A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02529553
Collaborator
(none)
25
4
1
30.9
6.3
0.2
Study Details
Study Description
Brief Summary
The main purpose of this study is to evaluate the safety of the study drug known as LY3076226 in participants with advanced or metastatic cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study of LY3076226, a Fibroblast Growth Factor Receptor 3 (FGFR3) Antibody-Drug Conjugate, in Patients With Advanced or Metastatic Cancer
Study Start Date
:
Sep 1, 2015
Actual Primary Completion Date
:
Mar 28, 2018
Actual Study Completion Date
:
Mar 28, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY3076226 Part A (dose escalation in advanced cancer): LY3076226 administered intravenously (IV) on day 1 of each 21 day cycle. Part B (dose expansion in advanced urothelial carcinoma): LY3076226 administered IV on day 1 of each 21 day cycle. |
Drug: LY3076226
Administered IV
|
Outcome Measures
Primary Outcome Measures
- Maximum Tolerated Dose (MTD) of LY3076226 [Cycle 1 (21 Days)]
The MTD was defined as the highest dose tested that had less than 33% probability of causing a dose limiting toxicity (DLT).
Secondary Outcome Measures
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3076226 [Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours]
- PK: Area Under the Concentration-Time Curve (AUC) of LY3076226 [Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours]
- Number of Participants With Tumor Response [Baseline through Study Completion (Cycle 3, day 21)]
Tumor response was assessed using confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). Complete response (CR) was the disappearance of all target and non-target lesions and normalization of tumor marker levels of non-target lesions; partial response (PR) was at least a 30% decrease in the sum of the longest diameter of target lesions.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy.
-
Part B: Have a diagnosis of bladder cancer.
-
Part B: Have alterations of FGFR3.
-
Have adequate organ function.
-
Have discontinued previous treatments for cancer and have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior chemotherapy, surgery, or radiotherapy to Grade ≤1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (v 4.0).
-
If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug. If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breastfeeding.
Exclusion Criteria:
-
Have received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device (other than the study drug/device used in this study) or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
-
Have preexisting corneal disease that may interfere with assessment for potential eye toxicity during the study.
-
Have preexisting Grade ≥2 skin disorder (for example, erythema, dermatitis).
-
Have serious preexisting medical conditions (left to the discretion of the investigator).
-
Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Participants with treated 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 28 days.
-
Have current acute or chronic leukemia.
-
Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
-
Have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results. Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is allowed.
-
Have Fridericia-corrected QT interval (QTcF) >480 milliseconds on screening electrocardiogram (ECG).
-
Have a serious cardiac condition, such as congestive heart failure; New York Heart Association Class III/IV heart disease; unstable angina pectoris; myocardial infarction within the last 3 months; valvulopathy that is severe, moderate, or deemed clinically significant; or arrhythmias that are symptomatic or require treatment (not including participants with rate-controlled atrial fibrillation).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111-2497 |
| 2 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 3 | The START Center for Cancer Care | San Antonio | Texas | United States | 78229 |
| 4 | For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Vancouver | British Columbia | Canada | V5Z 4E6 |
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02529553
Other Study ID Numbers:
- 15383
- I7O-MC-JOBA
First Posted:
Aug 20, 2015
Last Update Posted:
Apr 17, 2020
Last Verified:
Apr 1, 2020
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Part A (dose escalation in advanced cancer): LY3076226 administered intravenously (IV) on day 1 of each 21 day cycle. Part B (dose expansion in advanced urothelial carcinoma): LY3076226 administered IV on day 1 of each 21 day cycle. |
