TriangleNCT01390818 · OUTCOME
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of Pimasertib (MSC1936369B) at Day 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- hr*ng/mL
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts
What was measured
Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method. Terminal rate constant (λz).
Analysis population: The PK analysis set. Here "N" signifies the number of subjects evaluable for this outcome measure. Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of AUCinf.
Groups in this outcome
Pimasertib (MSC1936369B) 15mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Pimasertib (MSC1936369B) 30mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Pimasertib (MSC1936369B) 60mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Pimasertib (MSC1936369B) 90mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Pimasertib (MSC1936369B) 45mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Pimasertib (MSC1936369B) 60mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
TNBC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
NSCLC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
CRC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
MEL: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
| Group | Source count |
|---|---|
| Pimasertib (MSC1936369B) 15mg | 6 |
| Pimasertib (MSC1936369B) 30mg | 9 |
| Pimasertib (MSC1936369B) 60mg | 23 |
| Pimasertib (MSC1936369B) 90mg | 13 |
| Pimasertib (MSC1936369B) 45mg Twice Daily | 3 |
| Pimasertib (MSC1936369B) 60mg Twice Daily | 0 |
| TNBC: Pimasertib 60mg Once Daily | 22 |
| NSCLC: Pimasertib 60mg Once Daily | 22 |
| CRC: Pimasertib 60mg Once Daily | 14 |
| MEL: Pimasertib 60mg Once Daily | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pimasertib (MSC1936369B) 15mg | 451.6 | Not reported | 319.8 | 637.8 | Not reported |
| Pimasertib (MSC1936369B) 30mg | 770.9 | Not reported | 599.9 | 990.6 | Not reported |
| Pimasertib (MSC1936369B) 60mg | 1607 | Not reported | 1237 | 2087 | Not reported |
| Pimasertib (MSC1936369B) 90mg | 2202 | Not reported | 1716 | 2826 | Not reported |
| Pimasertib (MSC1936369B) 45mg Twice Daily | 503.1 | Not reported | 153.1 | 1654 | Not reported |
| TNBC: Pimasertib 60mg Once Daily | 1869 | Not reported | 1451 | 2407 | Not reported |
| NSCLC: Pimasertib 60mg Once Daily | 1830 | Not reported | 1518 | 2207 | Not reported |
| CRC: Pimasertib 60mg Once Daily | 1857 | Not reported | 1414 | 2437 | Not reported |
| MEL: Pimasertib 60mg Once Daily | 1113 | Not reported | 858.9 | 1442 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 319.8
- upper Limit
- 637.8
- value
- 451.6
- group Id
- OG001
- lower Limit
- 599.9
- upper Limit
- 990.6
- value
- 770.9
- group Id
- OG002
- lower Limit
- 1237
- upper Limit
- 2087
- value
- 1607
- group Id
- OG003
- lower Limit
- 1716
- upper Limit
- 2826
- value
- 2202
- group Id
- OG004
- lower Limit
- 153.1
- upper Limit
- 1654
- value
- 503.1
- group Id
- OG006
- lower Limit
- 1451
- upper Limit
- 2407
- value
- 1869
- group Id
- OG007
- lower Limit
- 1518
- upper Limit
- 2207
- value
- 1830
- group Id
- OG008
- lower Limit
- 1414
- upper Limit
- 2437
- value
- 1857
- group Id
- OG009
- lower Limit
- 858.9
- upper Limit
- 1442
- value
- 1113
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 22
- group Id
- OG007
- value
- 22
- group Id
- OG008
- value
- 14
- group Id
- OG009
- value
- 13
- units
- Participants
- description
- Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method. Terminal rate constant (λz).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
- id
- OG000
- title
- Pimasertib (MSC1936369B) 15mg
- description
- Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
- id
- OG001
- title
- Pimasertib (MSC1936369B) 30mg
- description
- Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
- id
- OG002
- title
- Pimasertib (MSC1936369B) 60mg
- description
- Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
- id
- OG003
- title
- Pimasertib (MSC1936369B) 90mg
- description
- Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
- id
- OG004
- title
- Pimasertib (MSC1936369B) 45mg Twice Daily
- description
- Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
- id
- OG005
- title
- Pimasertib (MSC1936369B) 60mg Twice Daily
- description
- Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
- id
- OG006
- title
- TNBC: Pimasertib 60mg Once Daily
- description
- Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
- id
- OG007
- title
- NSCLC: Pimasertib 60mg Once Daily
- description
- Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
- id
- OG008
- title
- CRC: Pimasertib 60mg Once Daily
- description
- Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
- id
- OG009
- title
- MEL: Pimasertib 60mg Once Daily
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK analysis set. Here "N" signifies the number of subjects evaluable for this outcome measure. Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of AUCinf.
- reporting Status
- POSTED
- time Frame
- Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts
- title
- Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of Pimasertib (MSC1936369B) at Day 1
- type
- SECONDARY
- unit Of Measure
- hr*ng/mL
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Preserved source evidence · Not medical advice