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NCT01193842 · OUTCOME

Pharmacokinetic Clearance (Phase I)

Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas · Source last updated 2023-11-21

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

Measure
MEAN
Unit
Liter/hour
Interval / dispersion
Standard Deviation
Time frame
24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion

What was measured

Serial plasma samples for pharmacokinetic analysis were collected at 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion. Doxorubicin, etoposide, and vincristine concentrations were determined using a validated liquid chromatography-tandem mass spectrometry method. The clearance was determined by dividing the drug-infusion rate by the steady-state concentrations, which was the average of the three time points.

Analysis population: Phase I participants with evaluable pharmacokinetic data

Groups in this outcome

Phase I: VR-DA-EPOCH, Dose Level 1

Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)

Phase I: VR-DA-EPOCH, Dose Level 2

Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)

Phase I: VR-CHOP, Dose Level 1

Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.

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: VR-DA-EPOCH, Dose Level 16
Phase I: VR-DA-EPOCH, Dose Level 25
Phase I: VR-CHOP, Dose Level 10

Reported measurements

Doxorubicin
Values in Liter/hour · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase I: VR-DA-EPOCH, Dose Level 178.648.0Not reportedNot reportedNot reported
Phase I: VR-DA-EPOCH, Dose Level 276.047.9Not reportedNot reportedNot reported
Etoposide
Values in Liter/hour · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase I: VR-DA-EPOCH, Dose Level 13.01.6Not reportedNot reportedNot reported
Phase I: VR-DA-EPOCH, Dose Level 22.40.7Not reportedNot reportedNot reported
Vincristine
Values in Liter/hour · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase I: VR-DA-EPOCH, Dose Level 122.410.2Not reportedNot reportedNot reported
Phase I: VR-DA-EPOCH, Dose Level 216.88.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        48.0
        value
        78.6
      2. group Id
        OG001
        spread
        47.9
        value
        76.0
    title
    Doxorubicin
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.6
        value
        3.0
      2. group Id
        OG001
        spread
        0.7
        value
        2.4
    title
    Etoposide
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.2
        value
        22.4
      2. group Id
        OG001
        spread
        8.9
        value
        16.8
    title
    Vincristine
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      0
    units
    Participants
description
Serial plasma samples for pharmacokinetic analysis were collected at 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion. Doxorubicin, etoposide, and vincristine concentrations were determined using a validated liquid chromatography-tandem mass spectrometry method. The clearance was determined by dividing the drug-infusion rate by the steady-state concentrations, which was the average of the three time points.
dispersion Type
Standard Deviation
groups
  1. description
    Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
    id
    OG000
    title
    Phase I: VR-DA-EPOCH, Dose Level 1
  2. description
    Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
    id
    OG001
    title
    Phase I: VR-DA-EPOCH, Dose Level 2
  3. description
    Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
    id
    OG002
    title
    Phase I: VR-CHOP, Dose Level 1
param Type
MEAN
population Description
Phase I participants with evaluable pharmacokinetic data
reporting Status
POSTED
time Frame
24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion
title
Pharmacokinetic Clearance (Phase I)
type
SECONDARY
unit Of Measure
Liter/hour

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

Preserved source evidence · Not medical advice