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NCT01892371 · OUTCOME

Maximum Tolerated Dose of Quizartinib (Phase I)

Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome · Source last updated 2025-04-06

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

Measure
NUMBER
Unit
Milligrams
Interval / dispersion
Not reported
Time frame
At 28 days

Groups in this outcome

Phase 1 Arm I (Quizartinib, Azacitidine)

Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Quizartinib: Given PO

Phase 1 Arm II (Quizartinib, Cytarabine)

Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cytarabine: Given SC Quizartinib: Given PO

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 1 Arm I (Quizartinib, Azacitidine)5
Phase 1 Arm II (Quizartinib, Cytarabine)1

Reported measurements

Source class 1
Values in Milligrams · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 Arm I (Quizartinib, Azacitidine)60Not reportedNot reportedNot reportedNot reported
Phase 1 Arm II (Quizartinib, Cytarabine)60Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        60
      2. group Id
        OG001
        value
        60
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      1
    units
    Participants
groups
  1. description
    Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Quizartinib: Given PO
    id
    OG000
    title
    Phase 1 Arm I (Quizartinib, Azacitidine)
  2. description
    Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cytarabine: Given SC Quizartinib: Given PO
    id
    OG001
    title
    Phase 1 Arm II (Quizartinib, Cytarabine)
param Type
NUMBER
reporting Status
POSTED
time Frame
At 28 days
title
Maximum Tolerated Dose of Quizartinib (Phase I)
type
PRIMARY
unit Of Measure
Milligrams

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

Preserved source evidence · Not medical advice