TriangleNCT03387020 · OUTCOME
Everolimus AUC (Area Under the Plasma Concentration Versus Time Curve) as Obtained From the Phase I Study
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hr*nM
- Interval / dispersion
- Full Range
- Time frame
- Pre-dose, 0.5 (course 2 only), 1, 1.5 (course 2 only), 2, 4, 6 (course 2 only), 8, 24 hours after dose on day 17 of course 1, and day 1 of course 2.
What was measured
Everolimus plasma concentration-time data obtained from patients who received Phase I defined treatment will be modeled using compartmental approaches to estimate the AUC (hr\*nM) for each dose level on day 17 of course 1 and day 1 of course 2. 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 day 17 of course 1 and day 1 of course 2 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. Analysis population only includes treated patients with corresponding PK data available.
Groups in this outcome
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 1, Day 1 of Course 2
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 2.
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.
Dose Level 2, Day 1 of Course 2
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 2.
| Group | Source count |
|---|---|
| Dose Level 1, Day 17 of Course 1 | 14 |
| Dose Level 1, Day 1 of Course 2 | 10 |
| Dose Level 2, Day 17 of Course 1 | 2 |
| Dose Level 2, Day 1 of Course 2 | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1, Day 17 of Course 1 | 201 | Not reported | 52.7 | 399 | Not reported |
| Dose Level 1, Day 1 of Course 2 | 80.1 | Not reported | 29.8 | 146 | Not reported |
| Dose Level 2, Day 17 of Course 1 | 147.5 | Not reported | 119 | 176 | Not reported |
| Dose Level 2, Day 1 of Course 2 | 59 | Not reported | 42.5 | 75.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 52.7
- upper Limit
- 399
- value
- 201
- group Id
- OG001
- lower Limit
- 29.8
- upper Limit
- 146
- value
- 80.1
- group Id
- OG002
- lower Limit
- 119
- upper Limit
- 176
- value
- 147.5
- group Id
- OG003
- lower Limit
- 42.5
- upper Limit
- 75.5
- value
- 59
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- units
- Participants
- description
- Everolimus plasma concentration-time data obtained from patients who received Phase I defined treatment will be modeled using compartmental approaches to estimate the AUC (hr\*nM) for each dose level on day 17 of course 1 and day 1 of course 2. 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 17 of Course 1.
- id
- OG000
- 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 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 2.
- id
- OG001
- title
- Dose Level 1, Day 1 of Course 2
- 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
- OG002
- title
- Dose Level 2, 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 2.
- id
- OG003
- title
- Dose Level 2, Day 1 of Course 2
- param Type
- MEDIAN
- population Description
- Patients with blood samples collected for pharmacokinetic studies on day 17 of course 1 and day 1 of course 2 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. Analysis population only includes treated patients with corresponding PK data available.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 0.5 (course 2 only), 1, 1.5 (course 2 only), 2, 4, 6 (course 2 only), 8, 24 hours after dose on day 17 of course 1, and day 1 of course 2.
- title
- Everolimus AUC (Area Under the Plasma Concentration Versus Time Curve) as Obtained From the Phase I Study
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- hr*nM
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Preserved source evidence · Not medical advice