| Arm/Group Title | LY3076226-0.2mg/kg | LY3076226-0.4mg/kg | LY3076226-0.8mg/kg | LY3076226-1.6mg/kg | LY3076226-2.4mg/kg | LY3076226-3.2mg/kg | LY3076226-4.0mg/kg | LY3076226-5.0mg/kg | LY3076226-5.0mg/kg Dose Expansion |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part A cohort 1 of dose escalation of LY3076226 at 0.2 milligram per killogram (mg/kg). | Part A cohort 2 of dose escalation of LY3076226 at 0.4mg/kg. | Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg. | Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg. | Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg. | Part A cohort 6 of dose escalation of LY3076226 at 3.2mg/kg. | Part A cohort 7 of dose escalation of LY3076226 at 4.0mg/kg. | Part A cohort 8 of dose escalation of LY3076226 at 5.0mg/kg. | Part B dose expansion of LY3076226 at 5.0mg/kg. |
| Period Title: Overall Study | |||||||||
| STARTED | 1 | 1 | 1 | 3 | 3 | 4 | 3 | 6 | 3 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 1 | 1 | 1 | 3 | 3 | 4 | 3 | 6 | 3 |
Baseline Characteristics
| Arm/Group Title | LY3076226-0.2mg/kg | LY3076226-0.4mg/kg | LY3076226-0.8mg/kg | LY3076226-1.6mg/kg | LY3076226-2.4mg/kg | LY3076226-3.2mg/kg | LY3076226-4.0mg/kg | LY3076226-5.0mg/kg | LY3076226-5.0mg/kg Dose Expansion | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Part A cohort 1 of dose escalation of LY3076226 at 0.2mg/kg. | Part A cohort 2 of dose escalation of LY3076226 at 0.4mg/kg. | Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg. | Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg. | Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg. | Part A cohort 6 of dose escalation of LY3076226 at 3.2mg/kg. | Part A cohort 7 of dose escalation of LY3076226 at 4.0mg/kg. | Part A cohort 8 of dose escalation of LY3076226 at 5.0mg/kg. | Part B dose expansion of LY3076226 at 5.0mg/kg. | Total of all reporting groups |
| Overall Participants | 1 | 1 | 1 | 3 | 3 | 4 | 3 | 6 | 3 | 25 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||||
| Mean (Standard Deviation) [years] |
41.0
|
73.0
|
56.0
|
68.3
(1.5)
|
55.0
(6.2)
|
63.0
(5.5)
|
72.7
(9.8)
|
65.8
(8.7)
|
56.3
(5.9)
|
63.0
(9.5)
|
| Sex: Female, Male (Count of Participants) | ||||||||||
| Female |
0
0%
|
0
0%
|
0
0%
|
2
66.7%
|
2
66.7%
|
4
100%
|
2
66.7%
|
2
33.3%
|
1
33.3%
|
13
52%
|
| Male |
1
100%
|
1
100%
|
1
100%
|
1
33.3%
|
1
33.3%
|
0
0%
|
1
33.3%
|
4
66.7%
|
2
66.7%
|
12
48%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||||||
| Hispanic or Latino |
1
100%
|
0
0%
|
0
0%
|
1
33.3%
|
1
33.3%
|
1
25%
|
1
33.3%
|
1
16.7%
|
0
0%
|
6
24%
|
| Not Hispanic or Latino |
0
0%
|
1
100%
|
1
100%
|
2
66.7%
|
2
66.7%
|
3
75%
|
2
66.7%
|
5
83.3%
|
3
100%
|
19
76%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
33.3%
|
1
16.7%
|
0
0%
|
2
8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
1
4%
|
| White |
1
100%
|
1
100%
|
1
100%
|
3
100%
|
3
100%
|
4
100%
|
2
66.7%
|
4
66.7%
|
3
100%
|
22
88%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | ||||||||||
| Canada |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
66.7%
|
1
25%
|
1
33.3%
|
1
16.7%
|
2
66.7%
|
7
28%
|
| United States |
1
100%
|
1
100%
|
1
100%
|
3
100%
|
1
33.3%
|
3
75%
|
2
66.7%
|
5
83.3%
|
1
33.3%
|
18
72%
|
Outcome Measures
| Title | Maximum Tolerated Dose (MTD) of LY3076226 |
|---|---|
| Description | The MTD was defined as the highest dose tested that had less than 33% probability of causing a dose limiting toxicity (DLT). |
| Time Frame | Cycle 1 (21 Days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants enrolled in dose escalation. |
| Arm/Group Title | LY3076226 |
|---|---|
| Arm/Group Description | Part A dose escalation of LY3076226 administered intravenously (IV) on day 1 of cycle 1. |
| Measure Participants | 22 |
| Number [milligrams] |
5.0
|
| Title | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3076226 |
|---|---|
| Description | |
| Time Frame | Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants with adequate measurable PK concentrations. |
| Arm/Group Title | LY3076226-0.2mg/kg | LY3076226-0.4mg/kg | LY3076226-0.8mg/kg | LY3076226-1.6mg/kg | LY3076226-2.4mg/kg | LY3076226-3.2mg/kg | LY3076226-4.0mg/kg | LY3076226-5.0mg/kg | LY3076226-5.0mg/kg Dose Expansion |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Cohort 1 of dose escalation of LY3076226 at 0.2 mg/kg. | Cohort 2 of dose escalation of LY3076226 at 0.4mg/kg. | Cohort 3 of dose escalation of LY3076226 at 0.8mg/kg. | Cohort 4 of dose escalation of LY3076226 at 1.6mg/kg. | Cohort 5 of dose escalation of LY3076226 at 2.4mg/kg. | Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg. | Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg. | Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg. | Dose expansion of LY3076226 at 5.0mg/kg. |
| Measure Participants | 1 | 1 | 1 | 3 | 3 | 4 | 3 | 6 | 3 |
| Cycle 1 |
5.35
|
10.6
|
23.3
|
41.9
(22.2)
|
133
(123)
|
77.4
(20.5)
|
104
(9.37)
|
119
(16.2)
|
101
(22.3)
|
| Cycle 3 |
62.0
(34.0)
|
89.8
(100)
|
105
(8.26)
|
144
(5.60)
|
95.7
(22.1)
|
| Title | PK: Area Under the Concentration-Time Curve (AUC) of LY3076226 |
|---|---|
| Description | |
| Time Frame | Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants with adequate measurable PK concentrations. |
