Trial Outcomes & Findings for A Study of Ramucirumab Combination Therapy in Japanese Participants Who Have Advanced Stomach Cancer (NCT NCT02359058)
NCT ID: NCT02359058
Last Updated: 2018-01-24
Results Overview
Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
First Dose to Study Completion Plus 30-Day Safety Follow-Up (Up To 22 Months)
Results posted on
2018-01-24
Participant Flow
Participants were considered completed if they either completed Cycle 1 of study drug or discontinued study drug due to a dose limiting toxicity (DLT) during Cycle 1.
Participant milestones
| Measure |
Ramucirumab + Capecitabine + Cisplatin
Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m\^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m\^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Cisplatin
Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m\^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m\^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Oxaliplatin
Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m\^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m\^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Ramucirumab Combination Therapy in Japanese Participants Who Have Advanced Stomach Cancer
Baseline characteristics by cohort
| Measure |
Ramucirumab + Capecitabine + Cisplatin
n=6 Participants
Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m\^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m\^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Cisplatin
n=6 Participants
Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m\^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m\^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Oxaliplatin
n=6 Participants
Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m\^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m\^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 10.93 • n=99 Participants
|
60.3 years
STANDARD_DEVIATION 7.06 • n=107 Participants
|
62.7 years
STANDARD_DEVIATION 6.98 • n=206 Participants
|
60.2 years
STANDARD_DEVIATION 8.30 • n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Japan
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: First Dose to Study Completion Plus 30-Day Safety Follow-Up (Up To 22 Months)Population: All enrolled participants who received at least one dose of study drug.
Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Ramucirumab + Capecitabine + Cisplatin
n=6 Participants
Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m\^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m\^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Cisplatin
n=6 Participants
Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m\^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m\^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Oxaliplatin
n=6 Participants
Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m\^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m\^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
|
Total
Ramucirumab + Capecitabine + Cisplatin, Ramucirumab + S-1 + Cisplatin and Ramucirumab + S-1 + Oxaliplatin.
|
|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 43, Day 50, Day 85 and Day 92: End of InfusionPopulation: All enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.
Maximum Serum Concentration (Cmax) of Ramucirumab.
Outcome measures
| Measure |
Ramucirumab + Capecitabine + Cisplatin
n=6 Participants
Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m\^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m\^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Cisplatin
n=6 Participants
Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m\^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m\^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Oxaliplatin
n=6 Participants
Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m\^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m\^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
|
Total
Ramucirumab + Capecitabine + Cisplatin, Ramucirumab + S-1 + Cisplatin and Ramucirumab + S-1 + Oxaliplatin.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab
Day 85
|
NA microgram per milliliter (μg/mL)
Geometric Coefficient of Variation NA
NA = Data reported as individual values when participants analyzed (n) were less than 3. Individual values of Cmax = 149.00 μg/mL, 216.00 μg/mL.
|
272 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 29
|
NA microgram per milliliter (μg/mL)
Geometric Coefficient of Variation NA
NA = Data reported as individual values when participants analyzed (n) were less than 3. Individual value of Cmax = 239.00 μg/mL.
|
—
|
|
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab
Day 92
|
NA microgram per milliliter (μg/mL)
Geometric Coefficient of Variation NA
NA = Data reported as individual values when participants analyzed (n) were less than 3. Individual values of Cmax = 191.00 μg/mL, 250.00 μg/mL.
|
289 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 22
|
NA microgram per milliliter (μg/mL)
Geometric Coefficient of Variation NA
NA = Data reported as individual values when participants analyzed (n) were less than 3. Individual values of Cmax = 227.00 μg/mL, 278.00 μg/mL.
|
—
|
|
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab
Day 1
|
149 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 21
|
139 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 23
|
137 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 20
|
—
|
|
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab
Day 8
|
229 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 24
|
200 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 21
|
211 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 11
|
—
|
|
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab
Day 43
|
205 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 24
|
253 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 11
|
180 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 28
|
—
|
|
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab
Day 50
|
273 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 24
|
249 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 24
|
207 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 12
|
—
|
SECONDARY outcome
Timeframe: Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 92 and Day 106: Pre-DosePopulation: All enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.
