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NCT01606878 · OUTCOME

Maximum Tolerated Dose (MTD) of Crizotinib

Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma · Source last updated 2024-01-05

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 21 days

What was measured

The MTD of crizotinib administered with combination chemotherapy based on the incidence of dose-limiting toxicity (DLT) at which fewer than one-third of patients experience DLT, as assessed by NCI CTCAE version 4.0.

Analysis population: Parts A, B and D MTD/RP2D were not assessed. As of Amendment #3, due to the possibility that many of the non-hematologic DLTs observed to date on the study are related to the palatability of the OS rather than due to true toxicity of the investigational agent, Parts A and B were closed and Part C was then opened to determine the MTD/ RP2D. As of Amendment #4, a new microsphere formulation was added for Part D, but there was no MTD/RP2D.

Groups in this outcome

Part C (Crizotinib, Cyclophosphamide, Topotecan Hydrochloride)

Patients receive crizotinib (capsule formulation) PO BID, cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Part C (Crizotinib, Cyclophosphamide, Topotecan Hydrochloride)11

Reported measurements

Source class 1
Values in mg/m^2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C (Crizotinib, Cyclophosphamide, Topotecan Hydrochloride)215Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        215
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
The MTD of crizotinib administered with combination chemotherapy based on the incidence of dose-limiting toxicity (DLT) at which fewer than one-third of patients experience DLT, as assessed by NCI CTCAE version 4.0.
groups
  1. description
    Patients receive crizotinib (capsule formulation) PO BID, cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Part C (Crizotinib, Cyclophosphamide, Topotecan Hydrochloride)
param Type
NUMBER
population Description
Parts A, B and D MTD/RP2D were not assessed. As of Amendment #3, due to the possibility that many of the non-hematologic DLTs observed to date on the study are related to the palatability of the OS rather than due to true toxicity of the investigational agent, Parts A and B were closed and Part C was then opened to determine the MTD/ RP2D. As of Amendment #4, a new microsphere formulation was added for Part D, but there was no MTD/RP2D.
reporting Status
POSTED
time Frame
Up to 21 days
title
Maximum Tolerated Dose (MTD) of Crizotinib
type
PRIMARY
unit Of Measure
mg/m^2

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

Preserved source evidence · Not medical advice