We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Olaratumab and Doxorubicin in Participants With Advanced Soft Tissue Sarcoma

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: NCT02326025
Recruitment Status : Completed
First Posted : December 25, 2014
Results First Posted : November 21, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Sarcoma, Soft Tissue
Interventions Drug: Olaratumab
Drug: Doxorubicin
Enrollment 49
Recruitment Details  
Pre-assignment Details Completers include participants who died or discontinued study treatment due to progressive disease.
Arm/Group Title Part A Part B
Hide Arm/Group Description

Doxorubicin (Dox) Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV).

Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.

Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met.

Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV

Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV.

Olaratumab + Doxorubicin:

For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.

For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met.

Period Title: Overall Study
Started 25 24
Received at Least 1 Dose of Study Drug 25 24
Completed 20 19
Not Completed 5 5
Reason Not Completed
Adverse Event             3             0
Physician Decision             1             2
Physician and Participant Decision             1             0
Withdrawal by Subject             0             2
Protocol Violation             0             1
Arm/Group Title Part A Part B Total
Hide Arm/Group Description

Doxorubicin Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV).

Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.

Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met.

Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV

Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV.

Olaratumab + Doxorubicin:

For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.

For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met.

Total of all reporting groups
Overall Number of Baseline Participants 25 24 49
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 24 participants 49 participants
56.7  (12.6) 56.1  (11.2) 56.4  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 participants
Female 15 14 29
Male 10 10 20
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 participants
Hispanic or Latino 1 2 3
Not Hispanic or Latino 24 22 46
Unknown or Not Reported 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 participants
American Indian or Alaska Native 0 1 1
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 3 1 4
White 22 22 44
More than one race 0 0 0
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants 24 participants 49 participants
25 24 49
1.Primary Outcome
Title Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) Doxorubicin
Hide Description [Not Specified]
Time Frame Cycle(C)1 and (C)2, Day(D)1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hours (Hrs) Post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drugs and had evaluable PK data.
Arm/Group Title Part A Doxorubicin Alone Part A Doxorubicin + 15 mg/kg Olaratumab Part B Doxorubicin Alone Part B Doxorubicin + 20 mg/kg Olaratumab
Hide Arm/Group Description:
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV.
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 1, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV
On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
Overall Number of Participants Analyzed 23 22 24 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour/milliliter (ng*h/mL)
2580
(24%)
2570
(28%)
2400
(21%)
2470
(20%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A Doxorubicin Alone, Part A Doxorubicin + 15 mg/kg Olaratumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.04
Confidence Interval (2-Sided) 90%
0.964 to 1.13
Estimation Comments Log(PK) is participant and treatment and random error, where participant is fitted as a random effect.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B Doxorubicin Alone, Part B Doxorubicin + 20 mg/kg Olaratumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS Means
Estimated Value 1.03
Confidence Interval (2-Sided) 90%
0.957 to 1.11
Estimation Comments [Not Specified]
2.Primary Outcome
Title PK: Maximum Concentration (Cmax) Doxorubicin
Hide Description [Not Specified]
Time Frame C1 and C2, D1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hrs Post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drugs and had evaluable PK data.
Arm/Group Title Part A Doxorubicin Alone Part A Doxorubicin + 15 mg/kg Olaratumab Part B Doxorubicin Alone Part B Doxorubicin + 20 mg/kg Olaratumab
Hide Arm/Group Description:
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin, IV.
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 1, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV
On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
Overall Number of Participants Analyzed 23 22 24 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram/milliliter (ng/ml)
2570
