Trial Outcomes & Findings for A Study of LY2603618 in Combination With Gemcitabine in Participants With Solid Tumors (NCT NCT01341457)
NCT ID: NCT01341457
Last Updated: 2019-03-01
Results Overview
DLT is defined as adverse event (AE) during Cycle 1 (Days 1 through 28) that was possibly related to the study drug and toxicities considered by the investigator as dose limiting. A summary of other nonserious AEs, and all serious adverse events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
Cycle 1 (28 Days)
Results posted on
2019-03-01
Participant Flow
Participant study completion is defined as a participant completing the primary and secondary objective assessments.
Participant milestones
| Measure |
170 mg LY2603618 + Gemcitabine
Gemcitabine 1000 milligrams per meter squared (mg/m²) administered intravenously (IV) on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
230 mg LY2603618 + Gemcitabine
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
|
Overall Study
Received at Least One Dose of Study Drug
|
7
|
10
|
|
Overall Study
COMPLETED
|
5
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
170 mg LY2603618 + Gemcitabine
Gemcitabine 1000 milligrams per meter squared (mg/m²) administered intravenously (IV) on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
230 mg LY2603618 + Gemcitabine
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
A Study of LY2603618 in Combination With Gemcitabine in Participants With Solid Tumors
Baseline characteristics by cohort
| Measure |
170 mg LY2603618 + Gemcitabine
n=7 Participants
Gemcitabine 1000 milligrams per meter squared (mg/m²) administered intravenously (IV) on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
230 mg LY2603618 + Gemcitabine
n=10 Participants
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 9.33 • n=93 Participants
|
60.8 years
STANDARD_DEVIATION 6.81 • n=4 Participants
|
61.3 years
STANDARD_DEVIATION 7.69 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Japan
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28 Days)Population: Participants who completed the first cycle of study treatment or who discontinued study treatment due to a DLT. There was one participant in the 170 mg LY2603618 treatment group that had an insufficient number of doses of gemcitabine to evaluate DLT.
DLT is defined as adverse event (AE) during Cycle 1 (Days 1 through 28) that was possibly related to the study drug and toxicities considered by the investigator as dose limiting. A summary of other nonserious AEs, and all serious adverse events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
170 mg LY2603618 + Gemcitabine
n=6 Participants
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
230 mg LY2603618 + Gemcitabine
n=10 Participants
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
|---|---|---|
|
Number of Participants With Dose Limiting Toxicity (DLT)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 (days 2 and 16) & 2 (day 2): Predose, End of Infusion, 1 hour (h), 3h, 6h, 24h (days 3 and 17), 48h (days 4 and 18 cycle 1 only), 72h (days 5 and 19)Population: All randomized participants who received at least one dose of study drug and have had PK samples collected.
Outcome measures
| Measure |
170 mg LY2603618 + Gemcitabine
n=7 Participants
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
230 mg LY2603618 + Gemcitabine
n=10 Participants
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618
Cycle 1 Day 2
|
3610 Nanograms per Milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
3920 Nanograms per Milliliter (ng/mL)
Geometric Coefficient of Variation 56
|
|
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618
Cycle 1 Day 16
|
3510 Nanograms per Milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
4120 Nanograms per Milliliter (ng/mL)
Geometric Coefficient of Variation 42
|
|
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618
Cycle 2 Day 2
|
3290 Nanograms per Milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
3570 Nanograms per Milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease (Up to 52 Months)Population: All randomized participants who received at least one dose of study drug and had measurable lesion(s).
Participants achieved disease control if they had a best overall response of PR, CR or SD according to RECIST v1.1 (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD); PR at least 30% decrease and PD at least 20% increase in the sum of diameter of target lesions; CR: disappearance of all target lesions). Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. Best response of SD is defined as disease that does not meet the criteria for CR, PR or PD and has been evaluated at least 6 weeks after the first gemcitabine administration.