| Arm/Group Title | LY3076226-0.2mg/kg | LY3076226-0.4mg/kg | LY3076226-0.8mg/kg | LY3076226-1.6mg/kg | LY3076226-2.4mg/kg | LY3076226-3.2mg/kg | LY3076226-4.0mg/kg | LY3076226-5.0mg/kg | LY3076226-5.0mg/kg Dose Expansion |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Cohort 1 of dose escalation of LY3076226 at 0.2 mg/kg. | Cohort 2 of dose escalation of LY3076226 at 0.4mg/kg. | Cohort 3 of dose escalation of LY3076226 at 0.8mg/kg. | Cohort 4 of dose escalation of LY3076226 at 1.6mg/kg. | Cohort 5 of dose escalation of LY3076226 at 2.4mg/kg. | Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg. | Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg. | Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg. | Dose expansion of LY3076226 at 5.0mg/kg. |
| Measure Participants | 1 | 1 | 1 | 3 | 3 | 4 | 3 | 6 | 3 |
| Cycle 1 |
13.0
|
18.8
|
112
|
223
(14.3)
|
503
(55.5)
|
424
(33.2)
|
665
(14.0)
|
664
(29.5)
|
638
(17.1)
|
| Cycle 3 |
374
(78.2)
|
758
(833)
|
688
(41.2)
|
1120
(18.9)
|
801
(27.0)
|
| Title | Number of Participants With Tumor Response |
|---|---|
| Description | Tumor response was assessed using confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). Complete response (CR) was the disappearance of all target and non-target lesions and normalization of tumor marker levels of non-target lesions; partial response (PR) was at least a 30% decrease in the sum of the longest diameter of target lesions. |
| Time Frame | Baseline through Study Completion (Cycle 3, day 21) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | LY3076226-0.2mg/kg | LY3076226-0.4mg/kg | LY3076226-0.8mg/kg | LY3076226-1.6mg/kg | LY3076226-2.4mg/kg | LY3076226-3.2mg/kg | LY3076226-4.0mg/kg | LY3076226-5.0mg/kg | LY3076226-5.0mg/kg Dose Expansion |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Cohort 1 of dose escalation of LY3076226 at 0.2 mg/kg. | Cohort 2 of dose escalation of LY3076226 at 0.4mg/kg. | Cohort 3 of dose escalation of LY3076226 at 0.8mg/kg. | Cohort 4 of dose escalation of LY3076226 at 1.6mg/kg. | Cohort 5 of dose escalation of LY3076226 at 2.4mg/kg. | Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg. | Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg. | Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg. | Dose expansion of LY3076226 at 5.0mg/kg. |
| Measure Participants | 1 | 1 | 1 | 3 | 3 | 4 | 3 | 6 | 3 |
| Number [participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Up To 33 Days post study treatment | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All participants who received at least one dose of study drug. | |||||||||||||||||
| Arm/Group Title | LY3076226-0.2mg/kg | LY3076226-0.4mg/kg | LY3076226-0.8mg/kg | LY3076226-1.6mg/kg | LY3076226-2.4mg/kg | LY3076226-3.2mg/kg | LY3076226-4.0mg/kg | LY3076226-5.0mg/kg | LY3076226-5.0mg/kg Dose Expansion | |||||||||
| Arm/Group Description | Part A cohort 1 of dose escalation of LY3076226 at 0.2mg/kg. | Part A cohort 2 of dose escalation of LY3076226 at 0.4mg/kg. | Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg. | Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg. | Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg. | Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg. | Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg. | Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg. | Part B dose expansion of LY3076226 at 5.0mg/kg. | |||||||||
All Cause Mortality |
||||||||||||||||||
| LY3076226-0.2mg/kg | LY3076226-0.4mg/kg | LY3076226-0.8mg/kg | LY3076226-1.6mg/kg | LY3076226-2.4mg/kg | LY3076226-3.2mg/kg | LY3076226-4.0mg/kg | LY3076226-5.0mg/kg | LY3076226-5.0mg/kg Dose Expansion | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | |||||||||
Serious Adverse Events |
||||||||||||||||||
| LY3076226-0.2mg/kg | LY3076226-0.4mg/kg | LY3076226-0.8mg/kg | LY3076226-1.6mg/kg | LY3076226-2.4mg/kg | LY3076226-3.2mg/kg | LY3076226-4.0mg/kg | LY3076226-5.0mg/kg | LY3076226-5.0mg/kg Dose Expansion | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 1/1 (100%) | 0/1 (0%) | 1/3 (33.3%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 1/6 (16.7%) | 0/3 (0%) | |||||||||
| Gastrointestinal disorders | ||||||||||||||||||
| Small intestinal obstruction | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||
| Kidney infection | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||
| Fall | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||||
| Hypokalaemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||||||
| Acute kidney injury | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 2 | 0/3 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| LY3076226-0.2mg/kg | LY3076226-0.4mg/kg | LY3076226-0.8mg/kg | LY3076226-1.6mg/kg | LY3076226-2.4mg/kg | LY3076226-3.2mg/kg | LY3076226-4.0mg/kg | LY3076226-5.0mg/kg | LY3076226-5.0mg/kg Dose Expansion | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) | 3/3 (100%) | 3/3 (100%) | 4/4 (100%) | 3/3 (100%) | 6/6 (100%) | 3/3 (100%) | |||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||
| Anaemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 1/3 (33.3%) | 1 |
| Cardiac disorders | ||||||||||||||||||
| Atrial fibrillation | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Sinus bradycardia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Sinus tachycardia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Eye disorders | ||||||||||||||||||
| Corneal epithelial microcysts | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 |
| Dry eye | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Keratitis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Photopsia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 2 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Retinal pigment epitheliopathy | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Vision blurred | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/4 (0%) | 0 | 1/3 (33.3%) | 2 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||
| Abdominal distension | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Abdominal pain | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 1/1 (100%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 2 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Ascites | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Constipation | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 0/3 (0%) | 0 |
| Diarrhoea | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 3 | 1/4 (25%) | 1 | 3/3 (100%) | 6 | 4/6 (66.7%) | 4 | 0/3 (0%) | 0 |
| Dry mouth | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Dysphagia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Eructation | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Gastritis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Gastrooesophageal reflux disease | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/4 (50%) | 2 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Nausea | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 2/3 (66.7%) | 3 | 3/3 (100%) | 3 | 2/4 (50%) | 2 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 2/3 (66.7%) | 8 |
| Oesophageal pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Rectal discharge | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Rectal haemorrhage | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Stomatitis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Vomiting | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/3 (33.3%) | 2 |
| General disorders | ||||||||||||||||||
| Chest discomfort | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Chills | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 2 | 1/6 (16.7%) | 2 | 0/3 (0%) | 0 |
| Early satiety | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Fatigue | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 2/3 (66.7%) | 2 | 1/3 (33.3%) | 1 | 2/4 (50%) | 2 | 3/3 (100%) | 4 | 0/6 (0%) | 0 | 2/3 (66.7%) | 3 |
| Non-cardiac chest pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Oedema peripheral | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Pyrexia | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||
| Cystitis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 1/3 (33.3%) | 1 |
| Nasal vestibulitis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Oral candidiasis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Pharyngitis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Sepsis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Skin infection | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Urinary tract infection | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 0/3 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||
| Fall | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Ligament sprain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Thermal burn | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Investigations | ||||||||||||||||||
| Alanine aminotransferase increased | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Aspartate aminotransferase increased | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 3/6 (50%) | 3 | 1/3 (33.3%) | 1 |
| Blood alkaline phosphatase increased | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/3 (33.3%) | 2 |
| Blood bilirubin increased | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Blood creatinine increased | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Platelet count decreased | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 2/3 (66.7%) | 3 |
| Weight decreased | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 2 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||||
| Decreased appetite | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 2/3 (66.7%) | 2 | 1/6 (16.7%) | 2 | 1/3 (33.3%) | 2 |
