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NCT03323034 · OUTCOME

MTD/RP2D of Pevonedistat in Combination With Irinotecan and Temozolomide

Pevonedistat, Irinotecan, and Temozolomide in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphoma · Source last updated 2024-10-22

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
Up to 28 days

What was measured

The maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) will be the maximum dose at which fewer than one-third of patients experience dose limiting toxicities.

Analysis population: All Part A patients

Groups in this outcome

Treatment (Pevonedistat, Temozolomide, Irinotecan)

Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment (Pevonedistat, Temozolomide, Irinotecan)30

Reported measurements

Source class 1
Values in mg/m^2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pevonedistat, Temozolomide, Irinotecan)35Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        35
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
The maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) will be the maximum dose at which fewer than one-third of patients experience dose limiting toxicities.
groups
  1. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1.
    id
    OG000
    title
    Treatment (Pevonedistat, Temozolomide, Irinotecan)
param Type
NUMBER
population Description
All Part A patients
reporting Status
POSTED
time Frame
Up to 28 days
title
MTD/RP2D of Pevonedistat in Combination With Irinotecan and Temozolomide
type
PRIMARY
unit Of Measure
mg/m^2

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice