TriangleNCT03387020 · OUTCOME
Ribociclib AUC (Area Under the Plasma Concentration Versus Time Curve) as Obtained From the Patients Who Received Phase I Defined Treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hr*uM
- Interval / dispersion
- Full Range
- Time frame
- Pre-dose, 1, 2, 4, 8, 24, 32 (day 1 course 1 only), & 48 (day 1 course 1 only) hours after dose on days 1 and 17 of course 1.
What was measured
Ribociclib plasma concentration-time data obtained from patients who received Phase I defined treatment will be modeled using compartmental approaches to estimate the AUC (hr\*μM) for each dose level on days 1 and 17 of course 1. Patients who were enrolled in the Surgical stratum but subsequently received Phase I defined treatment with PK data available will also be included in the analysis population. 5 patients from surgical stratum received dose level 1 treatment.
Analysis population: Patients with blood samples collected for pharmacokinetic studies on days 1 and 17 of course 1 were included. Surgical patients who received Phase I treatment with samples collected were also included in Dose Level 1. There are total 17 patients received dose level 1 treatment and 3 patients received dose level 2 treatment.
Groups in this outcome
Dose Level 1, Day 1 of Course 1
Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 1 of Course 1.
Dose Level 1, Day 17 of Course 1
Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 17 of Course 1.
Dose Level 2, Day 1 of Course 1
Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 1 of Course 1.
Dose Level 2, Day 17 of Course 1
Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 17 of Course 1
| Group | Source count |
|---|---|
| Dose Level 1, Day 1 of Course 1 | 16 |
| Dose Level 1, Day 17 of Course 1 | 15 |
| Dose Level 2, Day 1 of Course 1 | 3 |
| Dose Level 2, Day 17 of Course 1 | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1, Day 1 of Course 1 | 3.96 | Not reported | 2.6 | 11.2 | Not reported |
| Dose Level 1, Day 17 of Course 1 | 10.3 | Not reported | 5.3 | 18.7 | Not reported |
| Dose Level 2, Day 1 of Course 1 | 12.0 | Not reported | 5.4 | 13.4 | Not reported |
| Dose Level 2, Day 17 of Course 1 | 10.15 | Not reported | 9.6 | 10.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.6
- upper Limit
- 11.2
- value
- 3.96
- group Id
- OG001
- lower Limit
- 5.3
- upper Limit
- 18.7
- value
- 10.3
- group Id
- OG002
- lower Limit
- 5.4
- upper Limit
- 13.4
- value
- 12.0
- group Id
- OG003
- lower Limit
- 9.6
- upper Limit
- 10.7
- value
- 10.15
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- units
- Participants
- description
- Ribociclib plasma concentration-time data obtained from patients who received Phase I defined treatment will be modeled using compartmental approaches to estimate the AUC (hr\*μM) for each dose level on days 1 and 17 of course 1. Patients who were enrolled in the Surgical stratum but subsequently received Phase I defined treatment with PK data available will also be included in the analysis population. 5 patients from surgical stratum received dose level 1 treatment.
- dispersion Type
- Full Range
- groups
- description
- Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 1 of Course 1.
- id
- OG000
- title
- Dose Level 1, Day 1 of Course 1
- description
- Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 17 of Course 1.
- id
- OG001
- title
- Dose Level 1, Day 17 of Course 1
- description
- Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 1 of Course 1.
- id
- OG002
- title
- Dose Level 2, Day 1 of Course 1
- description
- Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 17 of Course 1
- id
- OG003
- title
- Dose Level 2, Day 17 of Course 1
- param Type
- MEDIAN
- population Description
- Patients with blood samples collected for pharmacokinetic studies on days 1 and 17 of course 1 were included. Surgical patients who received Phase I treatment with samples collected were also included in Dose Level 1. There are total 17 patients received dose level 1 treatment and 3 patients received dose level 2 treatment.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 1, 2, 4, 8, 24, 32 (day 1 course 1 only), & 48 (day 1 course 1 only) hours after dose on days 1 and 17 of course 1.
- title
- Ribociclib AUC (Area Under the Plasma Concentration Versus Time Curve) as Obtained From the Patients Who Received Phase I Defined Treatment
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- hr*uM
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice