interim analysis as described in the study design. This outcome measure is from baseline to end of study and will be analyzed and reported after the end of study data are collected. Anticipated reporting December 2018.
Arm/Group Title Abemaciclib + NSAI Placebo + NSAI
Hide Arm/Group Description:
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
Hide Description

EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. Symptom scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much." A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.

EORTC change score definitions are described in Cocks et al, (2012) and differ according to each item. Small changes are generally defined as at least a 3, 4 or 5 point change from baseline

Time Frame Baseline, End of Study (Estimated up to 34 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Efficacy data were analyzed based upon the interim analysis as described in the study design. This outcome measure is from baseline to end of study and will be analyzed and reported after the end of study data are collected. Anticipated reporting December 2018.
Arm/Group Title Abemaciclib + NSAI Placebo + NSAI
Hide Arm/Group Description:
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
Hide Description The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much" . All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning.
Time Frame Baseline, End of Study (Estimated up to 34 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Efficacy data were analyzed based upon the interim analysis as described in the study design. This outcome measure is from baseline to end of study and will be analyzed and reported after the end of study data are collected. Anticipated reporting December 2018.
Arm/Group Title Abemaciclib + NSAI Placebo + NSAI
Hide Arm/Group Description:
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Change From Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L)
Hide Description

The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts.The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a five level scale (no problem, slight problem, moderate problem, severe problem and extreme problem) with higher levels indicating greater severity/ impairment. Published weights are available that allow for the creation of a single summary score called the EQ-5D index that ranges from 0 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health.

Minimally important differences in the EQ-5D index score are 0.06 or greater in cancer patients, per Pickard et al (2007).

Time Frame Baseline, End of Study (Estimated up to 34 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Efficacy data were analyzed based upon the interim analysis as described in the study design. This outcome measure is from baseline to end of study and will be analyzed and reported after the end of study data are collected. Anticipated reporting December 2018.
Arm/Group Title Abemaciclib + NSAI Placebo + NSAI
Hide Arm/Group Description:
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Change From Baseline to End of Study in Health Status on the EuroQol-5D 5L Visual Analog Scale (VAS) Scores Scale
Hide Description

The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

Minimally important differences in the EQ-5D VAS score are 7 or greater in cancer patients, per Pickard et al (2007).

Time Frame Baseline, End of Study (Estimated up to 34 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. Efficacy data were analyzed based upon the interim analysis as described in the study design. This outcome measure is from baseline to end of study and will be analyzed and reported after the end of study data are collected. Anticipated reporting December 2018.
Arm/Group Title Abemaciclib + NSAI Placebo + NSAI
Hide Arm/Group Description:
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Abemaciclib and Its Metabolites M2 and M20
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with evaluable PK data.
Arm/Group Title Abemaciclib + NSAI
Hide Arm/Group Description:
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed 322
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hours/milliliter (ng*h/mL)
Abemaciclib
3360
(36.6%)
M2
1290
(75.8%)
M20
2300
(74.4%)
13.Secondary Outcome
Title PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with evaluable PK data.
Arm/Group Title Abemaciclib + NSAI
Hide Arm/Group Description:
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed 322
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: liters/hour (L/h)
Abemaciclib
23.0
(26.7%)
M2
21.6
(50.4%)
M20
26.0
(46.4%)
Time Frame Entire study; up to 34 months
Adverse Event Reporting Description All randomized participants who received at least one dose of study drug.
 
Arm/Group Title Abemaciclib + NSAI Placebo + NSAI
Hide Arm/Group Description 150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles). Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
All-Cause Mortality
Abemaciclib + NSAI Placebo + NSAI
Affected / at Risk (%) Affected / at Risk (%)
Total   32/327 (9.79%)      16/161 (9.94%)    
Show Serious Adverse Events Hide Serious Adverse Events
Abemaciclib + NSAI Placebo + NSAI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   90/327 (27.52%)      24/161 (14.91%)    
Blood and lymphatic system disorders     
Anaemia  1  5/327 (1.53%)  5 0/161 (0.00%)  0
Disseminated intravascular coagulation  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Neutropenia  1  2/327 (0.61%)  2 0/161 (0.00%)  0
Cardiac disorders     
Angina pectoris  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Atrial fibrillation  1  2/327 (0.61%)  2 0/161 (0.00%)  0
Atrial tachycardia  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Cardiac failure  1  2/327 (0.61%)  2 0/161 (0.00%)  0
Myocardial infarction  1  0/327 (0.00%)  0 1/161 (0.62%)  1
Pericardial effusion  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Stress cardiomyopathy  1  0/327 (0.00%)  0 1/161 (0.62%)  1
Supraventricular tachycardia  1  2/327 (0.61%)  2 0/161 (0.00%)  0
Ventricular arrhythmia  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  0/327 (0.00%)  0 1/161 (0.62%)  1
Vertigo positional  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  0/327 (0.00%)  0 1/161 (0.62%)  1
Colitis  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Constipation  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Diarrhoea  1  5/327 (1.53%)  7 0/161 (0.00%)  0
Enterocolitis  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Food poisoning  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Ileus  1  1/327 (0.31%)  1 1/161 (0.62%)  1
Nausea  1  1/327 (0.31%)  2 0/161 (0.00%)  0
Oesophagitis  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Rectal haemorrhage  1  1/327 (0.31%)  1 1/161 (0.62%)  1
Vomiting  1  2/327 (0.61%)  3 2/161 (1.24%)  2
General disorders     
General physical health deterioration  1  2/327 (0.61%)  2 1/161 (0.62%)  2
Pyrexia  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Sudden death  1  0/327 (0.00%)  0 1/161 (0.62%)  1
Ulcer haemorrhage  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  2/327 (0.61%)  2 0/161 (0.00%)  0
Hepatitis toxic  1  1/327 (0.31%)  2 0/161 (0.00%)  0
Immune system disorders     
Anaphylactic reaction  1  0/327 (0.00%)  0 1/161 (0.62%)  1
Infections and infestations     
Cellulitis  1  2/327 (0.61%)  2 0/161 (0.00%)  0
Erysipelas  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Gastroenteritis  1  0/327 (0.00%)  0 1/161 (0.62%)  1
Lung infection  1  9/327 (2.75%)  12 0/161 (0.00%)  0
Mastitis  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Periodontitis  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Sepsis  1  1/327 (0.31%)  1 1/161 (0.62%)  1
Skin infection  1  1/327 (0.31%)  2 1/161 (0.62%)  1
Urinary tract infection  1  3/327 (0.92%)  3 1/161 (0.62%)  1
Wound infection  1  0/327 (0.00%)  0 1/161 (0.62%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Fall  1  1/327 (0.31%)  1 1/161 (0.62%)  1
Fracture  1  2/327 (0.61%)  2 1/161 (0.62%)  1
Hip fracture  1  3/327 (0.92%)  3 0/161 (0.00%)  0
Spinal fracture  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Wound dehiscence  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Wrist fracture  1  0/327 (0.00%)  0 1/161 (0.62%)  1
Investigations     
Alanine aminotransferase increased  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Aspartate aminotransferase increased  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Blood bilirubin increased  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Blood creatinine increased  1  3/327 (0.92%)  3 0/161 (0.00%)  0
Metabolism and nutrition disorders     
Cachexia  1  0/327 (0.00%)  0 1/161 (0.62%)  1
Decreased appetite  1  0/327 (0.00%)  0 1/161 (0.62%)  1
Dehydration  1  4/327 (1.22%)  5 2/161 (1.24%)  2
Hypercalcaemia  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Hyperkalaemia  1  2/327 (0.61%)  2 0/161 (0.00%)  0
Hyponatraemia  1  2/327 (0.61%)  3 0/161 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Arthritis  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Back pain  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Bone pain  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Breast cancer metastatic  1  0/327 (0.00%)  0 1/161 (0.62%)  1
Tumour haemorrhage  1  0/327 (0.00%)  0 1/161 (0.62%)  1
Nervous system disorders     
Cerebral ischaemia  1  1/327 (0.31%)  2 0/161 (0.00%)  0
