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NCT00474929 · OUTCOME

Number of Participants Reporting a Dose Limiting Toxicity (DLT)

Sorafenib and Everolimus in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma · Source last updated 2019-08-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
First cycle (28 days) of study treatment

What was measured

The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). Dose-limiting toxicity (DLT) is defined as an adverse event attributed (definitely, probably, or possibly) in first cycle to the study treatment and meeting the following criteria: * Grade 4 infection * Grade 4 ANC or PLT * Grade 3 or higher non-hematologic adverse event. NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 will be used to assess adverse events. For this endpoint, the number of patients reporting a DLT event are tabulated.

Groups in this outcome

Phase I, Dose Level 0

Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day

Phase I, Dose Level 1

Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day

Phase I, Dose Level 2

Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day

Phase I, Dose Level 3

Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day

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 I, Dose Level 06
Phase I, Dose Level 15
Phase I, Dose Level 25
Phase I, Dose Level 35

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I, Dose Level 01Not reportedNot reportedNot reportedNot reported
Phase I, Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase I, Dose Level 21Not reportedNot reportedNot reportedNot reported
Phase I, Dose Level 32Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    estimate Comment
    Dose Level 1 was chosen as the MTD due to PI concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2. For the best interest of the patients, dose level 1 was chosen as the MTD and the dose level for Phase II.
    group Description
    The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients).
    group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Maximum Tolerated Dose (MTD) Level
    param Value
    1
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    estimate Comment
    Dose Level 1 was chosen as the MTD due to PI concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2. For the best interest of the patients, dose level 1 was chosen as the MTD and the dose level for Phase II.
    group Description
    The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients).
    group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Maximum Tolerated Dose (MTD) Level
    param Value
    1
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      5
    units
    Participants
description
The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). Dose-limiting toxicity (DLT) is defined as an adverse event attributed (definitely, probably, or possibly) in first cycle to the study treatment and meeting the following criteria: * Grade 4 infection * Grade 4 ANC or PLT * Grade 3 or higher non-hematologic adverse event. NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 will be used to assess adverse events. For this endpoint, the number of patients reporting a DLT event are tabulated.
groups
  1. description
    Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
    id
    OG000
    title
    Phase I, Dose Level 0
  2. description
    Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
    id
    OG001
    title
    Phase I, Dose Level 1
  3. description
    Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
    id
    OG002
    title
    Phase I, Dose Level 2
  4. description
    Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
    id
    OG003
    title
    Phase I, Dose Level 3
param Type
NUMBER
reporting Status
POSTED
time Frame
First cycle (28 days) of study treatment
title
Number of Participants Reporting a Dose Limiting Toxicity (DLT)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice