Trial Outcomes & Findings for A Study of LY3007113 in Participants With Advanced Cancer (NCT NCT01463631)
NCT ID: NCT01463631
Last Updated: 2018-08-07
Results Overview
Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after randomization. A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Baseline through Study Completion (up to 170 Days)
Results posted on
2018-08-07
Participant Flow
For cohorts 1-3, participants completed the trial if they received at least 75% of planned doses of LY3007113 and completed at least 1 cycle. For Part B, participants completed the trial if they completed at least 2 cycles of study treatment and were assessed for response. (Cycle = 28 days.)
Participant milestones
| Measure |
20 mg LY3007113 (Cohort 1)
20 milligrams (mg) LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
40 mg LY3007113 (Cohort 2)
40 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Cohort 3)
30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Part B)
30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
5
|
15
|
|
Overall Study
Received at Least One Dose of Study Drug
|
3
|
4
|
5
|
15
|
|
Overall Study
COMPLETED
|
3
|
4
|
4
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
6
|
Reasons for withdrawal
| Measure |
20 mg LY3007113 (Cohort 1)
20 milligrams (mg) LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
40 mg LY3007113 (Cohort 2)
40 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Cohort 3)
30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Part B)
30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Progressive Disease
|
0
|
0
|
0
|
5
|
Baseline Characteristics
A Study of LY3007113 in Participants With Advanced Cancer
Baseline characteristics by cohort
| Measure |
20 mg LY3007113 (Cohort 1)
n=3 Participants
20 mg LY3007113 administered once orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
|
40 mg LY3007113 (Cohort 2)
n=4 Participants
40 mg LY3007113 administered once orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Cohort 3)
n=5 Participants
30 mg LY3007113 administered once orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Part B)
n=15 Participants
30 mg LY3007113 administered once orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline through Study Completion (up to 170 Days)Population: Participants who received at least one dose of study drug.
Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after randomization. A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Outcome measures
| Measure |
20 mg LY3007113 (Cohort 1)
n=3 Participants
20 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
40 mg LY3007113 (Cohort 2)
n=4 Participants
40 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Cohort 3)
n=5 Participants
30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Part B)
n=15 Participants
30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Adverse Events (AEs) (Physical Assessments and Clinical Lab Tests)
|
2 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline through Study Completion (up to 170 Days)Population: Participants in Part B who received at least one dose of study drug and were radiologically assessed for tumor response.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter without notable worsening of additional tumors that were qualitatively assessed.
Outcome measures
| Measure |
20 mg LY3007113 (Cohort 1)
n=13 Participants
20 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
40 mg LY3007113 (Cohort 2)
40 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Cohort 3)
30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Part B)
30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
|---|---|---|---|---|
|
The Percentage of Participants Who Achieved a Best Response of Either Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
CR
|
0 percentage of participants
|
—
|
—
|
—
|
|
The Percentage of Participants Who Achieved a Best Response of Either Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
PR
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days -3, -2, -1, 1: Predose to 48 hours PostdosePopulation: Participants who received at least one dose of study drug and had sufficient evaluable AUC(0-inf) values.
Outcome measures
| Measure |
20 mg LY3007113 (Cohort 1)
n=3 Participants
20 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
40 mg LY3007113 (Cohort 2)
n=4 Participants
40 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Cohort 3)
n=18 Participants
30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Part B)
30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of Single Dose LY3007113
|
1560 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 25
|
2480 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 32
|
1810 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 67
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days 28 and 29, Cycle 2 Day 1: Predose to 24 hours PostdosePopulation: Participants who received at least one dose of study drug and had sufficient evaluable AUC(0-tau) values.
Outcome measures
| Measure |
20 mg LY3007113 (Cohort 1)
n=3 Participants
20 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
40 mg LY3007113 (Cohort 2)
n=4 Participants
40 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Cohort 3)
n=12 Participants
30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Part B)
30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From 0 to Tau (AUC[0-tau]) of Multiple Dose LY3007113
|
1360 ng*hr/mL
Geometric Coefficient of Variation 23
|
3260 ng*hr/mL
Geometric Coefficient of Variation 46
|
2070 ng*hr/mL
Geometric Coefficient of Variation 68
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day -3 (single dose): Predose to 48 hours Postdose; Day 28 (multiple dose): Predose to 24 hours PostdosePopulation: Participants who received at least one dose of study drug and had sufficient evaluable Cmax values.
Outcome measures
| Measure |
20 mg LY3007113 (Cohort 1)
n=3 Participants
20 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
40 mg LY3007113 (Cohort 2)
n=4 Participants
40 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Cohort 3)
n=18 Participants
30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Part B)
30 mg LY3007113 administered orally once every 12 hours on Days 1 through 28. (28-day cycle.) Participants received 2 cycles of treatment. Participants may have received more than 2 cycles of treatment if discontinuation criteria were not met and there was evidence of clinical benefit.
|
|---|---|---|---|---|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3007113
Multiple dose
|
178 ng/mL
Geometric Coefficient of Variation 31
|
489 ng/mL
Geometric Coefficient of Variation 31
|
386 ng/mL
Geometric Coefficient of Variation 64
|
—
|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3007113
Single dose
|
197 ng/mL
Geometric Coefficient of Variation 3
|
296 ng/mL
Geometric Coefficient of Variation 66
|
247 ng/mL
Geometric Coefficient of Variation 49
|
—
|
Adverse Events
20 mg LY3007113 (Cohort 1)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
40 mg LY3007113 (Cohort 2)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
30 mg LY3007113 (Cohort 3)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
30 mg LY3007113 (Part B)
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
20 mg LY3007113 (Cohort 1)
n=3 participants at risk
20 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
|
40 mg LY3007113 (Cohort 2)
n=4 participants at risk
40 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Cohort 3)
n=5 participants at risk
30 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Part B)
n=15 participants at risk
30 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
|
|---|---|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Peptic ulcer
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
0.00%
0/15
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 2
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
|
Nervous system disorders
Convulsion
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
Other adverse events
| Measure |
20 mg LY3007113 (Cohort 1)
n=3 participants at risk
20 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
|
40 mg LY3007113 (Cohort 2)
n=4 participants at risk
40 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Cohort 3)
n=5 participants at risk
30 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
|
30 mg LY3007113 (Part B)
n=15 participants at risk
30 mg LY3007113 administered orally every 12 hours on Days 1 through 28. (28-day cycle.) Participants may have continued to receive study drug if discontinuation criterion was not met and there was evidence of clinical benefit.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
40.0%
2/5 • Number of events 2
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
0.00%
0/15
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
0.00%
0/15
|
|
Eye disorders
Photophobia
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
60.0%
3/5 • Number of events 3
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/5
|
0.00%
0/15
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/4
|
40.0%
2/5 • Number of events 2
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
Peptic ulcer
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
40.0%
2/5 • Number of events 4
|
6.7%
1/15 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
13.3%
2/15 • Number of events 3
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 2
|
50.0%
2/4 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
26.7%
4/15 • Number of events 4
|
|
General disorders
Feeling jittery
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3
|
0.00%
0/4
|
40.0%
2/5 • Number of events 2
|
0.00%
0/15
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
20.0%
3/15 • Number of events 3
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
Lip infection
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Incision site rash
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
0.00%
0/15
|
|
Investigations
Blood creatine phosphokinase increased
|
33.3%
1/3 • Number of events 1
|
50.0%
2/4 • Number of events 4
|
0.00%
0/5
|
0.00%
0/15
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
0.00%
0/15
|
|
Investigations
Platelet count decreased
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Weight decreased
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/5
|
0.00%
0/15
|
|
Nervous system disorders
Tremor
|
0.00%
0/3
|
75.0%
3/4 • Number of events 7
|
20.0%
1/5 • Number of events 1
|
46.7%
7/15 • Number of events 8
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
13.3%
2/15 • Number of events 2
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
40.0%
2/5 • Number of events 2
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
13.3%
2/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
0.00%
0/4
|
40.0%
2/5 • Number of events 2
|
20.0%
3/15 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
13.3%
2/15 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
0.00%
0/5
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/5
|
0.00%
0/15
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
0.00%
0/15
|
|
Vascular disorders
Hot flush
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/5
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 2
|
0.00%
0/4
|
20.0%
1/5 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60