NCT04154189 · OUTCOME
Treatment Arm A: Plasma Concentration of Lenvatinib
A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma · Source last updated 2024-07-22
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- nanograms per milliliter (ng/mL)
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: Pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: Pre-dose (each Cycle length = 21 days)
What was measured
Plasma concentration of lenvatinib in participants from Treatment Arm A (Lenvatinib + Ifosfamide + Etoposide) at different time points were reported. As planned, data for this outcome measure was analyzed for treatment arm A only. Lenvatinib concentration in plasma was quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method.
Analysis population: Population Pharmacokinetic (PK) Analysis Set included those participants who received at least 1 dose of lenvatinib and had documented dose administration history and measurable plasma concentrations of lenvatinib. Here "overall number of participants analyzed, N" signifies participants who were evaluable for this outcome measure. Here "number analyzed, n" signifies participants who were evaluable for this outcome measure at given time points.
Groups in this outcome
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 37 |
|---|
Reported measurements
Cycle 1, Day 1: 0.5-4 hours post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 37 |
|---|
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 147.9 | 194.61 | Not reported | Not reported | Not reported |
|---|
Cycle 1, Day 1: 6-10 hours post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 35 |
|---|
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 217.8 | 99.54 | Not reported | Not reported | Not reported |
|---|
Cycle 1, Day 15: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 36 |
|---|
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 70.7 | 43.48 | Not reported | Not reported | Not reported |
|---|
Cycle 1, Day 15: 0.5-4 hours post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 37 |
|---|
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 222.3 | 203.07 | Not reported | Not reported | Not reported |
|---|
Cycle 1, Day 15: 6-10 hours post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 35 |
|---|
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 310.9 | 106.79 | Not reported | Not reported | Not reported |
|---|
Cycle 2, Day 1: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 37 |
|---|
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 70.2 | 67.95 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 194.61
- value
- 147.9
- title
- Cycle 1, Day 1: 0.5-4 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 99.54
- value
- 217.8
- title
- Cycle 1, Day 1: 6-10 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 43.48
- value
- 70.7
- title
- Cycle 1, Day 15: Pre-dose
- categories
- measurements
- group Id
- OG000
- spread
- 203.07
- value
- 222.3
- title
- Cycle 1, Day 15: 0.5-4 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 106.79
- value
- 310.9
- title
- Cycle 1, Day 15: 6-10 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 67.95
- value
- 70.2
- title
- Cycle 2, Day 1: Pre-dose
- description
- Plasma concentration of lenvatinib in participants from Treatment Arm A (Lenvatinib + Ifosfamide + Etoposide) at different time points were reported. As planned, data for this outcome measure was analyzed for treatment arm A only. Lenvatinib concentration in plasma was quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
- id
- OG000
- title
- Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
- param Type
- MEAN
- population Description
- Population Pharmacokinetic (PK) Analysis Set included those participants who received at least 1 dose of lenvatinib and had documented dose administration history and measurable plasma concentrations of lenvatinib. Here "overall number of participants analyzed, N" signifies participants who were evaluable for this outcome measure. Here "number analyzed, n" signifies participants who were evaluable for this outcome measure at given time points.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: Pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: Pre-dose (each Cycle length = 21 days)
- title
- Treatment Arm A: Plasma Concentration of Lenvatinib
- type
- SECONDARY
- unit Of Measure
- nanograms per milliliter (ng/mL)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
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