TriangleNCT01390818 · OUTCOME
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of SAR245409
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, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
What was measured
Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time (0-24 hours) at which the concentration is at or above the lower limit of quantification. Unit of assessment was hour\*nanogram per milliliter (hr\*ng/mL).
Analysis population: The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
Groups in this outcome
SAR245409 30mg
SAR245409 capsule administered at a single oral dose of 30 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).
SAR245409 50mg
SAR245409 capsule administered at a single oral dose of 50 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).
SAR245409 70mg
SAR245409 capsule administered at a single oral dose of 70 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).
SAR245409 90mg
SAR245409 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).
SAR245409 30mg Twice Daily
SAR245409 capsule administered twice, orally, at a 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).
SAR245409 50mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 50 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: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 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: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 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: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 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: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 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 |
|---|---|
| SAR245409 30mg | 6 |
| SAR245409 50mg | 11 |
| SAR245409 70mg | 36 |
| SAR245409 90mg | 3 |
| SAR245409 30mg Twice Daily | 3 |
| SAR245409 50mg Twice Daily | 4 |
| TNBC: SAR245409 70mg Once Daily | 26 |
| NSCLC: SAR245409 70mg Once Daily | 24 |
| CRC: SAR245409 70mg Once Daily | 18 |
| MEL: SAR245409 70mg Once Daily | 15 |
Reported measurements
Day 1 (n=6, 11, 36, 3, 3, 4, 26, 23, 18, 15)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SAR245409 30mg | 683.6 | Not reported | 248.9 | 1878 | Not reported |
| SAR245409 50mg | 1248 | Not reported | 760.1 | 2050 | Not reported |
| SAR245409 70mg | 1566 | Not reported | 1162 | 2111 | Not reported |
| SAR245409 90mg | 3032 | Not reported | 1425 | 6454 | Not reported |
| SAR245409 30mg Twice Daily | 634.0 | Not reported | 111.8 | 3595 | Not reported |
| SAR245409 50mg Twice Daily | 226.2 | Not reported | 82.99 | 616.7 | Not reported |
| TNBC: SAR245409 70mg Once Daily | 1976 | Not reported | 1449 | 2693 | Not reported |
| NSCLC: SAR245409 70mg Once Daily | 1408 | Not reported | 962.5 | 2059 | Not reported |
| CRC: SAR245409 70mg Once Daily | 1479 | Not reported | 824.6 | 2653 | Not reported |
| MEL: SAR245409 70mg Once Daily | 854.9 | Not reported | 505.0 | 1447 | Not reported |
Day 15 (n=6, 8, 25, 1, 1, 3, 17, 17, 10, 13)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SAR245409 30mg | 861.0 | Not reported | 371.5 | 1995 | Not reported |
| SAR245409 50mg | 1125 | Not reported | 558.3 | 2266 | Not reported |
| SAR245409 70mg | 1334 | Not reported | 895.8 | 1986 | Not reported |
| SAR245409 90mg | NA | Not reported | NA | NA | Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation. |
| SAR245409 30mg Twice Daily | NA | Not reported | NA | NA | Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation. |
| SAR245409 50mg Twice Daily | 537.5 | Not reported | 56.10 | 5150 | Not reported |
| TNBC: SAR245409 70mg Once Daily | 2232 | Not reported | 1512 | 3297 | Not reported |
| NSCLC: SAR245409 70mg Once Daily | 1437 | Not reported | 922.1 | 2239 | Not reported |
| CRC: SAR245409 70mg Once Daily | 1365 | Not reported | 543.4 | 3431 | Not reported |
| MEL: SAR245409 70mg Once Daily | 968.8 | Not reported | 554.8 | 1692 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 248.9
- upper Limit
- 1878
- value
- 683.6
- group Id
- OG001
- lower Limit
- 760.1
- upper Limit
- 2050
- value
- 1248
- group Id
- OG002
- lower Limit
- 1162
- upper Limit
- 2111
- value
- 1566
- group Id
- OG003
- lower Limit
- 1425
- upper Limit
- 6454
- value
- 3032
- group Id
- OG004
- lower Limit
- 111.8
- upper Limit
- 3595
- value
- 634.0
- group Id
- OG005
- lower Limit
- 82.99
- upper Limit
- 616.7
- value
- 226.2
- group Id
- OG006
- lower Limit
- 1449
- upper Limit
- 2693
- value
- 1976
- group Id
- OG007
- lower Limit
- 962.5
- upper Limit
- 2059
- value
- 1408
- group Id
- OG008
- lower Limit
- 824.6
- upper Limit
- 2653
- value
- 1479
- group Id
- OG009
- lower Limit
- 505.0
- upper Limit
- 1447
- value
- 854.9
- title
- Day 1 (n=6, 11, 36, 3, 3, 4, 26, 23, 18, 15)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 371.5
- upper Limit
- 1995
- value
- 861.0
- group Id
- OG001
- lower Limit
- 558.3
- upper Limit
- 2266
- value
- 1125
- group Id
- OG002
- lower Limit
- 895.8
- upper Limit
- 1986
- value
- 1334
- comment
- Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG005
- lower Limit
- 56.10
- upper Limit
- 5150
- value
- 537.5
- group Id
- OG006
- lower Limit
- 1512
- upper Limit
- 3297
- value
- 2232
- group Id
- OG007
- lower Limit
- 922.1
- upper Limit
- 2239
- value
- 1437
- group Id
- OG008
- lower Limit
- 543.4
- upper Limit
- 3431
- value
- 1365
- group Id
- OG009
- lower Limit
- 554.8
- upper Limit
- 1692
- value
- 968.8
- title
- Day 15 (n=6, 8, 25, 1, 1, 3, 17, 17, 10, 13)
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 36
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 26
- group Id
- OG007
- value
- 24
- group Id
- OG008
- value
- 18
- group Id
- OG009
- value
- 15
- units
- Participants
- description
- Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time (0-24 hours) at which the concentration is at or above the lower limit of quantification. Unit of assessment was hour\*nanogram per milliliter (hr\*ng/mL).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- SAR245409 capsule administered at a single oral dose of 30 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
- SAR245409 30mg
- description
- SAR245409 capsule administered at a single oral dose of 50 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
- SAR245409 50mg
- description
- SAR245409 capsule administered at a single oral dose of 70 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
- SAR245409 70mg
- description
- SAR245409 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
- SAR245409 90mg
- description
- SAR245409 capsule administered twice, orally, at a 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
- OG004
- title
- SAR245409 30mg Twice Daily
- description
- SAR245409 capsule administered twice, orally, at a dose of 50 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
- SAR245409 50mg Twice Daily
- description
- SAR245409 capsule administered at a single oral dose of 70 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: SAR245409 70mg Once Daily
- description
- SAR245409 capsule administered at a single oral dose of 70 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: SAR245409 70mg Once Daily
- description
- SAR245409 capsule administered at a single oral dose of 70 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: SAR245409 70mg Once Daily
- description
- SAR245409 capsule administered at a single oral dose of 70 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: SAR245409 70mg Once Daily
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
- reporting Status
- POSTED
- time Frame
- Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
- title
- Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of SAR245409
- type
- SECONDARY
- unit Of Measure
- hr*ng/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice