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NCT00787527 · OUTCOME

Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat

SAHA + CHOP in Untreated T-cell Non-Hodgkin's Lymphoma · Source last updated 2014-09-09

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
21 Days

What was measured

MTD of Vorinostat defined as highest dose level in which 6 patients have been treated with less than 2 instances of DLT. Continual reassessment during each 21-day cycle to assess DLT. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle. The dose of Vorinostat escalated in successive 3+3 cohorts of participants to determine the MTD.

Groups in this outcome

Schedule A - Vorinostat Once Daily

Vorinostat 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) Doxorubicin : 50 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle Cyclophosphamide : 750 mg/m\^2 by vein over 1 hour on Day 1 of 21 day cycle Vincristine : 1.4 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle

Schedule A - Vorinostat Twice Daily

Vorinostat 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) Doxorubicin : 50 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle Cyclophosphamide : 750 mg/m\^2 by vein over 1 hour on Day 1 of 21 day cycle Vincristine : 1.4 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle

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

Analysis denominator · Participants

GroupSource count
Schedule A - Vorinostat Once Daily6
Schedule A - Vorinostat Twice Daily2

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Schedule A - Vorinostat Once Daily1Not reportedNot reportedNot reportedNot reported
Schedule A - Vorinostat Twice Daily2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      2
    units
    Participants
description
MTD of Vorinostat defined as highest dose level in which 6 patients have been treated with less than 2 instances of DLT. Continual reassessment during each 21-day cycle to assess DLT. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle. The dose of Vorinostat escalated in successive 3+3 cohorts of participants to determine the MTD.
groups
  1. description
    Vorinostat 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) Doxorubicin : 50 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle Cyclophosphamide : 750 mg/m\^2 by vein over 1 hour on Day 1 of 21 day cycle Vincristine : 1.4 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle
    id
    OG000
    title
    Schedule A - Vorinostat Once Daily
  2. description
    Vorinostat 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) Doxorubicin : 50 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle Cyclophosphamide : 750 mg/m\^2 by vein over 1 hour on Day 1 of 21 day cycle Vincristine : 1.4 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle
    id
    OG001
    title
    Schedule A - Vorinostat Twice Daily
param Type
NUMBER
reporting Status
POSTED
time Frame
21 Days
title
Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice