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NCT00787527 · OUTCOME

Phase I Maximum Tolerated Dose (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
mg/day
Interval / dispersion
Not reported
Time frame
21 Days

What was measured

MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. 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); and for Phase II Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).

Groups in this outcome

Schedule A - Vorinostat Once or Twice 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 or 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 or Twice Daily8

Reported measurements

Source class 1
Values in mg/day · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Schedule A - Vorinostat Once or Twice Daily300Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        300
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. 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); and for Phase II Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).
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 or 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
    OG000
    title
    Schedule A - Vorinostat Once or Twice Daily
param Type
NUMBER
reporting Status
POSTED
time Frame
21 Days
title
Phase I Maximum Tolerated Dose (MTD) of Vorinostat
type
PRIMARY
unit Of Measure
mg/day

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

Preserved source evidence · Not medical advice