(47%)
2330
(68%)
2060
(53%)
2070
(60%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A Doxorubicin Alone, Part A Doxorubicin + 15 mg/kg Olaratumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS Means
Estimated Value 0.944
Confidence Interval (2-Sided) 90%
0.770 to 1.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B Doxorubicin Alone, Part B Doxorubicin + 20 mg/kg Olaratumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of LS Means
Estimated Value 1.03
Confidence Interval (2-Sided) 90%
0.801 to 1.33
Estimation Comments [Not Specified]
3.Secondary Outcome
Title PK:Time of Maximum Observed Concentration (Tmax) Doxorubicin
Hide Description [Not Specified]
Time Frame C1 and C2, D1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hrs Post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drugs and had evaluable PK data.
Arm/Group Title Part A Doxorubicin Alone Part A Doxorubicin + 15 mg/kg Olaratumab Part B Doxorubicin Alone Part B Doxorubicin + 20 mg/kg Olaratumab
Hide Arm/Group Description:
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin, IV.
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 1, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV
On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
Overall Number of Participants Analyzed 23 22 24 21
Median (Full Range)
Unit of Measure: hour (h)
0.30
(0.25 to 0.58)
0.31
(0.25 to 0.58)
0.33
(0.25 to 0.67)
0.33
(0.25 to 0.55)
4.Secondary Outcome
Title PK: AUC Zero to Time t, Where t is the Last Time Point (0-tLast) Olaratumab
Hide Description PK: AUC (0-tLast) with a measurable concentration. PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin.
Time Frame C1 D10: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose; C2 D1: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drugs and had evaluable PK data.
Arm/Group Title Olaratumab Alone Part A Part A 15 mg/kg Olaratumab + Doxorubicin Part B Olaratumab Alone Part B 20 mg/kg Olaratumab + Doxorubicin
Hide Arm/Group Description:
On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV.
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab, IV
On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
Overall Number of Participants Analyzed 23 24 23 23
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng∙h/mL
32800
(21%)
32000
(21%)
53800
(24%)
54100
(20%)
5.Secondary Outcome
Title PK: Cmax Olaratumab
Hide Description PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin.
Time Frame C1 D10:Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose; C2 D1: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drugs and had evaluable PK data.
Arm/Group Title Part A Olaratumab Alone Part A 15 mg/kg Olaratumab + Doxorubicin Part B Olaratumab Alone Part B 20 mg/kg Olaratumab + Doxorubicin
Hide Arm/Group Description:
On Cycle 1, Day 10, participants received 15 mg/kg of olaratumab, IV.
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab, IV.
On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
Overall Number of Participants Analyzed 23 24 23 23
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
292
(19%)
386
(16%)
512
(21%)
634
(26%)
6.Secondary Outcome
Title PK: Tmax Olaratumab
Hide Description Tmax times are relative to the start of the approximately 60-minute IV infusion of olaratumab. PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin.
Time Frame C1 D10: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose; C2 D1: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drugs and had evaluable PK data.
Arm/Group Title Part A Olaratumab Alone Part A 15 mg/kg Olaratumab + Doxorubicin Part B Olaratumab Alone Part B 20 mg/kg Olaratumab + Doxorubicin
Hide Arm/Group Description:
On Cycle 1, Day 10, participants received 15 mg/kg of olaratumab, IV.
On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.
On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab, IV
On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.
Overall Number of Participants Analyzed 23 24 23 23
Median (Full Range)
Unit of Measure: h
2.00
(1.00 to 23.17)
2.79
(1.80 to 6.43)
1.67
(0.05 to 24.10)
3.50
(1.00 to 6.97)
7.Secondary Outcome
Title Percentage of Participants With Olaratumab Antibodies
Hide Description The formation of anti-drug antibodies (ADA) was assessed using validated ELISAs, following a 4-tier approach. Both the ADA screening assay and the neutralizing antibody assay were validated in accordance with the US Food and Drug Administration (FDA) Guidance for Industry. Participants who had positive samples for treatment emergence due to being <4-fold difference from baseline or occurred prior to drug exposure are reported.
Time Frame Preinfusion on Day 1 of Cycles 1 through 3 and Preinfusion on Day 1 of Every Second Cycle Thereafter, Up to 30-Day Follow Up
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable baseline and post-baseline anti-olaratumab antibodies.
Arm/Group Title Part A 15 mg/kg Olaratumab Part B 20 mg/kg Olaratumab
Hide Arm/Group Description:

Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met.

Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met.

Overall Number of Participants Analyzed 25 24
Measure Type: Number
Unit of Measure: percentage of participants
0 0
8.Secondary Outcome
Title Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Hide Description The percentage of participants with a best overall response achieving CR or PR (ORR) was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions. The methodology for the confidence interval calculation is the "exact F" method.
Time Frame Baseline to Measured Progressive Disease, Study Discontinuation or Death (Up to 24 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had a post-baseline lesion response.
Arm/Group Title Part A Dox Alone, Then Olaratumab Alone, Then Dox + Olaratumab Part B Dox Alone, Then Olaratumab Alone, Then Dox + Olaratumab
Hide Arm/Group Description:

Doxorubicin Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV).

Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.

Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met.

Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV

Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV.

Olaratumab + Doxorubicin:

For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.

For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met.

Overall Number of Participants Analyzed 25 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.0
(2.5 to 31.2)
25.0
(9.8 to 46.7)
Time Frame From Baseline, to Study Completion (Up to 47 Months)
Adverse Event Reporting Description All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.
 
Arm/Group Title Part A Part B
Hide Arm/Group Description

Doxorubicin Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV).

Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.

Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met.

Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV

Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV.

Olaratumab + Doxorubicin:

For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.

For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met.

All-Cause Mortality
Part A Part B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Part A Part B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/25 (36.00%)      9/24 (37.50%)    
Blood and lymphatic system disorders     
Anaemia  1  1/25 (4.00%)  1 1/24 (4.17%)  2
Febrile neutropenia  1  1/25 (4.00%)  1 3/24 (12.50%)  4
Leukopenia  1  1/25 (4.00%)  1 0/24 (0.00%)  0
Neutropenia  1  2/25 (8.00%)  2 1/24 (4.17%)  1
Pancytopenia  1  0/25 (0.00%)  0 1/24 (4.17%)  1
Thrombocytopenia  1  2/25 (8.00%)  2 1/24 (4.17%)  1
Gastrointestinal disorders     
Colitis  1  0/25 (0.00%)  0 1/24 (4.17%)  1
Large intestine perforation  1  0/25 (0.00%)  0 1/24 (4.17%)  1
Nausea  1  1/25 (4.00%)  1 0/24 (0.00%)  0
Stomatitis  1  0/25 (0.00%)  0 1/24 (4.17%)  1
Vomiting  1  1/25 (4.00%)  1 0/24 (0.00%)  0
General disorders     
Asthenia  1  1/25 (4.00%)  1 0/24 (0.00%)  0
Pyrexia  1  2/25 (8.00%)  2 0/24 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  1/25 (4.00%)  1 0/24 (0.00%)  0
Infections and infestations     
Abscess  1  0/25 (0.00%)  0 1/24 (4.17%)  1
Gastroenteritis salmonella  1  1/25 (4.00%)  1 0/24 (0.00%)  0
Pneumonia  1  0/25 (0.00%)  0 1/24 (4.17%)  1
Sepsis  1  0/25 (0.00%)  0 1/24 (4.17%)  1
Metabolism and nutrition disorders     
Hyperglycaemia  1  1/25 (4.00%)  1 0/24 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Fistula  1  0/25 (0.00%)  0 1/24 (4.17%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour haemorrhage  1  1/25 (4.00%)  1 2/24 (8.33%)  3
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/25 (4.00%)  1 0/24 (0.00%)  0
Pleural effusion  1  1/25 (4.00%)  1 0/24 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  1/25 (4.00%)  1 1/24 (4.17%)  1
Embolism venous  1  0/25 (0.00%)  0 1/24 (4.17%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A Part B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/25 (96.00%)      24/24 (100.00%)    
Blood and lymphatic system disorders     
Anaemia  1  10/25 (40.00%)  11 8/24 (33.33%)  10
Neutropenia  1  9/25 (36.00%)  12 7/24 (29.17%)  10
Thrombocytopenia  1  7/25 (28.00%)  11 1/24 (4.17%)  1
Cardiac disorders     
Palpitations  1  1/25 (4.00%)  1 2/24 (8.33%)  3
Sinus tachycardia  1  0/25 (0.00%)  0 2/24 (8.33%)  2
Eye disorders     
Dry eye  1  2/25 (8.00%)  4 1/24 (4.17%)  1
Eye pain  1  2/25 (8.00%)  2 1/24 (4.17%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/25 (4.00%)  1 6/24 (25.00%)  7
Abdominal pain upper  1  2/25 (8.00%)  2 0/24 (0.00%)  0
Constipation  1  9/25 (36.00%)  9 12/24 (50.00%)  20
Diarrhoea  1  6/25 (24.00%)  7 12/24 (50.00%)  22
Dry mouth  1  1/25 (4.00%)  1 7/24 (29.17%)  7
Gastritis  1  0/25 (0.00%)  0 2/24 (8.33%)  2
Gastrooesophageal reflux disease  1  5/25 (20.00%)  7 3/24 (12.50%)  6
Nausea  1  13/25 (52.00%)  14 19/24 (79.17%)  31
Stomatitis  1  5/25 (20.00%)  6 4/24 (16.67%)  4
Vomiting  1  5/25 (20.00%)  6 8/24 (33.33%)  14
General disorders     
Asthenia  1  2/25 (8.00%)  2 1/24 (4.17%)  1
Chills  1  3/25 (12.00%)  3 1/24 (4.17%)  1
Fatigue  1  14/25 (56.00%)  19 18/24 (75.00%)  24
Mucosal inflammation  1  3/25 (12.00%)  4 8/24 (33.33%)  10
Non-cardiac chest pain  1  1/25 (4.00%)  1 3/24 (12.50%)  3
Oedema  1  2/25 (8.00%)  2 1/24 (4.17%)  1
Oedema peripheral  1  2/25 (8.00%)  2 5/24 (20.83%)  5
Pyrexia  1  2/25 (8.00%)  2 4/24 (16.67%)  6
Temperature intolerance  1  0/25 (0.00%)  0 2/24 (8.33%)  2
Infections and infestations     
Candida infection  1  0/25 (0.00%)  0 2/24 (8.33%)  2
Herpes zoster  1  0/25 (0.00%)  0 2/24 (8.33%)  2
Oral candidiasis  1  3/25 (12.00%)  3 1/24 (4.17%)  1
Upper respiratory tract infection  1  2/25 (8.00%)  2 5/24 (20.83%)  8
Urinary tract infection  1  2/25 (8.00%)  2 2/24 (8.33%)  3
Investigations     
Activated partial thromboplastin time prolonged  1  2/25 (8.00%)  2 1/24 (4.17%)  1
Blood creatinine increased  1  0/25 (0.00%)  0 3/24 (12.50%)  4
Ejection fraction decreased  1  2/25 (8.00%)  2 0/24 (0.00%)  0
Gamma-glutamyltransferase increased  1  0/25 (0.00%)  0 3/24 (12.50%)  3
International normalised ratio increased  1  1/25 (4.00%)  1 2/24 (8.33%)  2
Lymphocyte count decreased  1  4/25 (16.00%)  4 1/24 (4.17%)  3
Neutrophil count decreased  1  1/25 (4.00%)  1 2/24 (8.33%)  7
Platelet count decreased  1  3/25 (12.00%)  4 2/24 (8.33%)  10
Weight decreased  1  2/25 (8.00%)  2 2/24 (8.33%)  2
White blood cell count decreased  1  6/25 (24.00%)  8 4/24 (16.67%)  9
Metabolism and nutrition disorders     
Decreased appetite  1  7/25 (28.00%)  7 8/24 (33.33%)  9
Dehydration  1  3/25 (12.00%)  3 1/24 (4.17%)  1
Hypoalbuminaemia  1  2/25 (8.00%)  2 0/24 (0.00%)  0
Hypokalaemia  1  1/25 (4.00%)  1 2/24 (8.33%)  2
Hyponatraemia  1  2/25 (8.00%)  2 1/24 (4.17%)  1
Hypophosphataemia  1  0/25 (0.00%)  0 2/24 (8.33%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/25 (4.00%)  1 5/24 (20.83%)  6
Back pain  1  2/25 (8.00%)  2 4/24 (16.67%)  9
Bone pain  1  1/25 (4.00%)  1 4/24 (16.67%)  5
Muscle spasms  1  1/25 (4.00%)  1 3/24 (12.50%)  3
Myalgia  1  6/25 (24.00%)  6 0/24 (0.00%)  0
Neck pain  1  1/25 (4.00%)  1 2/24 (8.33%)  3
Pain in extremity  1  2/25 (8.00%)  3 3/24 (12.50%)  3
Nervous system disorders     
Dizziness  1  4/25 (16.00%)  5 7/24 (29.17%)  10
Dysgeusia  1  4/25 (16.00%)  6 8/24 (33.33%)  9
Headache  1  6/25 (24.00%)  6 4/24 (16.67%)  4
Neuropathy peripheral  1  0/25 (0.00%)  0 2/24 (8.33%)  2
Psychiatric disorders     
Anxiety  1  1/25 (4.00%)  2 3/24 (12.50%)  4
Depression  1  2/25 (8.00%)  2 2/24 (8.33%)  2
Insomnia  1  2/25 (8.00%)  2 3/24 (12.50%)  3
Renal and urinary disorders     
Dysuria  1  0/25 (0.00%)  0 2/24 (8.33%)  2
Pollakiuria  1  1/25 (4.00%)  1 2/24 (8.33%)  2
Proteinuria  1  2/25 (8.00%)  2 0/24 (0.00%)  0
Urinary incontinence  1  0/25 (0.00%)  0 2/24 (8.33%)  2
Respiratory, thoracic and mediastinal disorders     
Cough  1  9/25 (36.00%)  9 8/24 (33.33%)  8
Dysphonia  1  1/25 (4.00%)  1 3/24 (12.50%)  4
Dyspnoea  1  4/25 (16.00%)  5 5/24 (20.83%)  7
Hiccups  1  1/25 (4.00%)  1 2/24 (8.33%)  2
Hypoxia  1  1/25 (4.00%)  1 2/24 (8.33%)  2
Oropharyngeal pain  1  4/25 (16.00%)  5 1/24 (4.17%)  1
Rhinorrhoea  1  1/25 (4.00%)  1 2/24 (8.33%)  2
Skin and subcutaneous tissue disorders     
Alopecia  1  7/25 (28.00%)  7 10/24 (41.67%)  10
Hyperhidrosis  1  0/25 (0.00%)  0 2/24 (8.33%)  2
Nail discolouration  1  3/25 (12.00%)  3 0/24 (0.00%)  0
Pain of skin  1  2/25 (8.00%)  2 0/24 (0.00%)  0
Photosensitivity reaction  1  0/25 (0.00%)  0 2/24 (8.33%)  2
Pruritus  1  0/25 (0.00%)  0 3/24 (12.50%)  3
Rash  1  3/25 (12.00%)  4 3/24 (12.50%)  3
Vascular disorders     
Embolism  1  2/25 (8.00%)  2 1/24 (4.17%)  1
Hypertension  1  2/25 (8.00%)  2 3/24 (12.50%)  3
Hypotension  1  0/25 (0.00%)  0 2/24 (8.33%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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: NCT02326025    
Other Study ID Numbers: 15676
I5B-EW-JGDI ( Other Identifier: Eli Lilly and Company )
First Submitted: December 22, 2014
First Posted: December 25, 2014
Results First Submitted: October 31, 2019
Results First Posted: November 21, 2019
Last Update Posted: November 21, 2019