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NCT03245151 · OUTCOME

Phase 1: Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Everolimus

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
NUMBER
Unit
mg/m^2
Interval / dispersion
Not reported
Time frame
Cycle 1 (Each cycle was of 28 days)

What was measured

The RP2D of lenvatinib in combination with everolimus was determined by Dose Escalation Committee (DEC) based on safety (including DLTs), pharmacokinetic and clinical data. DLT was graded according to CTCAE v4.03.

Analysis population: SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus).

Groups in this outcome

Phase 1: Lenvatinib + Everolimus (All Participants)

Participants with recurrent or refractory solid tumors received lenvatinib 8 or 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

GroupSource count
Phase 1: Lenvatinib + Everolimus (All Participants)23

Reported measurements

Source class 1
Values in mg/m^2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Lenvatinib + Everolimus (All Participants)11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    units
    Participants
description
The RP2D of lenvatinib in combination with everolimus was determined by Dose Escalation Committee (DEC) based on safety (including DLTs), pharmacokinetic and clinical data. DLT was graded according to CTCAE v4.03.
groups
  1. description
    Participants with recurrent or refractory solid tumors received lenvatinib 8 or 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
    OG000
    title
    Phase 1: Lenvatinib + Everolimus (All Participants)
param Type
NUMBER
population Description
SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus).
reporting Status
POSTED
time Frame
Cycle 1 (Each cycle was of 28 days)
title
Phase 1: Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Everolimus
type
PRIMARY
unit Of Measure
mg/m^2

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice