NCT03245151 · OUTCOME
Phase 1: Trough Concentrations (Ctrough) of Everolimus When Administered in Combination With Lenvatinib
Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors · Source last updated 2023-08-30
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Days 1, 2, 15 and 22: Pre-dose (Cycle length=28 days)
What was measured
Trough concentrations of everolimus was quantified using validated liquid LC-MS/MS methods.
Analysis population: Pharmacokinetic analysis set included participants who had at least one measurable postdose plasma concentration with an adequately documented drug administration history. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and 'number analyzed' signifies participants who were evaluable for given timepoints of this outcome measure. Pharmacokinetic data was planned to be analyzed for Phase 1 only.
Groups in this outcome
Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2
Participants with recurrent or refractory solid tumors received lenvatinib 8 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.
Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2
Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) 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 |
|---|
| Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 5 |
|---|
| Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 17 |
|---|
Reported measurements
Cycle 1 Day 1: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 5 |
|---|
| Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 17 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 0.0 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 0.0 | 0.00 | Not reported | Not reported | Not reported |
|---|
Cycle 1 Day 2: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 5 |
|---|
| Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 17 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 2.1 | 1.34 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 2.2 | 1.13 | Not reported | Not reported | Not reported |
|---|
Cycle 1 Day 15: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 5 |
|---|
| Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 15 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 3.2 | 2.42 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 5.1 | 2.98 | Not reported | Not reported | Not reported |
|---|
Cycle 1 Day 22: Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 5 |
|---|
| Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 15 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 2.8 | 1.96 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 4.2 | 2.73 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.0
- value
- 0.0
- group Id
- OG001
- spread
- 0.00
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 17
- units
- Participants
- title
- Cycle 1 Day 1: Pre-dose
- categories
- measurements
- group Id
- OG000
- spread
- 1.34
- value
- 2.1
- group Id
- OG001
- spread
- 1.13
- value
- 2.2
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 17
- units
- Participants
- title
- Cycle 1 Day 2: Pre-dose
- categories
- measurements
- group Id
- OG000
- spread
- 2.42
- value
- 3.2
- group Id
- OG001
- spread
- 2.98
- value
- 5.1
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- Cycle 1 Day 15: Pre-dose
- categories
- measurements
- group Id
- OG000
- spread
- 1.96
- value
- 2.8
- group Id
- OG001
- spread
- 2.73
- value
- 4.2
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- Cycle 1 Day 22: Pre-dose
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 17
- units
- Participants
- description
- Trough concentrations of everolimus was quantified using validated liquid LC-MS/MS methods.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with recurrent or refractory solid tumors received lenvatinib 8 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.
- id
- OG000
- title
- Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2
- description
- Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.
- id
- OG001
- title
- Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2
- param Type
- MEAN
- population Description
- Pharmacokinetic analysis set included participants who had at least one measurable postdose plasma concentration with an adequately documented drug administration history. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and 'number analyzed' signifies participants who were evaluable for given timepoints of this outcome measure. Pharmacokinetic data was planned to be analyzed for Phase 1 only.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Days 1, 2, 15 and 22: Pre-dose (Cycle length=28 days)
- title
- Phase 1: Trough Concentrations (Ctrough) of Everolimus When Administered in Combination With Lenvatinib
- type
- SECONDARY
- unit Of Measure
- ng/mL
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