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NCT00112723 · OUTCOME

Maximum Tolerated Dose (MTD)

Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma · Source last updated 2016-08-08

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

Measure
NUMBER
Unit
mg/m2
Interval / dispersion
Not reported
Time frame
28 days

What was measured

The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT.

Groups in this outcome

Dose Level 1 (30+30)

PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV

Level 2 (30+50)

PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.

Level 3 (50+50)

PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.

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

Analysis denominator · Participants

GroupSource count
Dose Level 1 (30+30)11
Level 2 (30+50)12
Level 3 (50+50)12

Reported measurements

Source class 1
Values in mg/m2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 (30+30)60Not reportedNot reportedNot reportedNot reported
Level 2 (30+50)80Not reportedNot reportedNot reportedNot reported
Level 3 (50+50)100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        60
      2. group Id
        OG001
        value
        80
      3. group Id
        OG002
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      12
    units
    Participants
description
The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT.
groups
  1. description
    PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I. alvocidib: Given IV
    id
    OG000
    title
    Dose Level 1 (30+30)
  2. description
    PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
    id
    OG001
    title
    Level 2 (30+50)
  3. description
    PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients receive flavopiridol\* as in phase I at the MTD determined in phase I.
    id
    OG002
    title
    Level 3 (50+50)
param Type
NUMBER
reporting Status
POSTED
time Frame
28 days
title
Maximum Tolerated Dose (MTD)
type
PRIMARY
unit Of Measure
mg/m2

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

Preserved source evidence · Not medical advice