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NCT03245151 · OUTCOME

Phase 1: Maximum Tolerated Dose (MTD) 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
milligram per square meter (mg/m^2)
Interval / dispersion
Not reported
Time frame
Cycle 1 (Each cycle was of 28 days)

What was measured

MTD was defined as the highest dose level at which no more than 1/6 participants experienced a dose limiting toxicity (DLTs), with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. DLT was graded according to common terminology criteria for adverse events (CTCAE) version 4.03.

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 milligram per square meter (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
MTD was defined as the highest dose level at which no more than 1/6 participants experienced a dose limiting toxicity (DLTs), with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. DLT was graded according to common terminology criteria for adverse events (CTCAE) version 4.03.
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: Maximum Tolerated Dose (MTD) of Lenvatinib in Combination With Everolimus
type
PRIMARY
unit Of Measure
milligram per square meter (mg/m^2)

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

Preserved source evidence · Not medical advice