TriangleNCT02564900 · OUTCOME
Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum DS-8201a Following First Dose
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ug*d/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Post first dose up to Day 147
What was measured
The serum PK parameters of DS-8201a and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods.
Analysis population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Groups in this outcome
Dose Escalation: Cohort 1, 0.8 mg/kg
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 2, 1.6 mg/kg
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 3, 3.2 mg/kg
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 4, 5.4 mg/kg
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 5, 6.4 mg/kg
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Escalation: Cohort 6, 8.0 mg/kg
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-expressing Other Solid Tumors
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Dose Expansion: HER2-expressing Breast Cancer
Japan only: Participants with HER2-expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP2).
| Group | Source count |
|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 3 |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 3 |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 3 |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 6 |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 6 |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 5 |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 48 |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 50 |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 20 |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 19 |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 17 |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 23 |
| Dose Expansion: HER2-expressing Other Solid Tumors | 58 |
| Dose Expansion: HER2-expressing Breast Cancer | 21 |
Reported measurements
AUClast
| Group | Source count |
|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 3 |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 3 |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 3 |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 6 |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 6 |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 5 |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 48 |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 50 |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 20 |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 19 |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 17 |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 23 |
| Dose Expansion: HER2-expressing Other Solid Tumors | 58 |
| Dose Expansion: HER2-expressing Breast Cancer | 21 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 51.7 | 13.1 | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 116 | 58.7 | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 325 | 142 | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 544 | 165 | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 901 | 155 | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 996 | 229 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 559 | 178 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 785 | 228 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 581 | 180 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 693 | 178 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 542 | 163 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 507 | 126 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 631 | 184 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Breast Cancer | 693 | 102 | Not reported | Not reported | Not reported |
AUCinfinity
| Group | Source count |
|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 3 |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 3 |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 3 |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 6 |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 6 |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 5 |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 48 |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 49 |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 19 |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 17 |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 17 |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 22 |
| Dose Expansion: HER2-expressing Other Solid Tumors | 58 |
| Dose Expansion: HER2-expressing Breast Cancer | 21 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 55.0 | 11.9 | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 121 | 58.9 | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 340 | 150 | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 590 | 186 | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 1030 | 209 | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 1100 | 259 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 602 | 203 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 848 | 243 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 589 | 145 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 762 | 205 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 596 | 183 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 563 | 151 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 683 | 209 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Breast Cancer | 753 | 118 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 13.1
- value
- 51.7
- group Id
- OG001
- spread
- 58.7
- value
- 116
- group Id
- OG002
- spread
- 142
- value
- 325
- group Id
- OG003
- spread
- 165
- value
- 544
- group Id
- OG004
- spread
- 155
- value
- 901
- group Id
- OG005
- spread
- 229
- value
- 996
- group Id
- OG006
- spread
- 178
- value
- 559
- group Id
- OG007
- spread
- 228
- value
- 785
- group Id
- OG008
- spread
- 180
- value
- 581
- group Id
- OG009
- spread
- 178
- value
- 693
- group Id
- OG010
- spread
- 163
- value
- 542
- group Id
- OG011
- spread
- 126
- value
- 507
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 48
- group Id
- OG007
- value
- 50
- group Id
- OG008
- value
- 20
- group Id
- OG009
- value
- 19
- group Id
- OG010
- value
- 17
- group Id
- OG011
- value
- 23
- units
- Participants
- title
- AUClast
- categories
- measurements
- group Id
- OG000
- spread
- 11.9
- value
- 55.0
- group Id
- OG001
- spread
- 58.9
- value
- 121
- group Id
- OG002
- spread
- 150
- value
- 340
- group Id
- OG003
- spread
- 186
- value
- 590
- group Id
- OG004
- spread
- 209
- value
- 1030
- group Id
- OG005
- spread
- 259
- value
- 1100
- group Id
- OG006
- spread
- 203
- value
- 602
- group Id
- OG007
- spread
- 243
- value
- 848
- group Id
- OG008
- spread
- 145
- value
- 589
- group Id
- OG009
- spread
- 205
- value
- 762
- group Id
- OG010
- spread
- 183
- value
- 596
- group Id
- OG011
- spread
- 151
- value
- 563
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 48
- group Id
- OG007
- value
- 49
- group Id
- OG008
- value
- 19
- group Id
- OG009
- value
- 17
- group Id
- OG010
- value
- 17
- group Id
- OG011
- value
- 22
- units
- Participants
- title
- AUCinfinity
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 48
- group Id
- OG007
- value
- 50
- group Id
- OG008
- value
- 20
- group Id
- OG009
- value
- 19
- group Id
- OG010
- value
- 17
- group Id
- OG011
- value
- 23
- units
- Participants
- description
- The serum PK parameters of DS-8201a and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG000
- title
- Dose Escalation: Cohort 1, 0.8 mg/kg
- description
- Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG001
- title
- Dose Escalation: Cohort 2, 1.6 mg/kg
- description
- Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG002
- title
- Dose Escalation: Cohort 3, 3.2 mg/kg
- description
- Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG003
- title
- Dose Escalation: Cohort 4, 5.4 mg/kg
- description
- Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG004
- title
- Dose Escalation: Cohort 5, 6.4 mg/kg
- description
- Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG005
- title
- Dose Escalation: Cohort 6, 8.0 mg/kg
- description
- Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG006
- title
- Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
- description
- Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG007
- title
- Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
- description
- Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG008
- title
- Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
- description
- Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG009
- title
- Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
- description
- Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG010
- title
- Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
- description
- Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
- id
- OG011
- title
- Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
- param Type
- MEAN
- population Description
- Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
- reporting Status
- POSTED
- time Frame
- Post first dose up to Day 147
- title
- Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum DS-8201a Following First Dose
- type
- SECONDARY
- unit Of Measure
- ug*d/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice