Trial Outcomes & Findings for A Drug Interaction Study to Assess the Effect of LY2603618 on the Metabolic Pathway of Desipramine (NCT NCT01358968)
NCT ID: NCT01358968
Last Updated: 2018-10-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Period 2 only: Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose
Results posted on
2018-10-25
Participant Flow
This was a nonrandomized, open-label, fixed-sequence, 2-period study followed by a continued access phase.
Participant milestones
| Measure |
Desipramine (Period 1)
Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.
|
LY2603618 + Desipramine (Period 2)
Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.
|
LY2603618 + Gemcitabine (Continued Access)
1000-milligrams per square meter (mg/m²) intravenous administration over 30 minutes of gemcitabine on Days 1, 8 and 15 and 230-mg intravenous infusion over one hour of LY2603618 on Days 2, 9 and 16 of 28-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
LY2603618 + Pemetrexed (Continued Access)
500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
20
|
0
|
0
|
0
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
20
|
0
|
0
|
0
|
|
Period 1
COMPLETED
|
20
|
0
|
0
|
0
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
0
|
20
|
0
|
0
|
|
Period 2
Received at Least 1 Dose of Study Drug
|
0
|
19
|
0
|
0
|
|
Period 2
COMPLETED
|
0
|
19
|
0
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Continued Access Phase
STARTED
|
0
|
0
|
12
|
7
|
|
Continued Access Phase
Received at Least 1 Dose of Study Drug
|
0
|
0
|
12
|
7
|
|
Continued Access Phase
COMPLETED
|
0
|
0
|
0
|
0
|
|
Continued Access Phase
NOT COMPLETED
|
0
|
0
|
12
|
7
|
Reasons for withdrawal
| Measure |
Desipramine (Period 1)
Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.
|
LY2603618 + Desipramine (Period 2)
Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.
|
LY2603618 + Gemcitabine (Continued Access)
1000-milligrams per square meter (mg/m²) intravenous administration over 30 minutes of gemcitabine on Days 1, 8 and 15 and 230-mg intravenous infusion over one hour of LY2603618 on Days 2, 9 and 16 of 28-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
LY2603618 + Pemetrexed (Continued Access)
500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
|---|---|---|---|---|
|
Period 2
Adverse Event
|
0
|
1
|
0
|
0
|
|
Continued Access Phase
Progression of Disease
|
0
|
0
|
8
|
4
|
|
Continued Access Phase
Protocol Violation
|
0
|
0
|
0
|
2
|
|
Continued Access Phase
Withdrawal by Subject
|
0
|
0
|
3
|
0
|
|
Continued Access Phase
Death
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Drug Interaction Study to Assess the Effect of LY2603618 on the Metabolic Pathway of Desipramine
Baseline characteristics by cohort
| Measure |
All Participants
n=20 Participants
Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1. Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.
Participants may have received additional doses of LY2603618 in combination as follows: 1000 milligrams per square meter (mg/m²) intravenous administration over 30 minutes of gemcitabine on Days 1, 8 and 15 and 230-mg intravenous infusion over one hour of LY2603618 on Days 2, 9 and 16 of 28-day cycles during continued access phase OR 500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Period 2 only: Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dosePopulation: All participants who received LY2603618 and had pharmacokinetic data collected to calculate the Cmax of LY2603618 in Period 2.
Outcome measures
| Measure |
LY2603618
n=19 Participants
Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.
Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.
|
LY2603618 + Pemetrexed (Continued Access)
500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
|---|---|---|
|
Plasma Pharmacokinetics of LY2603618: the Maximum Concentration of LY2603618 in the Plasma (Cmax)
|
5950 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
—
|
PRIMARY outcome
Timeframe: Periods 1 and 2: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dosePopulation: All participants who received desipramine and had pharmacokinetic data collected to calculate the Cmax of desipramine in Periods 1 and 2.
Outcome measures
| Measure |
LY2603618
n=20 Participants
Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.
Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.
|
LY2603618 + Pemetrexed (Continued Access)
500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
|---|---|---|
|
Plasma Pharmacokinetics of Desipramine: the Maximum Concentration of Desipramine in the Plasma (Cmax)
Period 1
|
21.2 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 67
|
—
|
|
Plasma Pharmacokinetics of Desipramine: the Maximum Concentration of Desipramine in the Plasma (Cmax)
Period 2
|
22.8 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 62
|
—
|
PRIMARY outcome
Timeframe: Period 2 only: Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dosePopulation: All participants who received LY2603618 and had pharmacokinetic data collected to calculate the AUC(0-∞) of LY2603618 in Period 2.
Outcome measures
| Measure |
LY2603618
n=19 Participants
Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.
Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.
|
LY2603618 + Pemetrexed (Continued Access)
500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
|---|---|---|
|
Plasma Pharmacokinetics of LY2603618: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)]
|
53700 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 55
|
—
|
PRIMARY outcome
Timeframe: Periods 1 and 2: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dosePopulation: All participants who received desipramine and had pharmacokinetic data collected to calculate the AUC(0-∞) of desipramine in Periods 1 and 2.
Outcome measures
| Measure |
LY2603618
n=20 Participants
Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.
Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.
|
LY2603618 + Pemetrexed (Continued Access)
500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
|---|---|---|
|
Plasma Pharmacokinetics of Desipramine: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)]
Period 1
|
655 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 84
|
—
|
|
Plasma Pharmacokinetics of Desipramine: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)]
Period 2
|
687 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 80
|
—
|
PRIMARY outcome
Timeframe: Period 2 only: Predose 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dosePopulation: All participants who received LY2603618 and had pharmacokinetic data collected to calculate the AUC(0-tlast) of LY2603618 in Period 2.
Outcome measures
| Measure |
LY2603618
n=19 Participants
Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.
Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.
|
LY2603618 + Pemetrexed (Continued Access)
500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
|---|---|---|
|
Plasma Pharmacokinetics of LY2603618: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Observed Plasma Concentration of LY2603618 [AUC(0-tlast)]
|
53000 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 52
|
—
|
PRIMARY outcome
Timeframe: Periods 1 and 2: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dosePopulation: All participants who received desipramine and had pharmacokinetic data collected to calculate AUC(0-tlast) of desipramine in Periods 1 and 2.
Outcome measures
| Measure |
LY2603618
n=20 Participants
Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.
Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.
|
LY2603618 + Pemetrexed (Continued Access)
500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
|---|---|---|
|
Plasma Pharmacokinetics of Desipramine: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Observed Plasma Concentration of Desipramine [AUC(0-tlast)]
Period 1
|
619 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 76
|
—
|
|
Plasma Pharmacokinetics of Desipramine: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Observed Plasma Concentration of Desipramine [AUC(0-tlast)]
Period 2
|
653 nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 72
|
—
|
SECONDARY outcome
Timeframe: Baseline to study completion up to 11 cycles of 21-day cyclesPopulation: All participants who received at least 1 dose of study drug and had tumor response measured during continued access phase.
Tumor response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1). CR is the disappearance of all target and non-target lesions and PR is a ≥30% decrease in sum of longest diameter of target lesions. Number of participants with a tumor response is the total number of participants with CR or PR.
Outcome measures
| Measure |
LY2603618
n=9 Participants
Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.
Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.
|
LY2603618 + Pemetrexed (Continued Access)
n=6 Participants
500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
|---|---|---|
|
Number of Participants With a Tumor Response
|
1 Participants
|
0 Participants
|
Adverse Events
Desipramine (Period 1)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
LY2603618 + Desipramine (Period 2)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
LY2603618 + Gemcitabine (Continued Access)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
LY2603618 + Pemetrexed (Continued Access)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Desipramine (Period 1)
n=20 participants at risk
Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.
|
LY2603618 + Desipramine (Period 2)
n=19 participants at risk
Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.
|
LY2603618 + Gemcitabine (Continued Access)
n=12 participants at risk
1000-milligrams per square meter (mg/m²) intravenous administration over 30 minutes of gemcitabine on Days 1, 8 and 15 and 230-mg intravenous infusion over one hour of LY2603618 on Days 2, 9 and 16 of 28-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
LY2603618 + Pemetrexed (Continued Access)
n=7 participants at risk
500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Device related infection
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Vascular disorders
Embolism
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
Other adverse events
| Measure |
Desipramine (Period 1)
n=20 participants at risk
Single 50-milligram (mg) oral dose of desipramine on Day 1 of Study Period 1.
|
LY2603618 + Desipramine (Period 2)
n=19 participants at risk
Single 275-mg intravenous infusion over one hour of LY2603618 followed by single 50-mg oral dose of desipramine on Day 1 of Study Period 2.
|
LY2603618 + Gemcitabine (Continued Access)
n=12 participants at risk
1000-milligrams per square meter (mg/m²) intravenous administration over 30 minutes of gemcitabine on Days 1, 8 and 15 and 230-mg intravenous infusion over one hour of LY2603618 on Days 2, 9 and 16 of 28-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
LY2603618 + Pemetrexed (Continued Access)
n=7 participants at risk
500-mg/m² intravenous administration over 10 minutes of pemetrexed on Day 1 and 275-mg intravenous infusion over one hour of LY2603618 on Day 2 of 21-day cycles during continued access phase.
Participants were allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
50.0%
6/12 • Number of events 6
|
28.6%
2/7 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/20
|
0.00%
0/19
|
66.7%
8/12 • Number of events 11
|
14.3%
1/7 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
33.3%
4/12 • Number of events 6
|
28.6%
2/7 • Number of events 2
|
|
Cardiac disorders
Palpitations
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20
|
5.3%
1/19 • Number of events 2
|
0.00%
0/12
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20
|
0.00%
0/19
|
33.3%
4/12 • Number of events 6
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20
|
10.5%
2/19 • Number of events 2
|
50.0%
6/12 • Number of events 8
|
42.9%
3/7 • Number of events 4
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1
|
26.3%
5/19 • Number of events 6
|
41.7%
5/12 • Number of events 7
|
71.4%
5/7 • Number of events 9
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Paraesthesia oral
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
0.00%
0/12
|
0.00%
0/7
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/20
|
0.00%
0/19
|
25.0%
3/12 • Number of events 3
|
28.6%
2/7 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1
|
15.8%
3/19 • Number of events 4
|
41.7%
5/12 • Number of events 12
|
42.9%
3/7 • Number of events 5
|
|
General disorders
Chest discomfort
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Disease progression
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 2
|
0.00%
0/7
|
|
General disorders
Fatigue
|
0.00%
0/20
|
10.5%
2/19 • Number of events 2
|
75.0%
9/12 • Number of events 11
|
71.4%
5/7 • Number of events 7
|
|
General disorders
Injection site reaction
|
0.00%
0/20
|
21.1%
4/19 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Oedema peripheral
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
28.6%
2/7 • Number of events 3
|
|
General disorders
Pain
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
33.3%
4/12 • Number of events 9
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Infection
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/12
|
0.00%
0/7
|
|
Infections and infestations
Lung infection
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20
|
0.00%
0/19
|
16.7%
2/12 • Number of events 2
|
0.00%
0/7
|
|
Infections and infestations
Sinusitis
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/12
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/20
|
21.1%
4/19 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/12
|
0.00%
0/7
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/20
|
10.5%
2/19 • Number of events 2
|
33.3%
4/12 • Number of events 4
|
0.00%
0/7
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
2/20 • Number of events 2
|
0.00%
0/19
|
33.3%
4/12 • Number of events 4
|
0.00%
0/7
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Blood creatinine increased
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Investigations
International normalised ratio increased
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Weight decreased
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
|
Investigations
Weight increased
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
42.9%
3/7 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
28.6%
2/7 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/20
|
0.00%
0/19
|
25.0%
3/12 • Number of events 5
|
28.6%
2/7 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20
|
0.00%
0/19
|
16.7%
2/12 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20
|
0.00%
0/19
|
16.7%
2/12 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Syncope
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/12
|
0.00%
0/7
|
|
Nervous system disorders
Tremor
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/12
|
0.00%
0/7
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/12
|
0.00%
0/7
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Depression
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20
|
0.00%
0/19
|
16.7%
2/12 • Number of events 2
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/20
|
0.00%
0/19
|
8.3%
1/12 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/20
|
0.00%
0/19
|
0.00%
0/12
|
14.3%
1/7 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/20
|
0.00%
0/19
|
16.7%
2/12 • Number of events 2
|
14.3%
1/7 • Number of events 2
|
|
Vascular disorders
Phlebitis
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
0.00%
0/12
|
0.00%
0/7
|
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