A Study of Olaratumab in Japanese Participants With Advanced Cancer
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02377752
Collaborator
(none)
25
4
4
57.8
6.3
0.1
Study Details
Study Description
Brief Summary
This study consists of 2 parts (Part A and Part B). The main purpose of Part A is to evaluate safety and side effects of olaratumab in combination with doxorubicin in Japanese participants with a group of rare cancers (advanced solid tumors, especially advanced soft tissue sarcoma [STS].) The main purpose of Part B is to evaluate how much olaratumab gets into the blood stream of Japanese participants with advanced solid tumors and how long it takes the body to get rid of it.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
25 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study of Olaratumab in Japanese Patients With Advanced Soft Tissue Sarcoma or Advanced Solid Tumors
Actual Study Start Date
:
Mar 23, 2015
Actual Primary Completion Date
:
Aug 27, 2018
Actual Study Completion Date
:
Jan 14, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part A cohort 1: Olaratumab+Doxorubicin 15 milligram per kilogram (mg/kg) of olaratumab administered intravenously (IV) on Day 1 and Day 8, and 25 milligram per square meter (mg/m2) of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met . |
Biological: Olaratumab
Administered IV
Other Names:
Drug: Doxorubicin
Administered IV
|
| Experimental: Part A cohort 2: Olaratumab+Doxorubicin 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
Biological: Olaratumab
Administered IV
Other Names:
Drug: Doxorubicin
Administered IV
|
| Experimental: Part A cohort 3 Olaratumab + Doxorubicin 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
Biological: Olaratumab
Administered IV
Other Names:
Drug: Doxorubicin
Administered IV
|
| Experimental: Part B: Olaratumab 15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. |
Biological: Olaratumab
Administered IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Part A: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline to Study completion (Up To 3.5 Years)]
Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
- Part A: Number of Participants With Dose Limiting Toxicities (DLTs) [Cycle 1 (21 Days)]
DLT is defined as adverse event (AE) during Cycle 1 (Days 1 through 21) that was possibly related to the study drug and toxicities considered by the investigator as dose limiting. A summary of other nonserious AEs, and all serious adverse events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
- Part B: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Olaratumab [Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion]
Maximum observed serum concentration (Cmax) of olaratumab is reported.
- Part B: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Olaratumab [Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion]
AUC(0-t) hours (h), area under the serum concentration versus time curve from time zero to t hours at AUC(0-168h) for Cycle 1 Day 1 and Cycle 3 Day 1, AUC(0-336h) for Cycle 1 Day 8 and Cycle 3 Day 8 of Olaratumab is reported.
Secondary Outcome Measures
- Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Olaratumab [Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1.5, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion]
Maximum observed serum concentration (Cmax) of olaratumab is reported.
- Part A: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Olaratumab [Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1.5, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion]
AUC(0-t) hours (h), area under the serum concentration versus time curve from time zero to t hours at AUC(0-168h) for Cycle 1 Day 1 and Cycle 3 Day 1, AUC(0-336h) for Cycle 1 Day 8 and Cycle 3 Day 8 of Olaratumab is reported.
- Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Doxorubicin [Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3, Cycle 3 Day 1, Cycle 3 Day 2 and Cycle 3 Day 3: Immediately postinfusion]
Maximum observed plasma concentration (Cmax) of doxorubicin is reported.
- Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Doxorubicin [Cycle 1 Day 1 and Cycle 3 Day 1: Immediately postinfusion, 0.5, 1, 2, 4, 8, 24, 48, and 72 h postinfusion]
Maximum observed plasma concentration (Cmax) of doxorubicin is reported.
- Part A: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Doxorubicin [Cycle 1 Day 1 and Cycle 3 Day 1: Immediately postinfusion, 0.5, 1, 2, 4, 8, 24, 48, and 72 h postinfusion]
Area under the concentration verses time curve from zero to infinity (AUC[0-∞]) of doxorubicin is reported.