Minimum Serum Concentration (Cmin) of Ramucirumab.
Outcome measures
| Measure |
Ramucirumab + Capecitabine + Cisplatin
n=6 Participants
Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m\^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m\^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Cisplatin
n=6 Participants
Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m\^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m\^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Oxaliplatin
n=6 Participants
Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m\^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m\^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
|
Total
Ramucirumab + Capecitabine + Cisplatin, Ramucirumab + S-1 + Cisplatin and Ramucirumab + S-1 + Oxaliplatin.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab
Day 8
|
43.8 μg/mL
Geometric Coefficient of Variation 16
|
51.6 μg/mL
Geometric Coefficient of Variation 28
|
43.2 μg/mL
Geometric Coefficient of Variation 30
|
—
|
|
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab
Day 43
|
60.8 μg/mL
Geometric Coefficient of Variation 27
|
87.6 μg/mL
Geometric Coefficient of Variation 34
|
68.5 μg/mL
Geometric Coefficient of Variation 41
|
—
|
|
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab
Day 50
|
91.7 μg/mL
Geometric Coefficient of Variation 32
|
91.3 μg/mL
Geometric Coefficient of Variation 28
|
86.2 μg/mL
Geometric Coefficient of Variation 17
|
—
|
|
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab
Day 106
|
68.6 μg/mL
Geometric Coefficient of Variation 52
|
118 μg/mL
Geometric Coefficient of Variation 12
|
NA μg/mL
Geometric Coefficient of Variation NA
NA = Data reported as individual values when participants analyzed (n) were less than 3. Individual values of Cmin = 102.25 μg/mL, 107.50 μg/mL.
|
—
|
|
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab
Day 22
|
40.9 μg/mL
Geometric Coefficient of Variation 21
|
63.9 μg/mL
Geometric Coefficient of Variation 33
|
41.8 μg/mL
Geometric Coefficient of Variation 37
|
—
|
|
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab
Day 29
|
84.6 μg/mL
Geometric Coefficient of Variation 24
|
105 μg/mL
Geometric Coefficient of Variation 19
|
81.6 μg/mL
Geometric Coefficient of Variation 28
|
—
|
|
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab
Day 64
|
47.7 μg/mL
Geometric Coefficient of Variation 31
|
85.4 μg/mL
Geometric Coefficient of Variation 34
|
81.5 μg/mL
Geometric Coefficient of Variation 11
|
—
|
|
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab
Day 71
|
71.1 μg/mL
Geometric Coefficient of Variation 34
|
109 μg/mL
Geometric Coefficient of Variation 13
|
124 μg/mL
Geometric Coefficient of Variation 5
|
—
|
|
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab
Day 85
|
55.5 μg/mL
Geometric Coefficient of Variation 34
|
102 μg/mL
Geometric Coefficient of Variation 18
|
NA μg/mL
Geometric Coefficient of Variation NA
NA = Data reported as individual values when participants analyzed (n) were less than 3. Individual values of Cmin = 94.50 μg/mL, 98.00 μg/mL.
|
—
|
|
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab
Day 92
|
97.6 μg/mL
Geometric Coefficient of Variation 24
|
119 μg/mL
Geometric Coefficient of Variation 14
|
NA μg/mL
Geometric Coefficient of Variation NA
NA = Data reported as individual values when participants analyzed (n) were less than 3. Individual values of Cmin = 66.00 μg/mL, 114.50 μg/mL.
|
—
|
SECONDARY outcome
Timeframe: First Dose to Date of Objective Progressive Disease or Death Due to Any Cause (Up To 22 Months)Population: All enrolled participants who received at least one dose of study drug and with measurable disease.
Objective response rate (ORR) was defined as the percentage of randomized participants achieving a best confirmed overall response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum LD and no progression in non-target lesions.
Outcome measures
| Measure |
Ramucirumab + Capecitabine + Cisplatin
n=5 Participants
Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m\^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m\^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Cisplatin
n=1 Participants
Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m\^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m\^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Oxaliplatin
n=5 Participants
Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m\^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m\^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
|
Total
n=11 Participants
Ramucirumab + Capecitabine + Cisplatin, Ramucirumab + S-1 + Cisplatin and Ramucirumab + S-1 + Oxaliplatin.
|
|---|---|---|---|---|
|
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
|
20 Percentage of participants
|
100 Percentage of participants
|
60 Percentage of participants
|
45.5 Percentage of participants
|
SECONDARY outcome
Timeframe: First dose to study completion plus 30-day safety follow-up (Up To 22 Months)Population: All enrolled participants who received at least one dose of the study drug and had evaluable immunogenicity data.
Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group.
Outcome measures
| Measure |
Ramucirumab + Capecitabine + Cisplatin
n=6 Participants
Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m\^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m\^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Cisplatin
n=6 Participants
Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m\^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m\^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Oxaliplatin
n=6 Participants
Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m\^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m\^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
|
Total
Ramucirumab + Capecitabine + Cisplatin, Ramucirumab + S-1 + Cisplatin and Ramucirumab + S-1 + Oxaliplatin.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Anti-Ramucirumab Antibodies (TE-ADA)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Ramucirumab + Capecitabine + Cisplatin
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Ramucirumab + S-1 + Cisplatin
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Ramucirumab + S-1 + Oxaliplatin
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ramucirumab + Capecitabine + Cisplatin
n=6 participants at risk
Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m\^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m\^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Cisplatin
n=6 participants at risk
Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m\^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m\^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Oxaliplatin
n=6 participants at risk
Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m\^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m\^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
Other adverse events
| Measure |
Ramucirumab + Capecitabine + Cisplatin
n=6 participants at risk
Ramucirumab 8 mg/kg given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m\^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m\^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Cisplatin
n=6 participants at risk
Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m\^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m\^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met.
|
Ramucirumab + S-1 + Oxaliplatin
n=6 participants at risk
Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m\^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m\^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
2/6 • Number of events 3 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
50.0%
3/6 • Number of events 3 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
1/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
4/6 • Number of events 8 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 20 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 3 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 4 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Gastrointestinal disorders
Ascites
|
33.3%
2/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Gastrointestinal disorders
Constipation
|
100.0%
6/6 • Number of events 6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
83.3%
5/6 • Number of events 12 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
50.0%
3/6 • Number of events 3 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
50.0%
3/6 • Number of events 5 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 4 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
83.3%
5/6 • Number of events 11 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
50.0%
3/6 • Number of events 4 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 4 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
50.0%
3/6 • Number of events 4 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
General disorders
Malaise
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 5 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
General disorders
Oedema
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 3 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Infections and infestations
Gingivitis
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Infections and infestations
Rhinitis
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
83.3%
5/6 • Number of events 15 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 5 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
50.0%
3/6 • Number of events 4 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Investigations
Weight decreased
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Investigations
White blood cell count decreased
|
16.7%
1/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 9 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
3/6 • Number of events 5 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
100.0%
6/6 • Number of events 17 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
50.0%
3/6 • Number of events 5 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
50.0%
3/6 • Number of events 3 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 3 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 3 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 3 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
66.7%
4/6 • Number of events 4 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
50.0%
3/6 • Number of events 5 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
50.0%
3/6 • Number of events 3 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 2 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Vascular disorders
Hypertension
|
50.0%
3/6 • Number of events 3 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
66.7%
4/6 • Number of events 5 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
33.3%
2/6 • Number of events 3 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Vascular disorders
Vascular pain
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
|
Vascular disorders
Vasculitis
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
0.00%
0/6 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
16.7%
1/6 • Number of events 1 • First dose to study completion plus 30-day safety follow-up (Up To 22 Months)
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER