NCT02443324 · OUTCOME
Phase 1a and 1b: Pharmacokinetics (PK): Minimum Trough Concentration (Cmin) of Ramucirumab
A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer · Source last updated 2024-07-31
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- micrograms/milliliter (μg/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Phase 1a (Gastric-GEJ or BTC participants (pts)): Week (Wk) 1, 3, 6 and 9; Phase 1a (Gastric, NSCLC, or urothelial pts): Wk 3, 6, 9 and 12; Cohort A, A1, A2: Wk 1, 3, 6, 9, 12, 18, 19 and 24; Cohort B,C,D,E: Wk 3, 6, 9, 12, 18, 19 and 24
What was measured
PK: Cmin of Ramucirumab following administration every 3 weeks.
Analysis population: All enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data. PK was assessed both in Phase 1a and 1b as per protocol analysis.
Groups in this outcome
Phase 1a: Gastric-GEJ or BTC
Participants received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Phase 1 a: Gastric, NSCLC, or Urothelial Patients
Participants received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Cohort A
Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Cohort A1
Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Cohort A2
Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Cohort B
Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Cohort C
Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Cohort D
Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Cohort E
Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1a: Gastric-GEJ or BTC | 6 |
|---|
| Phase 1 a: Gastric, NSCLC, or Urothelial Patients | 3 |
|---|
| Cohort A | 16 |
|---|
| Cohort A1 | 22 |
|---|
| Cohort A2 | 26 |
|---|
| Cohort B | 15 |
|---|
| Cohort C | 23 |
|---|
| Cohort D | 15 |
|---|
| Cohort E | 21 |
|---|
Reported measurements
Week 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1a: Gastric-GEJ or BTC | 6 |
|---|
| Phase 1 a: Gastric, NSCLC, or Urothelial Patients | 0 |
|---|
| Cohort A | 16 |
|---|
| Cohort A1 | 22 |
|---|
| Cohort A2 | 26 |
|---|
| Cohort B | 0 |
|---|
| Cohort C | 0 |
|---|
| Cohort D | 0 |
|---|
| Cohort E | 0 |
|---|
Values in micrograms/milliliter (μg/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1a: Gastric-GEJ or BTC | 50.9 | 24 | Not reported | Not reported | Not reported |
|---|
| Cohort A | 44.2 | 28 | Not reported | Not reported | Not reported |
|---|
| Cohort A1 | 45.2 | 41 | Not reported | Not reported | Not reported |
|---|
| Cohort A2 | 45.9 | 23 | Not reported | Not reported | Not reported |
|---|
Week 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1a: Gastric-GEJ or BTC | 5 |
|---|
| Phase 1 a: Gastric, NSCLC, or Urothelial Patients | 3 |
|---|
| Cohort A | 11 |
|---|
| Cohort A1 | 20 |
|---|
| Cohort A2 | 22 |
|---|
| Cohort B | 15 |
|---|
| Cohort C | 23 |
|---|
| Cohort D | 15 |
|---|
| Cohort E | 21 |
|---|
Values in micrograms/milliliter (μg/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1a: Gastric-GEJ or BTC | 52 | 29 | Not reported | Not reported | Not reported |
|---|
| Phase 1 a: Gastric, NSCLC, or Urothelial Patients | 20.9 | 35 | Not reported | Not reported | Not reported |
|---|
| Cohort A | 40 | 48 | Not reported | Not reported | Not reported |
|---|
| Cohort A1 | 44.1 | 57 | Not reported | Not reported | Not reported |
|---|
| Cohort A2 | 45.2 | 32 | Not reported | Not reported | Not reported |
|---|
| Cohort B | 13.3 | 93 | Not reported | Not reported | Not reported |
|---|
| Cohort C | 22.5 | 62 | Not reported | Not reported | Not reported |
|---|
| Cohort D | 20.9 | 54 | Not reported | Not reported | Not reported |
|---|
| Cohort E | 15.6 | 70 | Not reported | Not reported | Not reported |
|---|
Week 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1a: Gastric-GEJ or BTC | 5 |
|---|
| Phase 1 a: Gastric, NSCLC, or Urothelial Patients | 2 |
|---|
| Cohort A | 5 |
|---|
| Cohort A1 | 11 |
|---|
| Cohort A2 | 18 |
|---|
| Cohort B | 12 |
|---|
| Cohort C | 15 |
|---|
| Cohort D | 15 |
|---|
| Cohort E | 18 |
|---|
Values in micrograms/milliliter (μg/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1a: Gastric-GEJ or BTC | 69 | 29 | Not reported | Not reported | Not reported |
|---|
| Phase 1 a: Gastric, NSCLC, or Urothelial Patients | NA | NA | Not reported | Not reported | Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 21.2 μg/mL, 30.6 μg/mL |
|---|
| Cohort A | 79.8 | 30 | Not reported | Not reported | Not reported |
|---|
| Cohort A1 | 69.1 | 68 | Not reported | Not reported | Not reported |
|---|
| Cohort A2 | 61 | 38 | Not reported | Not reported | Not reported |
|---|
| Cohort B | 25.7 | 74 | Not reported | Not reported | Not reported |
|---|
| Cohort C | 33.8 | 68 | Not reported | Not reported | Not reported |
|---|
| Cohort D | 23.3 | 102 | Not reported | Not reported | Not reported |
|---|
| Cohort E | 19.3 | 115 | Not reported | Not reported | Not reported |
|---|
Week 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1a: Gastric-GEJ or BTC | 2 |
|---|
| Phase 1 a: Gastric, NSCLC, or Urothelial Patients | 3 |
|---|
| Cohort A | 8 |
|---|
| Cohort A1 | 6 |
|---|
| Cohort A2 | 13 |
|---|
| Cohort B | 9 |
|---|
| Cohort C | 18 |
|---|
| Cohort D | 11 |
|---|
| Cohort E | 15 |
|---|
Values in micrograms/milliliter (μg/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1a: Gastric-GEJ or BTC | NA | NA | Not reported | Not reported | Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 45.6 μg/mL, 72.5 μg/mL |
|---|
| Phase 1 a: Gastric, NSCLC, or Urothelial Patients | 32.7 | 20.6 | Not reported | Not reported | Not reported |
|---|
| Cohort A | 72.8 | 46 | Not reported | Not reported | Not reported |
|---|
| Cohort A1 | 94.3 | 40 | Not reported | Not reported | Not reported |
|---|
| Cohort A2 | 78.8 | 31 | Not reported | Not reported | Not reported |
|---|
| Cohort B | 32.7 | 60 | Not reported | Not reported | Not reported |
|---|
| Cohort C | 40.1 | 63 | Not reported | Not reported | Not reported |
|---|
| Cohort D | 34.8 | 73 | Not reported | Not reported | Not reported |
|---|
| Cohort E | 28.6 | 90 | Not reported | Not reported | Not reported |
|---|
Week 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1a: Gastric-GEJ or BTC | 0 |
|---|
| Phase 1 a: Gastric, NSCLC, or Urothelial Patients | 2 |
|---|
| Cohort A | 5 |
|---|
| Cohort A1 | 2 |
|---|
| Cohort A2 | 10 |
|---|
| Cohort B | 8 |
|---|
| Cohort C | 16 |
|---|
| Cohort D | 8 |
|---|
| Cohort E | 10 |
|---|
Values in micrograms/milliliter (μg/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1 a: Gastric, NSCLC, or Urothelial Patients | NA | NA | Not reported | Not reported | Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 26.9 μg/mL, 38.7 μg/mL |
|---|
| Cohort A | 89.3 | 35 | Not reported | Not reported | Not reported |
|---|
| Cohort A1 | NA | NA | Not reported | Not reported | Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 140 μg/mL, 160 μg/mL |
|---|
| Cohort A2 | 80.2 | 38 | Not reported | Not reported | Not reported |
|---|
| Cohort B | 36.8 | 48 | Not reported | Not reported | Not reported |
|---|
| Cohort C | 47.1 | 45 | Not reported | Not reported | Not reported |
|---|
| Cohort D | 34.9 | 141 | Not reported | Not reported | Not reported |
|---|
| Cohort E | 26.3 | 89 | Not reported | Not reported | Not reported |
|---|
Week 18
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1a: Gastric-GEJ or BTC | 0 |
|---|
| Phase 1 a: Gastric, NSCLC, or Urothelial Patients | 0 |
|---|
| Cohort A | 5 |
|---|
| Cohort A1 | 2 |
|---|
| Cohort A2 | 7 |
|---|
| Cohort B | 4 |
|---|
| Cohort C | 11 |
|---|
| Cohort D | 5 |
|---|
| Cohort E | 9 |
|---|
Values in micrograms/milliliter (μg/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A | 92.4 | 71 | Not reported | Not reported | Not reported |
|---|
| Cohort A1 | NA | NA | Not reported | Not reported | Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 147 μg/mL, 171 μg/mL |
|---|
| Cohort A2 | 87.6 | 48 | Not reported | Not reported | Not reported |
|---|
| Cohort B | 52.7 | 45 | Not reported | Not reported | Not reported |
|---|
| Cohort C | 44.4 | 31 | Not reported | Not reported | Not reported |
|---|
| Cohort D | 52.6 | 36 | Not reported | Not reported | Not reported |
|---|
| Cohort E | 37.1 | 66 | Not reported | Not reported | Not reported |
|---|
Week 19
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1a: Gastric-GEJ or BTC | 0 |
|---|
| Phase 1 a: Gastric, NSCLC, or Urothelial Patients | 0 |
|---|
| Cohort A | 3 |
|---|
| Cohort A1 | 1 |
|---|
| Cohort A2 | 5 |
|---|
| Cohort B | 0 |
|---|
| Cohort C | 0 |
|---|
| Cohort D | 0 |
|---|
| Cohort E | 0 |
|---|
Values in micrograms/milliliter (μg/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A | 149 | 69 | Not reported | Not reported | Not reported |
|---|
| Cohort A1 | NA | NA | Not reported | Not reported | Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =1. Individual value = 215 μg/mL |
|---|
| Cohort A2 | 120 | 34 | Not reported | Not reported | Not reported |
|---|
Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1a: Gastric-GEJ or BTC | 0 |
|---|
| Phase 1 a: Gastric, NSCLC, or Urothelial Patients | 0 |
|---|
| Cohort A | 3 |
|---|
| Cohort A1 | 1 |
|---|
| Cohort A2 | 3 |
|---|
| Cohort B | 4 |
|---|
| Cohort C | 10 |
|---|
| Cohort D | 2 |
|---|
| Cohort E | 7 |
|---|
Values in micrograms/milliliter (μg/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A | 116 | 83 | Not reported | Not reported | Not reported |
|---|
| Cohort A1 | NA | NA | Not reported | Not reported | Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =1. Individual value = 178 μg/mL |
|---|
| Cohort A2 | 95.7 | 27 | Not reported | Not reported | Not reported |
|---|
| Cohort B | 43.6 | 40 | Not reported | Not reported | Not reported |
|---|
| Cohort C | 45 | 29 | Not reported | Not reported | Not reported |
|---|
| Cohort D | NA | NA | Not reported | Not reported | Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 39.5 μg/mL, 88 μg/mL |
|---|
| Cohort E | 42.1 | 87 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 24
- value
- 50.9
- group Id
- OG002
- spread
- 28
- value
- 44.2
- group Id
- OG003
- spread
- 41
- value
- 45.2
- group Id
- OG004
- spread
- 23
- value
- 45.9
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 16
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 26
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- units
- Participants
- title
- Week 1
- categories
- measurements
- group Id
- OG000
- spread
- 29
- value
- 52
- group Id
- OG001
- spread
- 35
- value
- 20.9
- group Id
- OG002
- spread
- 48
- value
- 40
- group Id
- OG003
- spread
- 57
- value
- 44.1
- group Id
- OG004
- spread
- 32
- value
- 45.2
- group Id
- OG005
- spread
- 93
- value
- 13.3
- group Id
- OG006
- spread
- 62
- value
- 22.5
- group Id
- OG007
- spread
- 54
- value
- 20.9
- group Id
- OG008
- spread
- 70
- value
- 15.6
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 20
- group Id
- OG004
- value
- 22
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 23
- group Id
- OG007
- value
- 15
- group Id
- OG008
- value
- 21
- units
- Participants
- title
- Week 3
- categories
- measurements
- group Id
- OG000
- spread
- 29
- value
- 69
- comment
- Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 21.2 μg/mL, 30.6 μg/mL
- group Id
- OG001
- spread
- NA
- value
- NA
- group Id
- OG002
- spread
- 30
- value
- 79.8
- group Id
- OG003
- spread
- 68
- value
- 69.1
- group Id
- OG004
- spread
- 38
- value
- 61
- group Id
- OG005
- spread
- 74
- value
- 25.7
- group Id
- OG006
- spread
- 68
- value
- 33.8
- group Id
- OG007
- spread
- 102
- value
- 23.3
- group Id
- OG008
- spread
- 115
- value
- 19.3
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 18
- group Id
- OG005
- value
- 12
- group Id
- OG006
- value
- 15
- group Id
- OG007
- value
- 15
- group Id
- OG008
- value
- 18
- units
- Participants
- title
- Week 6
- categories
- measurements
- comment
- Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 45.6 μg/mL, 72.5 μg/mL
- group Id
- OG000
- spread
- NA
- value
- NA
- group Id
- OG001
- spread
- 20.6
- value
- 32.7
- group Id
- OG002
- spread
- 46
- value
- 72.8
- group Id
- OG003
- spread
- 40
- value
- 94.3
- group Id
- OG004
- spread
- 31
- value
- 78.8
- group Id
- OG005
- spread
- 60
- value
- 32.7
- group Id
- OG006
- spread
- 63
- value
- 40.1
- group Id
- OG007
- spread
- 73
- value
- 34.8
- group Id
- OG008
- spread
- 90
- value
- 28.6
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 13
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 18
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 15
- units
- Participants
- title
- Week 9
- categories
- measurements
- comment
- Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 26.9 μg/mL, 38.7 μg/mL
- group Id
- OG001
- spread
- NA
- value
- NA
- group Id
- OG002
- spread
- 35
- value
- 89.3
- comment
- Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 140 μg/mL, 160 μg/mL
- group Id
- OG003
- spread
- NA
- value
- NA
- group Id
- OG004
- spread
- 38
- value
- 80.2
- group Id
- OG005
- spread
- 48
- value
- 36.8
- group Id
- OG006
- spread
- 45
- value
- 47.1
- group Id
- OG007
- spread
- 141
- value
- 34.9
- group Id
- OG008
- spread
- 89
- value
- 26.3
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 16
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 10
- units
- Participants
- title
- Week 12
- categories
- measurements
- group Id
- OG002
- spread
- 71
- value
- 92.4
- comment
- Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 147 μg/mL, 171 μg/mL
- group Id
- OG003
- spread
- NA
- value
- NA
- group Id
- OG004
- spread
- 48
- value
- 87.6
- group Id
- OG005
- spread
- 45
- value
- 52.7
- group Id
- OG006
- spread
- 31
- value
- 44.4
- group Id
- OG007
- spread
- 36
- value
- 52.6
- group Id
- OG008
- spread
- 66
- value
- 37.1
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 9
- units
- Participants
- title
- Week 18
- categories
- measurements
- group Id
- OG002
- spread
- 69
- value
- 149
- comment
- Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =1. Individual value = 215 μg/mL
- group Id
- OG003
- spread
- NA
- value
- NA
- group Id
- OG004
- spread
- 34
- value
- 120
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- units
- Participants
- title
- Week 19
- categories
- measurements
- group Id
- OG002
- spread
- 83
- value
- 116
- comment
- Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =1. Individual value = 178 μg/mL
- group Id
- OG003
- spread
- NA
- value
- NA
- group Id
- OG004
- spread
- 27
- value
- 95.7
- group Id
- OG005
- spread
- 40
- value
- 43.6
- group Id
- OG006
- spread
- 29
- value
- 45
- comment
- Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as n =2. Individual values = 39.5 μg/mL, 88 μg/mL
- group Id
- OG007
- spread
- NA
- value
- NA
- group Id
- OG008
- spread
- 87
- value
- 42.1
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 7
- units
- Participants
- title
- Week 24
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 16
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 26
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 23
- group Id
- OG007
- value
- 15
- group Id
- OG008
- value
- 21
- units
- Participants
- description
- PK: Cmin of Ramucirumab following administration every 3 weeks.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
- id
- OG000
- title
- Phase 1a: Gastric-GEJ or BTC
- description
- Participants received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
- id
- OG001
- title
- Phase 1 a: Gastric, NSCLC, or Urothelial Patients
- description
- Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
- id
- OG002
- title
- Cohort A
- description
- Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
- id
- OG003
- title
- Cohort A1
- description
- Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
- id
- OG004
- title
- Cohort A2
- description
- Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
- id
- OG005
- title
- Cohort B
- description
- Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
- id
- OG006
- title
- Cohort C
- description
- Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
- id
- OG007
- title
- Cohort D
- description
- Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
- id
- OG008
- title
- Cohort E
- param Type
- GEOMETRIC_MEAN
- population Description
- All enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data. PK was assessed both in Phase 1a and 1b as per protocol analysis.
- reporting Status
- POSTED
- time Frame
- Phase 1a (Gastric-GEJ or BTC participants (pts)): Week (Wk) 1, 3, 6 and 9; Phase 1a (Gastric, NSCLC, or urothelial pts): Wk 3, 6, 9 and 12; Cohort A, A1, A2: Wk 1, 3, 6, 9, 12, 18, 19 and 24; Cohort B,C,D,E: Wk 3, 6, 9, 12, 18, 19 and 24
- title
- Phase 1a and 1b: Pharmacokinetics (PK): Minimum Trough Concentration (Cmin) of Ramucirumab
- type
- SECONDARY
- unit Of Measure
- micrograms/milliliter (μg/mL)
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