| Dehydration | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Hypercalcaemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/3 (33.3%) | 1 |
| Hyperglycaemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Hyperkalaemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Hypoalbuminaemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 2 | 0/3 (0%) | 0 |
| Hypokalaemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Hypomagnesaemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Hyponatraemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Hypophosphataemia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| Arthritis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 0/3 (0%) | 0 |
| Back pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Muscular weakness | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Musculoskeletal chest pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Myalgia | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 1/1 (100%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Pain in extremity | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||
| Tumour pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 |
| Nervous system disorders | ||||||||||||||||||
| Dysaesthesia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/4 (50%) | 2 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Dysgeusia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Headache | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 2 | 0/4 (0%) | 0 | 2/3 (66.7%) | 3 | 1/6 (16.7%) | 2 | 0/3 (0%) | 0 |
| Neuralgia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Paraesthesia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 |
| Peripheral motor neuropathy | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Peripheral sensory neuropathy | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 2 | 1/3 (33.3%) | 1 |
| Spinal cord compression | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Syncope | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Tremor | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||||||
| Anxiety | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Confusional state | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Depression | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||||||
| Acute kidney injury | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Chromaturia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Haematuria | 0/1 (0%) | 0 | 1/1 (100%) | 2 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Urinary retention | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Cough | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Dysphonia | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/3 (33.3%) | 1 |
| Dyspnoea | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 1/3 (33.3%) | 1 |
| Hiccups | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Nasal congestion | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Oropharyngeal pain | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Pleural effusion | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 2/3 (66.7%) | 2 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Productive cough | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Pulmonary haemorrhage | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 |
| Rhinitis allergic | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Upper-airway cough syndrome | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Wheezing | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||
| Dermatitis contact | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 2 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Dry skin | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 |
| Hyperhidrosis | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Photosensitivity reaction | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 2 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Pruritus | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Rash maculo-papular | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 2/3 (66.7%) | 2 | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 |
| Skin hyperpigmentation | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 2 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Vascular disorders | ||||||||||||||||||
| Embolism | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Hot flush | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Hypertension | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 2/6 (33.3%) | 3 | 0/3 (0%) | 0 |
Limitations/Caveats
Due to pipeline reprioritization, development of LY3076226 was discontinued at the end of 2017 and no further patients were enrolled.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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:
NCT02529553
Other Study ID Numbers:
- 15383
- I7O-MC-JOBA
First Posted:
Aug 20, 2015
Last Update Posted:
Apr 17, 2020
Last Verified:
Apr 1, 2020