Trial Outcomes & Findings for A Phase 1b Trial in Patients With Renal Cell Cancer (NCT NCT01258348)
NCT ID: NCT01258348
Last Updated: 2019-01-10
Results Overview
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose with \<33% of participants having a dose-limiting toxicity (DLT) during the first 6-week cycle of treatment. DLT is an adverse event (AE) that is likely related to study drug or combination and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 neutropenia lasting ≥5 days; Gr 4 neutropenia with fever; Gr 4 thrombocytopenia; Gr ≥3 thrombocytopenia with bleeding; Gr ≥3 nonhematologic toxicity (excluding controllable nausea/vomiting or diarrhea and alopecia); Gr 3 electrolyte toxicity that is not resolved with standard treatments; Gr ≥3 elevated hepatic enzyme abnormalities in the setting of preexisting hepatic metastasis may not be considered a DLT; a DLT can be declared if a participant experiences increasing toxicity during treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
Predose up to 42 days postdose in Cycle 1 (6 weeks per cycle)
Results posted on
2019-01-10
Participant Flow
The reasons for discontinuation listed in the Participant Flow are the reasons the participant discontinued treatment. All participants who received at least 1 dose of study drug were considered to have completed the study.
Participant milestones
| Measure |
LY 340 μg/mL + Sunitinib 50 mg
LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing.
|
LY 300 μg/mL + Sunitinib 50/37.5 mg
LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks .
|
LY 320 μg/mL + Sunitinib 37.5 mg
LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 340 μg/mL + Sunitinib 37.5 mg
LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 360 μg/mL + Sunitinib 37.5 mg
LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
5
|
3
|
6
|
6
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
1
|
5
|
3
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
3
|
6
|
6
|
Reasons for withdrawal
| Measure |
LY 340 μg/mL + Sunitinib 50 mg
LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing.
|
LY 300 μg/mL + Sunitinib 50/37.5 mg
LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks .
|
LY 320 μg/mL + Sunitinib 37.5 mg
LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 340 μg/mL + Sunitinib 37.5 mg
LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 360 μg/mL + Sunitinib 37.5 mg
LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
3
|
2
|
4
|
|
Overall Study
Progressive Disease
|
0
|
3
|
0
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 1b Trial in Patients With Renal Cell Cancer
Baseline characteristics by cohort
| Measure |
All Participants
n=21 Participants
LY573636 dose was to target a specific maximum concentration (Cmax) as a 2-hour infusion on Days 4 and 25 or Day 4 of a 6-week cycle. Sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks.
|
|---|---|
|
Age, Continuous
|
61.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · East Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose up to 42 days postdose in Cycle 1 (6 weeks per cycle)Population: All participants who received at least one dose of study drug.
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose with \<33% of participants having a dose-limiting toxicity (DLT) during the first 6-week cycle of treatment. DLT is an adverse event (AE) that is likely related to study drug or combination and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 neutropenia lasting ≥5 days; Gr 4 neutropenia with fever; Gr 4 thrombocytopenia; Gr ≥3 thrombocytopenia with bleeding; Gr ≥3 nonhematologic toxicity (excluding controllable nausea/vomiting or diarrhea and alopecia); Gr 3 electrolyte toxicity that is not resolved with standard treatments; Gr ≥3 elevated hepatic enzyme abnormalities in the setting of preexisting hepatic metastasis may not be considered a DLT; a DLT can be declared if a participant experiences increasing toxicity during treatment.
Outcome measures
| Measure |
LY 340 μg/mL + Sunitinib 50 mg
n=1 Participants
LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing.
|
LY 300 μg/mL + Sunitinib 50/37.5 mg
n=5 Participants
LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks .
|
LY 320 μg/mL + Sunitinib 37.5 mg
n=3 Participants
LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 340 μg/mL + Sunitinib 37.5 mg
n=6 Participants
LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 360 μg/mL + Sunitinib 37.5 mg
n=6 Participants
LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
|---|---|---|---|---|---|
|
Recommended Dose for Phase 2 Studies of LY573636-Sodium Combined With Sunitinib in Participants With Metastatic Renal Cell Carcinoma
|
NA micrograms per milliliter (μg/mL)
MTD was not reached because the enrollment was stopped early.
|
NA micrograms per milliliter (μg/mL)
MTD was not reached because the enrollment was stopped early.
|
NA micrograms per milliliter (μg/mL)
MTD was not reached because the enrollment was stopped early.
|
NA micrograms per milliliter (μg/mL)
MTD was not reached because the enrollment was stopped early.
|
NA micrograms per milliliter (μg/mL)
MTD was not reached because the enrollment was stopped early.
|
SECONDARY outcome
Timeframe: Predose up to 2 hours postdose in Cycles 1 and 2 (6 weeks per cycle)Population: Participants who received study drug and had sufficient pharmacokinetic (PK) data to estimate Cmax at the specified time points.
Time frame: Cycle 1:day 4: pre-dose, start of infusion, end of infusion,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion, day 25: predose, during infusion, end of infusion,30min,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion.
Outcome measures
| Measure |
LY 340 μg/mL + Sunitinib 50 mg
n=21 Participants
LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing.
|
LY 300 μg/mL + Sunitinib 50/37.5 mg
LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks .
|
LY 320 μg/mL + Sunitinib 37.5 mg
LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 340 μg/mL + Sunitinib 37.5 mg
LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 360 μg/mL + Sunitinib 37.5 mg
LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
Cycle 1
|
343.9 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 10.7
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636
Cycle 2
|
341.3 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 16.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to end of treatment up to 66 weeksPopulation: All participants who received at least one dose of study drug.
Tumor response was assessed by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. Number of participants with tumor responses = number of participants with complete response (CR) + number of participants with partial response (PR). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.
Outcome measures
| Measure |
LY 340 μg/mL + Sunitinib 50 mg
n=1 Participants
LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing.
|
LY 300 μg/mL + Sunitinib 50/37.5 mg
n=5 Participants
LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks .
|
LY 320 μg/mL + Sunitinib 37.5 mg
n=3 Participants
LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 340 μg/mL + Sunitinib 37.5 mg
n=6 Participants
LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 360 μg/mL + Sunitinib 37.5 mg
n=6 Participants
LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Tumor Responses
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1 to 42 in Cycle 1 (6 weeks per cycle)Population: Participants who received sunitinib and had sufficient pharmacokinetic (PK) data to calculate AUC.
Time frame: Cycle 1 day 4: pre-dose, start of infusion, end of infusion,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion, day 25: predose, during infusion, end of infusion,30min,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion.
Outcome measures
| Measure |
LY 340 μg/mL + Sunitinib 50 mg
n=13 Participants
LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing.
|
LY 300 μg/mL + Sunitinib 50/37.5 mg
LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks .
|
LY 320 μg/mL + Sunitinib 37.5 mg
LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 340 μg/mL + Sunitinib 37.5 mg
LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 360 μg/mL + Sunitinib 37.5 mg
LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
|---|---|---|---|---|---|
|
Sunitinib Pharmacokinetics in the Presence of LY573636: Area Under the Curve (AUC)
|
780.0 hour*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 51.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 to 42 in Cycles 1 and Cycle 2 (6 weeks per cycle)Population: Participants who received study drug and had sufficient pharmacokinetic (PK) data to calculate AUCalb at the specified time points.
LY573636 has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636. Time frame: Cycle 1:day 4: pre-dose, start of infusion, end of infusion,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion, day 25: predose, during infusion, end of infusion,30min,30min,1h,2h,4h,6h,8h,10h,22h,46h,70h,166h,360h post infusion. Cycle 2: predose and end of infusion.
Outcome measures
| Measure |
LY 340 μg/mL + Sunitinib 50 mg
n=21 Participants
LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing.
|
LY 300 μg/mL + Sunitinib 50/37.5 mg
LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks .
|
LY 320 μg/mL + Sunitinib 37.5 mg
LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 340 μg/mL + Sunitinib 37.5 mg
LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 360 μg/mL + Sunitinib 37.5 mg
LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Curve of LY573636 Above the Albumin Corrected Threshold (AUCalb)
Cycle 1
|
241.3 hour*micrograms per milliliter (h*µg/mL)
Geometric Coefficient of Variation 96.4
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Area Under the Curve of LY573636 Above the Albumin Corrected Threshold (AUCalb)
Cycle 2
|
866.3 hour*micrograms per milliliter (h*µg/mL)
Geometric Coefficient of Variation 437.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to study completion up to 70 weeksPopulation: All participants who received at least one dose of study drug.
Clinically significant effects were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Events module.
Outcome measures
| Measure |
LY 340 μg/mL + Sunitinib 50 mg
n=1 Participants
LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing.
|
LY 300 μg/mL + Sunitinib 50/37.5 mg
n=5 Participants
LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks .
|
LY 320 μg/mL + Sunitinib 37.5 mg
n=3 Participants
LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 340 μg/mL + Sunitinib 37.5 mg
n=6 Participants
LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 360 μg/mL + Sunitinib 37.5 mg
n=6 Participants
LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
|---|---|---|---|---|---|
|
The Number of Participants With Clinically Significant Effects
Serious Adverse Events
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
The Number of Participants With Clinically Significant Effects
Other Nonserious Adverse Events
|
1 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
Adverse Events
LY 340 μg/mL + Sunitinib 50 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
LY 300 μg/mL + Sunitinib 50/37.5 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
LY 320 μg/mL + Sunitinib 37.5 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
LY 340 μg/mL + Sunitinib 37.5 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
LY 360 μg/mL + Sunitinib 37.5 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY 340 μg/mL + Sunitinib 50 mg
n=1 participants at risk
LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing.
|
LY 300 μg/mL + Sunitinib 50/37.5 mg
n=5 participants at risk
LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks .
|
LY 320 μg/mL + Sunitinib 37.5 mg
n=3 participants at risk
LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 340 μg/mL + Sunitinib 37.5 mg
n=6 participants at risk
LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 360 μg/mL + Sunitinib 37.5 mg
n=6 participants at risk
LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
1/1 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.00%
0/1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Fatigue
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Pyrexia
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1
|
20.0%
1/5 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
Other adverse events
| Measure |
LY 340 μg/mL + Sunitinib 50 mg
n=1 participants at risk
LY573636 to target a maximum concentration (Cmax) of 340 micrograms per milliliter (μg/mL) (LY 340 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and sunitinib 50 milligrams (mg) orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing.
|
LY 300 μg/mL + Sunitinib 50/37.5 mg
n=5 participants at risk
LY573636 to target a Cmax of 300 μg/mL (LY 300 μg/mL) as a 2-hour infusion on Days 4 and 25 of a 6-week cycle and either sunitinib 50 mg orally, daily for 4 weeks followed by 2 weeks with no sunitinib dosing or sunitinib 37.5 mg daily continuously for 6 weeks .
|
LY 320 μg/mL + Sunitinib 37.5 mg
n=3 participants at risk
LY573636 to target a Cmax of 320 μg/mL (LY 320 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 340 μg/mL + Sunitinib 37.5 mg
n=6 participants at risk
LY573636 to target a Cmax of 340 μg/mL (LY 340 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
LY 360 μg/mL + Sunitinib 37.5 mg
n=6 participants at risk
LY573636 to target a Cmax of 360 μg/mL (LY 360 μg/mL) as a 2-hour infusion on Day 4 of a 6-week cycle and sunitinib 37.5 mg orally, daily continuously for 6 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1
|
40.0%
2/5 • Number of events 2
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1
|
20.0%
1/5 • Number of events 3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
1/1 • Number of events 1
|
40.0%
2/5 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
1/1 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1
|
60.0%
3/5 • Number of events 4
|
66.7%
2/3 • Number of events 3
|
33.3%
2/6 • Number of events 3
|
50.0%
3/6 • Number of events 6
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
1/1 • Number of events 1
|
60.0%
3/5 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 7
|
33.3%
2/6 • Number of events 2
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Eye discharge
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Eye oedema
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Eye swelling
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1
|
40.0%
2/5 • Number of events 3
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
Cheilitis
|
100.0%
1/1 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1
|
40.0%
2/5 • Number of events 3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Number of events 1
|
80.0%
4/5 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
66.7%
4/6 • Number of events 6
|
83.3%
5/6 • Number of events 5
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Faecal incontinence
|
100.0%
1/1 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1
|
60.0%
3/5 • Number of events 4
|
66.7%
2/3 • Number of events 2
|
66.7%
4/6 • Number of events 5
|
66.7%
4/6 • Number of events 4
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1
|
20.0%
1/5 • Number of events 2
|
0.00%
0/3
|
50.0%
3/6 • Number of events 3
|
33.3%
2/6 • Number of events 4
|
|
General disorders
Asthenia
|
100.0%
1/1 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Catheter site pain
|
100.0%
1/1 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Chest discomfort
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Chest pain
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Chills
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1
|
80.0%
4/5 • Number of events 4
|
66.7%
2/3 • Number of events 2
|
83.3%
5/6 • Number of events 6
|
66.7%
4/6 • Number of events 4
|
|
General disorders
Infusion site induration
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Infusion site pain
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 4
|
|
General disorders
Malaise
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
100.0%
1/1 • Number of events 1
|
40.0%
2/5 • Number of events 3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Oedema
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Oedema peripheral
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
50.0%
3/6 • Number of events 4
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Pain
|
100.0%
1/1 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Pyrexia
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Infections and infestations
Ear infection
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Folliculitis
|
0.00%
0/1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Infection
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Oral herpes
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Blood albumin decreased
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
66.7%
2/3 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Blood glucose increased
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 4
|
0.00%
0/6
|
|
Investigations
Transaminases increased
|
0.00%
0/1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Urine colour abnormal
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Weight decreased
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
1/1 • Number of events 1
|
40.0%
2/5 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
100.0%
1/1 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Nodule on extremity
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1
|
20.0%
1/5 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Ageusia
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
83.3%
5/6 • Number of events 5
|
66.7%
4/6 • Number of events 4
|
|
Nervous system disorders
Headache
|
0.00%
0/1
|
40.0%
2/5 • Number of events 2
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Migraine
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1
|
40.0%
2/5 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Tremor
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
100.0%
1/1 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
100.0%
1/1 • Number of events 1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
66.7%
4/6 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
100.0%
1/1 • Number of events 1
|
60.0%
3/5 • Number of events 5
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1
|
40.0%
2/5 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/1
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1
|
20.0%
1/5 • Number of events 2
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
0.00%
0/1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1
|
40.0%
2/5 • Number of events 2
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/1
|
20.0%
1/5 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Spider naevus
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hot flush
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hypertension
|
100.0%
1/1 • Number of events 1
|
0.00%
0/5
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
0.00%
0/1
|
0.00%
0/5
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
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