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NCT00112723 · OUTCOME

Pharmacokinetics (Area Under the Curve; AUC) of Flavopiridol

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
MEAN
Unit
hr×μM
Interval / dispersion
Standard Deviation
Time frame
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1

What was measured

Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.

Analysis population: total of 71 PK (Pharmacokinetic) profiles comprising 484 plasma concentration were determined for 45 of 46 patients following treatment

Groups in this outcome

All Dose Levels of Alvocidib

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

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

Analysis denominator · Participants

GroupSource count
All Dose Levels of Alvocidib45

Reported measurements

Day 1
Values in hr×μM · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Dose Levels of Alvocidib10.4045.923Not reportedNot reportedNot reported
Day 22
Values in hr×μM · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Dose Levels of Alvocidib11.9495.109Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.923
        value
        10.404
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.109
        value
        11.949
    title
    Day 22
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    units
    Participants
description
Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.
dispersion Type
Standard Deviation
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
    All Dose Levels of Alvocidib
param Type
MEAN
population Description
total of 71 PK (Pharmacokinetic) profiles comprising 484 plasma concentration were determined for 45 of 46 patients following treatment
reporting Status
POSTED
time Frame
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1
title
Pharmacokinetics (Area Under the Curve; AUC) of Flavopiridol
type
SECONDARY
unit Of Measure
hr×μM

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

Preserved source evidence · Not medical advice