- Change From Baseline in Percentage of Participants With a Tumor Response [Baseline to Study completion (Up To 3.5 Years)]
Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is greater than or equal to (≥) 30% decrease in sum of longest diameter of target lesions.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Part A: Have histological or cytological evidence of a diagnosis of advanced or metastatic solid tumor, especially STS, which is not amenable to treatment with surgery or radiotherapy. Part B: Have histological or cytological evidence of a diagnosis of solid tumor that is advanced or metastatic.
-
Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
-
Have given written informed consent prior to any study-specific procedures.
-
Have adequate organ and coagulation function
-
Have an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of less than or equal to 1.
-
Have discontinued previous treatments for cancer and recovered from the acute effects of therapy.
-
(Part A only) Have a prestudy echocardiogram with an actual left ventricular ejection fraction greater than or equal to 50%, within 21 days prior to first dose of study medication.
-
All participants agree to use a reliable method of birth control and to not donate sperm during the study and for at least 3 months following last dose of study drug.
-
Female participants:
-
must either be women not of child-bearing potential due to surgical sterilization confirmed by medical history, or menopause or
-
women of child-bearing potential who test negative for pregnancy within 7 days before the first dose of study drug based on serum or urine pregnancy test and agree not to breast feed during the study and for 3 months following the last dose of the study drug(s)
-
Have an estimated life expectancy of more than or equal to 3 months in the judgment of the investigator.
Exclusion Criteria:
-
Have received treatment within 21 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device for non-cancer indications or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
-
(Part A only) Have received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones
-
(Part A only) Have received prior radiation therapy to the mediastinal/pericardial area.
-
Have symptomatic central nervous system malignancy or metastasis. Participants with treated central nervous system (CNS) metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 60 days.
-
Have an elective or a planned major surgery to be performed during the course of the study.
-
Have an uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure greater than class II of the New York Heart Association guideline, severe myocardial insufficiency, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
-
Have unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months prior to study entry.
-
Have a known allergy to any of the treatment components.
-
Have a history of allergic reactions attributed to compounds of chemical or biologic composition similar to that of olaratumab.
-
Have a known active fungal, bacterial, and/or known viral infection
-
Have a corrected QT interval of greater than 470 milliseconds (msec) on screening electrocardiogram (ECG)
-
Have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. | Chuo-Ku | Japan | 104-0045 | |
| 2 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. | Koto-ku | Japan | 135-8550 | |
| 3 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. | Nagoya | Japan | 466-8560 | |
| 4 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. | Suita-shi | Japan | 565-0871 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02377752
Other Study ID Numbers:
- 15678
- I5B-JE-JGDK
First Posted:
Mar 4, 2015
Last Update Posted:
Feb 17, 2021
Last Verified:
Feb 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Participants were considered to have competed the study if the study discontinued due to adverse event, progressive disease (PD) or withdrawal by subject. |
| Arm/Group Title | Part A Cohort 1: Olaratumab+Doxorubicin | Part A Cohort 2: Olaratumab+Doxorubicin | Part A Cohort 3 Olaratumab + Doxorubicin | Part B: Olaratumab |
|---|---|---|---|---|
| Arm/Group Description | 15 milligram per kilogram (mg/kg) of olaratumab administered intravenously (IV) on Day 1 and Day 8, and 25 milligram per square meter (mg/m2) of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. |
| Period Title: Overall Study | ||||
| STARTED | 7 | 6 | 6 | 6 |
| Received at Least 1 Dose of Study Drug | 7 | 6 | 6 | 6 |
| COMPLETED | 7 | 6 | 6 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Part A Cohort 1: Olaratumab+Doxorubicin | Part A Cohort 2: Olaratumab+Doxorubicin | Part A Cohort 3 Olaratumab + Doxorubicin | Part B: Olaratumab | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 25 mg/m2 of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. | Total of all reporting groups |
| Overall Participants | 7 | 6 | 6 | 6 | 25 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
50.1
(15.3)
|
45.8
(11.0)
|
40.7
(8.7)
|
59.3
(8.1)
|
49.0
(12.7)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
4
57.1%
|
2
33.3%
|
5
83.3%
|
5
83.3%
|
16
64%
|
| Male |
3
42.9%
|
4
66.7%
|
1
16.7%
|
1
16.7%
|
9
36%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
7
100%
|
6
100%
|
6
100%
|
6
100%
|
25
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||||
| Japan |
7
100%
|
6
100%
|
6
100%
|
6
100%
|
25
100%
|
Outcome Measures
| Title | Part A: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
|---|---|
| Description | Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
| Time Frame | Baseline to Study completion (Up To 3.5 Years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) in Part A. |
| Arm/Group Title | Part A Cohort 1: Olaratumab+Doxorubicin | Part A Cohort 2: Olaratumab+Doxorubicin | Part A Cohort 3 Olaratumab + Doxorubicin |
|---|---|---|---|
| Arm/Group Description | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 25 mg/m2 of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Measure Participants | 7 | 6 | 6 |
| Number [participants] |
1
14.3%
|
4
66.7%
|
1
16.7%
|
| Title | Part A: Number of Participants With Dose Limiting Toxicities (DLTs) |
|---|---|
| Description | DLT is defined as adverse event (AE) during Cycle 1 (Days 1 through 21) that was possibly related to the study drug and toxicities considered by the investigator as dose limiting. A summary of other nonserious AEs, and all serious adverse events (SAE's), regardless of causality, is located in the Reported Adverse Events section. |
| Time Frame | Cycle 1 (21 Days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled patients who completed Cycle 1 (initial 21-day treatment period), or who discontinued due to DLT during Cycle 1 in Part A. |
| Arm/Group Title | Part A Cohort 1: Olaratumab+Doxorubicin | Part A Cohort 2: Olaratumab+Doxorubicin | Part A Cohort 3 Olaratumab + Doxorubicin |
|---|---|---|---|
| Arm/Group Description | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 25 mg/m2 of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Measure Participants | 7 | 6 | 6 |
| Count of Participants [Participants] |
0
0%
|
1
16.7%
|
0
0%
|
| Title | Part B: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Olaratumab |
|---|---|
| Description | Maximum observed serum concentration (Cmax) of olaratumab is reported. |
| Time Frame | Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received any amount of study drug (olaratumab) and had evaluable pharmacokinetics (PK) data in Part B. |
| Arm/Group Title | Part B: Olaratumab |
|---|---|
| Arm/Group Description | 15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. |
| Measure Participants | 6 |
| Cycle 1 Day 1 |
322
(22)
|
| Cycle 1 Day 8 |
409
(32)
|
| Cycle 3 Day 1 |
396
(16)
|
| Cycle 3 Day 8 |
478
(15)
|
| Title | Part B: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Olaratumab |
|---|---|
| Description | AUC(0-t) hours (h), area under the serum concentration versus time curve from time zero to t hours at AUC(0-168h) for Cycle 1 Day 1 and Cycle 3 Day 1, AUC(0-336h) for Cycle 1 Day 8 and Cycle 3 Day 8 of Olaratumab is reported. |
| Time Frame | Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received any amount of study drug (olaratumab) and had evaluable PK data in Part B. |
| Arm/Group Title | Part B: Olaratumab |
|---|---|
| Arm/Group Description | 15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. |
| Measure Participants | 6 |
| Cycle 1 Day 1: AUC(0-168h) |
23300
(26)
|
| Cycle 1 Day 8: AUC(0-336h) |
48100
(47)
|
| Cycle 3 Day 1: AUC(0-168h) |
39800
(14)
|
| Cycle 3 Day 8: AUC(0-336h) |
NA
(NA)
|
| Title | Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Olaratumab |
|---|---|
| Description | Maximum observed serum concentration (Cmax) of olaratumab is reported. |
| Time Frame | Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1.5, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) and had evaluable PK data in Part A. |
| Arm/Group Title | Part A Cohort 1: Olaratumab+Doxorubicin | Part A Cohort 2: Olaratumab+Doxorubicin | Part A Cohort 3 Olaratumab + Doxorubicin |
|---|---|---|---|
| Arm/Group Description | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 25 mg/m2 of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Measure Participants | 6 | 6 | 6 |
| Cycle 1 Day 1 |
274
(30)
|
301
(25)
|
470
(27)
|
| Cycle 1 Day 8 |
353
(40)
|
351
(20)
|
610
(33)
|
| Cycle 3 Day 1 |
351
(28)
|
390
(13)
|
545
(34)
|
| Cycle 3 Day 8 |
415
(28)
|
474
(13)
|
541
(41)
|
| Title | Part A: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Olaratumab |
|---|---|
| Description | AUC(0-t) hours (h), area under the serum concentration versus time curve from time zero to t hours at AUC(0-168h) for Cycle 1 Day 1 and Cycle 3 Day 1, AUC(0-336h) for Cycle 1 Day 8 and Cycle 3 Day 8 of Olaratumab is reported. |
| Time Frame | Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1.5, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) and had evaluable PK data in Part A. |
| Arm/Group Title | Part A Cohort 1: Olaratumab+Doxorubicin | Part A Cohort 2: Olaratumab+Doxorubicin | Part A Cohort 3 Olaratumab + Doxorubicin |
|---|---|---|---|
| Arm/Group Description | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 25 mg/m2 of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Measure Participants | 6 | 6 | 6 |
| Cycle 1 Day 1: AUC(0-168h) |
21700
(36)
|
21900
(25)
|
34300
(29)
|
| Cycle 1 Day 8: AUC(0-336h) |
47300
(32)
|
42000
(36)
|
74100
(42)
|
| Cycle 3 Day 1: AUC(0-168h) |
33600
(31)
|
36000
(15)
|
42500
(51)
|
| Cycle 3 Day 8: AUC(0-336h) |
63000
(28)
|
68400
(15)
|
77700
(68)
|
| Title | Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Doxorubicin |
|---|---|
| Description | Maximum observed plasma concentration (Cmax) of doxorubicin is reported. |
| Time Frame | Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3, Cycle 3 Day 1, Cycle 3 Day 2 and Cycle 3 Day 3: Immediately postinfusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) and had evaluable PK data in Part A. |
| Arm/Group Title | Part A Cohort 1: Olaratumab+Doxorubicin |
|---|---|
| Arm/Group Description | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 25 mg/m2 of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Measure Participants | 6 |
| Cycle 1 Day 1 |
594
(86)
|
| Cycle 1 Day 2 |
444
(97)
|
| Cycle 1 Day 3 |
384
(105)
|
| Cycle 3 Day 1 |
855
(29)
|
| Cycle 3 Day 2 |
742
(45)
|
| Cycle 3 Day 3 |
884
(24)
|
| Title | Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Doxorubicin |
|---|---|
| Description | Maximum observed plasma concentration (Cmax) of doxorubicin is reported. |
| Time Frame | Cycle 1 Day 1 and Cycle 3 Day 1: Immediately postinfusion, 0.5, 1, 2, 4, 8, 24, 48, and 72 h postinfusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) and had evaluable PK data in Part A. |
| Arm/Group Title | Part A Cohort 2: Olaratumab+Doxorubicin | Part A Cohort 3 Olaratumab + Doxorubicin |
|---|---|---|
| Arm/Group Description | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Measure Participants | 6 | 6 |
| Cycle 1 Day 1 |
2660
(25)
|
2790
(12)
|
| Cycle 3 Day 1 |
NA
(NA)
|
2900
(19)
|
| Title | Part A: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Doxorubicin |
|---|---|
| Description | Area under the concentration verses time curve from zero to infinity (AUC[0-∞]) of doxorubicin is reported. |
| Time Frame | Cycle 1 Day 1 and Cycle 3 Day 1: Immediately postinfusion, 0.5, 1, 2, 4, 8, 24, 48, and 72 h postinfusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) and had evaluable PK data in Part A. AUC data is not available for Part A cohort 1 as PK was evaluated immediately post infusion of doxorubicin in Part A cohort 1. |
| Arm/Group Title | Part A Cohort 2: Olaratumab+Doxorubicin | Part A Cohort 3 Olaratumab + Doxorubicin |
|---|---|---|
| Arm/Group Description | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Measure Participants | 6 | 6 |
| Cycle 1 Day 1 |
3070
(12)
|
3020
(15)
|
| Cycle 3 Day 1 |
NA
(NA)
|
3720
(17)
|
| Title | Change From Baseline in Percentage of Participants With a Tumor Response |
|---|---|
| Description | Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is greater than or equal to (≥) 30% decrease in sum of longest diameter of target lesions. |
| Time Frame | Baseline to Study completion (Up To 3.5 Years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) in Part A and Part B. |
| Arm/Group Title | Part A Cohort 1: Olaratumab+Doxorubicin | Part A Cohort 2: Olaratumab+Doxorubicin | Part A Cohort 3 Olaratumab + Doxorubicin | Part B: Olaratumab |
|---|---|---|---|---|
| Arm/Group Description | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 25 mg/m2 of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. |
| Measure Participants | 7 | 6 | 6 | 6 |
| Number (95% Confidence Interval) [percentage of participants] |
0
0%
|
33.3
555%
|
33.3
555%
|
0
0%
|
Adverse Events
| Time Frame | Baseline to Study completion (Up To 3.5 Years) | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) in Part A and Part B. | |||||||
| Arm/Group Title | Part A Cohort 1: Olaratumab+Doxorubicin | Part A Cohort 2: Olaratumab+Doxorubicin | Part A Cohort 3 Olaratumab + Doxorubicin | Part B: Olaratumab | ||||
| Arm/Group Description | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 25 mg/m2 of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. | ||||
All Cause Mortality |
||||||||
| Part A Cohort 1: Olaratumab+Doxorubicin | Part A Cohort 2: Olaratumab+Doxorubicin | Part A Cohort 3 Olaratumab + Doxorubicin | Part B: Olaratumab | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||
Serious Adverse Events |
||||||||
| Part A Cohort 1: Olaratumab+Doxorubicin | Part A Cohort 2: Olaratumab+Doxorubicin | Part A Cohort 3 Olaratumab + Doxorubicin | Part B: Olaratumab | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/7 (14.3%) | 4/6 (66.7%) | 1/6 (16.7%) | 2/6 (33.3%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Febrile neutropenia | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Cardiac disorders | ||||||||
| Left ventricular dysfunction | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Ileus | 0/7 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Hepatobiliary disorders | ||||||||
| Hepatic function abnormal | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Infections and infestations | ||||||||
| Lung infection | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Meningitis | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Pneumonia | 0/7 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Injury, poisoning and procedural complications | ||||||||
| Infusion related reaction | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Investigations | ||||||||
| Neutrophil count decreased | 0/7 (0%) | 0 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Platelet count decreased | 0/7 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
| Part A Cohort 1: Olaratumab+Doxorubicin | Part A Cohort 2: Olaratumab+Doxorubicin | Part A Cohort 3 Olaratumab + Doxorubicin | Part B: Olaratumab | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/7 (100%) | 6/6 (100%) | 6/6 (100%) | 5/6 (83.3%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 3/7 (42.9%) | 3 | 3/6 (50%) | 5 | 1/6 (16.7%) | 1 | 2/6 (33.3%) | 2 |
| Neutropenia | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Cardiac disorders | ||||||||
| Cardiac failure | 0/7 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Palpitations | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Sinus tachycardia | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Eye disorders | ||||||||
| Eye pain | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Abdominal pain upper | 0/7 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Constipation | 4/7 (57.1%) | 6 | 3/6 (50%) | 4 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 |
| Diarrhoea | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 2/6 (33.3%) | 3 | 0/6 (0%) | 0 |
| Gastritis | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Mouth haemorrhage | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Nausea | 5/7 (71.4%) | 9 | 6/6 (100%) | 11 | 6/6 (100%) | 8 | 1/6 (16.7%) | 1 |
| Stomatitis | 2/7 (28.6%) | 3 | 4/6 (66.7%) | 5 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Vomiting | 1/7 (14.3%) | 1 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 2 | 0/6 (0%) | 0 |
| General disorders | ||||||||
| Catheter site pain | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Chills | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Fatigue | 3/7 (42.9%) | 4 | 5/6 (83.3%) | 5 | 3/6 (50%) | 3 | 0/6 (0%) | 0 |
| Malaise | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 2/6 (33.3%) | 5 |
| Oedema | 0/7 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Oedema peripheral | 0/7 (0%) | 0 | 1/6 (16.7%) | 2 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Pyrexia | 4/7 (57.1%) | 5 | 4/6 (66.7%) | 6 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Immune system disorders | ||||||||
| Hypersensitivity | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Infections and infestations | ||||||||
| Cystitis | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Gingivitis | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Hand-foot-and-mouth disease | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Nasopharyngitis | 2/7 (28.6%) | 2 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Pharyngitis | 0/7 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Upper respiratory tract infection | 1/7 (14.3%) | 1 | 3/6 (50%) | 5 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 |
| Investigations | ||||||||
| Activated partial thromboplastin time prolonged | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Alanine aminotransferase increased | 3/7 (42.9%) | 4 | 3/6 (50%) | 4 | 4/6 (66.7%) | 6 | 0/6 (0%) | 0 |
| Aspartate aminotransferase increased | 2/7 (28.6%) | 6 | 3/6 (50%) | 3 | 3/6 (50%) | 8 | 0/6 (0%) | 0 |
| Blood alkaline phosphatase increased | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Blood creatinine increased | 0/7 (0%) | 0 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Blood phosphorus decreased | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Electrocardiogram qt prolonged | 1/7 (14.3%) | 1 | 2/6 (33.3%) | 2 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 |
| Gamma-glutamyltransferase increased | 0/7 (0%) | 0 | 3/6 (50%) | 3 | 3/6 (50%) | 3 | 0/6 (0%) | 0 |
| Haemoglobin decreased | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Lymphocyte count decreased | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Neutrophil count decreased | 2/7 (28.6%) | 8 | 5/6 (83.3%) | 14 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Platelet count decreased | 2/7 (28.6%) | 4 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Weight decreased | 1/7 (14.3%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| White blood cell count decreased | 2/7 (28.6%) | 9 | 6/6 (100%) | 13 | 1/6 (16.7%) | 2 | 0/6 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 4/7 (57.1%) | 6 | 2/6 (33.3%) | 3 | 4/6 (66.7%) | 5 | 0/6 (0%) | 0 |
| Hypoalbuminaemia | 0/7 (0%) | 0 | 2/6 (33.3%) | 3 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Hypocalcaemia | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Hypokalaemia | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Back pain | 1/7 (14.3%) | 1 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Myalgia | 0/7 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Myositis | 0/7 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Pain in extremity | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Tumour pain | 0/7 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 |
| Nervous system disorders | ||||||||
| Dysgeusia | 1/7 (14.3%) | 1 | 5/6 (83.3%) | 5 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Headache | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 2 | 0/6 (0%) | 0 |
| Psychiatric disorders | ||||||||
| Insomnia | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 |
| Renal and urinary disorders | ||||||||
| Pollakiuria | 0/7 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 1/7 (14.3%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Hiccups | 1/7 (14.3%) | 5 | 3/6 (50%) | 5 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Oropharyngeal pain | 1/7 (14.3%) | 2 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Alopecia | 4/7 (57.1%) | 4 | 6/6 (100%) | 6 | 6/6 (100%) | 6 | 0/6 (0%) | 0 |
| Dermatitis acneiform | 0/7 (0%) | 0 | 3/6 (50%) | 3 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Dry skin | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Nail discolouration | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Pruritus | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Pustular psoriasis | 0/7 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Rash | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Rash maculo-papular | 1/7 (14.3%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Urticaria | 1/7 (14.3%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Vascular disorders | ||||||||
| Phlebitis | 0/7 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Vascular pain | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Vasculitis | 1/7 (14.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Principal investigators are fully restricted to publish any results of the study without sponsor's permission.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
| ClinicalTrials.gov@lilly.com |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02377752
Other Study ID Numbers:
- 15678
- I5B-JE-JGDK
First Posted:
Mar 4, 2015
Last Update Posted:
Feb 17, 2021
Last Verified:
Feb 1, 2020