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NCT01254890 · OUTCOME

Phase I: Maximum Tolerated Dose (MTD) of Sorafenib Given With Azacitidine

Sorafenib and 5-Azacitidine in Acute Leukemia + Myelodysplastic Syndrome · Source last updated 2016-05-06

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

Measure
NUMBER
Unit
mg/twice daily
Interval / dispersion
Not reported
Time frame
28 day cycle

What was measured

MTD is defined as highest dose level in which 6 patients treated with at most 1 experiencing a dose limiting toxicity (DLT) during 1st cycle. One cycle of therapy is 7 days of azacitidine (AZA) and 28 days of sorafenib. Starting dose of Sorafenib is 200 mg twice a day azacitidine

Groups in this outcome

Azacitidine + Sorafenib

Azacitidine (AZA) 75 mg/m\^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 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
Azacitidine + Sorafenib3

Reported measurements

Source class 1
Values in mg/twice daily · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine + Sorafenib400Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        400
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    units
    Participants
description
MTD is defined as highest dose level in which 6 patients treated with at most 1 experiencing a dose limiting toxicity (DLT) during 1st cycle. One cycle of therapy is 7 days of azacitidine (AZA) and 28 days of sorafenib. Starting dose of Sorafenib is 200 mg twice a day azacitidine
groups
  1. description
    Azacitidine (AZA) 75 mg/m\^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
    id
    OG000
    title
    Azacitidine + Sorafenib
param Type
NUMBER
reporting Status
POSTED
time Frame
28 day cycle
title
Phase I: Maximum Tolerated Dose (MTD) of Sorafenib Given With Azacitidine
type
PRIMARY
unit Of Measure
mg/twice daily

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

Preserved source evidence · Not medical advice