Cerebrovascular accident  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Presyncope  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Spinal cord compression  1  0/327 (0.00%)  0 1/161 (0.62%)  2
Syncope  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Transient ischaemic attack  1  1/327 (0.31%)  1 1/161 (0.62%)  1
Renal and urinary disorders     
Acute kidney injury  1  4/327 (1.22%)  5 0/161 (0.00%)  0
Chronic kidney disease  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Nephrolithiasis  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Urinary tract obstruction  1  1/327 (0.31%)  2 0/161 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  3/327 (0.92%)  5 1/161 (0.62%)  1
Pharyngeal inflammation  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Pleural effusion  1  0/327 (0.00%)  0 1/161 (0.62%)  2
Pneumonitis  1  3/327 (0.92%)  3 0/161 (0.00%)  0
Pulmonary fibrosis  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Respiratory failure  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Vascular disorders     
Embolism  1  8/327 (2.45%)  10 1/161 (0.62%)  1
Haematoma  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Pelvic venous thrombosis  1  1/327 (0.31%)  1 0/161 (0.00%)  0
Peripheral ischaemia  1  1/327 (0.31%)  2 0/161 (0.00%)  0
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abemaciclib + NSAI Placebo + NSAI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   320/327 (97.86%)      135/161 (83.85%)    
Blood and lymphatic system disorders     
Anaemia  1  93/327 (28.44%)  251 8/161 (4.97%)  15
Leukopenia  1  68/327 (20.80%)  237 4/161 (2.48%)  6
Lymphopenia  1  23/327 (7.03%)  51 4/161 (2.48%)  4
Neutropenia  1  135/327 (41.28%)  507 3/161 (1.86%)  18
Thrombocytopenia  1  34/327 (10.40%)  68 3/161 (1.86%)  10
Eye disorders     
Lacrimation increased  1  19/327 (5.81%)  26 1/161 (0.62%)  1
Gastrointestinal disorders     
Abdominal pain  1  95/327 (29.05%)  139 18/161 (11.18%)  21
Constipation  1  51/327 (15.60%)  69 20/161 (12.42%)  24
Diarrhoea  1  264/327 (80.73%)  922 48/161 (29.81%)  84
Dyspepsia  1  25/327 (7.65%)  31 3/161 (1.86%)  3
Nausea  1  126/327 (38.53%)  220 32/161 (19.88%)  41
Stomatitis  1  37/327 (11.31%)  47 17/161 (10.56%)  23
Vomiting  1  92/327 (28.13%)  131 18/161 (11.18%)  30
General disorders     
Fatigue  1  131/327 (40.06%)  240 51/161 (31.68%)  74
Influenza like illness  1  34/327 (10.40%)  46 13/161 (8.07%)  16
Oedema peripheral  1  30/327 (9.17%)  36 9/161 (5.59%)  9
Pain  1  26/327 (7.95%)  32 9/161 (5.59%)  10
Pyrexia  1  24/327 (7.34%)  29 12/161 (7.45%)  13
Infections and infestations     
Upper respiratory tract infection  1  31/327 (9.48%)  37 8/161 (4.97%)  11
Urinary tract infection  1  27/327 (8.26%)  35 15/161 (9.32%)  25
Investigations     
Alanine aminotransferase increased  1  51/327 (15.60%)  120 11/161 (6.83%)  14
Aspartate aminotransferase increased  1  48/327 (14.68%)  98 12/161 (7.45%)  13
Blood creatinine increased  1  61/327 (18.65%)  126 6/161 (3.73%)  7
Weight decreased  1  33/327 (10.09%)  60 5/161 (3.11%)  8
Metabolism and nutrition disorders     
Decreased appetite  1  80/327 (24.46%)  122 15/161 (9.32%)  20
Hypokalaemia  1  22/327 (6.73%)  38 1/161 (0.62%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  41/327 (12.54%)  64 27/161 (16.77%)  39
Back pain  1  39/327 (11.93%)  49 24/161 (14.91%)  30
Bone pain  1  25/327 (7.65%)  32 12/161 (7.45%)  14
Myalgia  1  28/327 (8.56%)  32 9/161 (5.59%)  11
Pain in extremity  1  25/327 (7.65%)  38 17/161 (10.56%)  21
Nervous system disorders     
Dizziness  1  37/327 (11.31%)  49 15/161 (9.32%)  17
Dysgeusia  1  30/327 (9.17%)  36 3/161 (1.86%)  3
Headache  1  51/327 (15.60%)  84 24/161 (14.91%)  35
Neuropathy  1  30/327 (9.17%)  35 13/161 (8.07%)  15
Psychiatric disorders     
Insomnia  1  22/327 (6.73%)  25 14/161 (8.70%)  15
Respiratory, thoracic and mediastinal disorders     
Cough  1  43/327 (13.15%)  60 15/161 (9.32%)  22
Dyspnoea  1  39/327 (11.93%)  52 8/161 (4.97%)  12
Skin and subcutaneous tissue disorders     
Alopecia  1  87/327 (26.61%)  91 17/161 (10.56%)  18
Dry skin  1  27/327 (8.26%)  36 4/161 (2.48%)  4
Pruritus  1  43/327 (13.15%)  61 14/161 (8.70%)  17
Rash  1  47/327 (14.37%)  64 8/161 (4.97%)  12
Vascular disorders     
Hot flush  1  32/327 (9.79%)  33 27/161 (16.77%)  31
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: clinicaltrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02246621     History of Changes
Other Study ID Numbers: 15417
I3Y-MC-JPBM ( Other Identifier: Eli Lilly and Company )
2014-001502-18 ( EudraCT Number )
First Submitted: September 18, 2014
First Posted: September 23, 2014
Results First Submitted: January 31, 2018
Results First Posted: March 23, 2018
Last Update Posted: September 10, 2019