TriangleNCT02564900 · OUTCOME
Pharmacokinetic Analysis: Maximum (Peak) Observed Serum Concentration (Cmax) 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/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Post first dose up to Day 147
What was measured
The serum PK parameters Maximum (peak) Observed serum concentration of DS-8201a and its analytes were estimated using standard non-compartmental method.
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 | 59 |
| Dose Expansion: HER2-expressing Breast Cancer | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Cohort 1, 0.8 mg/kg | 22.9 | 3.76 | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 2, 1.6 mg/kg | 36.2 | 4.98 | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 3, 3.2 mg/kg | 78.2 | 16.1 | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 4, 5.4 mg/kg | 127 | 17.2 | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 5, 6.4 mg/kg | 181 | 33.1 | Not reported | Not reported | Not reported |
| Dose Escalation: Cohort 6, 8.0 mg/kg | 221 | 41.0 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg | 126 | 37.7 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg | 170 | 53.6 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg | 133 | 18.3 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg | 155 | 33.2 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg | 113 | 30.0 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg | 116 | 21.1 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Other Solid Tumors | 150 | 30.3 | Not reported | Not reported | Not reported |
| Dose Expansion: HER2-expressing Breast Cancer | 155 | 21.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.76
- value
- 22.9
- group Id
- OG001
- spread
- 4.98
- value
- 36.2
- group Id
- OG002
- spread
- 16.1
- value
- 78.2
- group Id
- OG003
- spread
- 17.2
- value
- 127
- group Id
- OG004
- spread
- 33.1
- value
- 181
- group Id
- OG005
- spread
- 41.0
- value
- 221
- group Id
- OG006
- spread
- 37.7
- value
- 126
- group Id
- OG007
- spread
- 53.6
- value
- 170
- group Id
- OG008
- spread
- 18.3
- value
- 133
- group Id
- OG009
- spread
- 33.2
- value
- 155
- group Id
- OG010
- spread
- 30.0
- value
- 113
- group Id
- OG011
- spread
- 21.1
- value
- 116
- 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 Maximum (peak) Observed serum concentration of DS-8201a and its analytes were estimated using standard non-compartmental method.
- 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 Analysis: Maximum (Peak) Observed Serum Concentration (Cmax) of Serum DS-8201a Following First Dose
- type
- SECONDARY
- unit Of Measure
- ug/mL
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Preserved source evidence · Not medical advice