Outcome measures
| Measure |
170 mg LY2603618 + Gemcitabine
n=7 Participants
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
230 mg LY2603618 + Gemcitabine
n=10 Participants
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
|---|---|---|
|
Number of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Best Overall Response)
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Cycle 1 (days 2 and 16) & 2 (day 2): Predose, End of Infusion, 1 hour (h), 3h, 6h, 24h (days 3 and 17), 48h (days 4 and 18 cycle 1 only), 72h (days 5 and 19)Population: All randomized participants who received at least one dose of study drug and have had PK samples collected.
Outcome measures
| Measure |
170 mg LY2603618 + Gemcitabine
n=7 Participants
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
230 mg LY2603618 + Gemcitabine
n=10 Participants
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
|---|---|---|
|
PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2603618
Cycle 1 Day 1
|
43900 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 74
|
37200 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 71
|
|
PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2603618
Cycle 1 Day 16
|
52600 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 91
|
39000 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 40
|
|
PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2603618
Cycle 2 Day 2
|
47800 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 59
|
35800 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 33
|
SECONDARY outcome
Timeframe: Cycle 1 (days 1 and 15) & 2 (day 1): Predose, End of Infusion, 10 minutes (m), 30m, 60m, 120mPopulation: All randomized participants who received at least one dose of study drug and have had PK samples collected.
Outcome measures
| Measure |
170 mg LY2603618 + Gemcitabine
n=17 Participants
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
230 mg LY2603618 + Gemcitabine
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
|---|---|---|
|
PK: Cmax of Gemcitabine
Cycle 1 Day 1
|
23000 ng/mL
Geometric Coefficient of Variation 16
|
—
|
|
PK: Cmax of Gemcitabine
Cycle 1 Day 15
|
24700 ng/mL
Geometric Coefficient of Variation 25
|
—
|
|
PK: Cmax of Gemcitabine
Cycle 2 Day 1
|
18100 ng/mL
Geometric Coefficient of Variation 27
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (days 1 and 15) & 2 (day 1): Predose, End of Infusion, 10 minutes (m), 30m, 60m, 120mPopulation: All randomized participants who received at least one dose of study drug and have had PK samples collected.
Outcome measures
| Measure |
170 mg LY2603618 + Gemcitabine
n=17 Participants
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
230 mg LY2603618 + Gemcitabine
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
|---|---|---|
|
PK: Cmax of Gemcitabine Metabolite Deoxydifluorouridine (dFdU)
Cycle 1 Day 15
|
38600 ng/mL
Geometric Coefficient of Variation 18
|
—
|
|
PK: Cmax of Gemcitabine Metabolite Deoxydifluorouridine (dFdU)
Cycle 2 Day 1
|
38400 ng/mL
Geometric Coefficient of Variation 18
|
—
|
|
PK: Cmax of Gemcitabine Metabolite Deoxydifluorouridine (dFdU)
Cycle 1 Day 1
|
40100 ng/mL
Geometric Coefficient of Variation 15
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (days 1 and 15) & 2 (day 1): Predose, End of Infusion, 10 minutes (m), 30m, 60m, 120mPopulation: All randomized participants who received at least one dose of study drug and have had PK samples collected.
Outcome measures
| Measure |
170 mg LY2603618 + Gemcitabine
n=17 Participants
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
230 mg LY2603618 + Gemcitabine
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
|---|---|---|
|
PK: AUC(0-∞) of Gemcitabine
Cycle 1 Day 1
|
11600 ng*h/mL
Geometric Coefficient of Variation 17
|
—
|
|
PK: AUC(0-∞) of Gemcitabine
Cycle 1 Day 15
|
12300 ng*h/mL
Geometric Coefficient of Variation 32
|
—
|
|
PK: AUC(0-∞) of Gemcitabine
Cycle 2 Day 1
|
9530 ng*h/mL
Geometric Coefficient of Variation 23
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (days 1 and 15) & 2 (day 1): Predose, End of Infusion, 10 minutes (m), 30m, 60m, 120mPopulation: All randomized participants who received at least one dose of study drug and have had PK samples collected.
Outcome measures
| Measure |
170 mg LY2603618 + Gemcitabine
n=17 Participants
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
230 mg LY2603618 + Gemcitabine
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
|---|---|---|
|
PK: AUC(0-∞) of Gemcitabine Metabolite dFdU
Cycle 1 Day 1
|
126000 ng*h/mL
Geometric Coefficient of Variation 28
|
—
|
|
PK: AUC(0-∞) of Gemcitabine Metabolite dFdU
Cycle 1 Day 15
|
136000 ng*h/mL
Geometric Coefficient of Variation 32
|
—
|
|
PK: AUC(0-∞) of Gemcitabine Metabolite dFdU
Cycle 2 Day 1
|
142000 ng*h/mL
Geometric Coefficient of Variation 23
|
—
|
Adverse Events
170 mg LY2603618 + Gemcitabine
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
230 mg LY2603618 + Gemcitabine
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
170 mg LY2603618 + Gemcitabine
n=7 participants at risk
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
230 mg LY2603618 + Gemcitabine
n=10 participants at risk
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal fistula
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
Other adverse events
| Measure |
170 mg LY2603618 + Gemcitabine
n=7 participants at risk
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
230 mg LY2603618 + Gemcitabine
n=10 participants at risk
Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle.
Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.3%
1/7 • Number of events 1
|
40.0%
4/10 • Number of events 10
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Eye disorders
Macular oedema
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7
|
10.0%
1/10 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 1
|
30.0%
3/10 • Number of events 3
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7
|
10.0%
1/10 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
71.4%
5/7 • Number of events 6
|
80.0%
8/10 • Number of events 18
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/7
|
10.0%
1/10 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7
|
10.0%
1/10 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
3/7 • Number of events 3
|
30.0%
3/10 • Number of events 4
|
|
General disorders
Fatigue
|
28.6%
2/7 • Number of events 3
|
60.0%
6/10 • Number of events 9
|
|
General disorders
Influenza like illness
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Injection site reaction
|
0.00%
0/7
|
10.0%
1/10 • Number of events 2
|
|
General disorders
Malaise
|
0.00%
0/7
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Pyrexia
|
28.6%
2/7 • Number of events 5
|
40.0%
4/10 • Number of events 11
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
57.1%
4/7 • Number of events 4
|
40.0%
4/10 • Number of events 5
|
|
Investigations
Amylase increased
|
0.00%
0/7
|
10.0%
1/10 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
2/7 • Number of events 2
|
30.0%
3/10 • Number of events 6
|
|
Investigations
Blood alkaline phosphatase increased
|
28.6%
2/7 • Number of events 3
|
30.0%
3/10 • Number of events 3
|
|
Investigations
Blood bilirubin increased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Investigations
Blood creatinine increased
|
14.3%
1/7 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Blood magnesium decreased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Investigations
Blood magnesium increased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Investigations
C-reactive protein increased
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
14.3%
1/7 • Number of events 1
|
30.0%
3/10 • Number of events 3
|
|
Investigations
Haemoglobin decreased
|
100.0%
7/7 • Number of events 8
|
80.0%
8/10 • Number of events 8
|
|
Investigations
Neutrophil count decreased
|
71.4%
5/7 • Number of events 15
|
90.0%
9/10 • Number of events 85
|
|
Investigations
Platelet count decreased
|
100.0%
7/7 • Number of events 9
|
60.0%
6/10 • Number of events 47
|
|
Investigations
White blood cell count decreased
|
85.7%
6/7 • Number of events 19
|
90.0%
9/10 • Number of events 84
|
|
Investigations
White blood cell count increased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.9%
3/7 • Number of events 6
|
60.0%
6/10 • Number of events 14
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
28.6%
2/7 • Number of events 3
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
1/7 • Number of events 2
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7
|
30.0%
3/10 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
28.6%
2/7 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1
|
20.0%
2/10 • Number of events 5
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
1/7 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7
|
20.0%
2/10 • Number of events 2
|
|
Nervous system disorders
Vagus nerve disorder
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/7
|
20.0%
2/10 • Number of events 2
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/7
|
10.0%
1/10 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7
|
20.0%
2/10 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Purpura
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7
|
20.0%
2/10 • Number of events 2
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Number of events 4
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
14.3%
1/7 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60