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NCT02103478 · OUTCOME

Duration of Complete Response in Phase 1

Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS) · Source last updated 2024-08-27

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

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
Up to 32 Months

What was measured

Duration of response (in number of days) was calculated from the first time the response was observed to time of relapse or last time point in the study.

Analysis population: The efficacy population includes all participants in Phase 1 who received at least one dose of investigational product.

Groups in this outcome

Phase 1 Dose Escalation Cohort 1

Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).

Phase 1 Dose Escalation Cohort 2

Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).

Phase 1 Dose Escalation Cohort 3

Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).

Phase 1 Dose Escalation Cohort 4

Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).

Phase 1 Dose Escalation Cohort 5

Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).

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 Dose Escalation Cohort 17
Phase 1 Dose Escalation Cohort 26
Phase 1 Dose Escalation Cohort 36
Phase 1 Dose Escalation Cohort 46
Phase 1 Dose Escalation Cohort 519

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1 Dose Escalation Cohort 1546.00Not reported546.0546.0Not reported
Phase 1 Dose Escalation Cohort 2364.00Not reported56.0672.0Not reported
Phase 1 Dose Escalation Cohort 3470.00Not reported470.0470.0Not reported
Phase 1 Dose Escalation Cohort 429.00Not reported29.029.0Not reported
Phase 1 Dose Escalation Cohort 5399.0Not reported202.0420.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        546.0
        upper Limit
        546.0
        value
        546.00
      2. group Id
        OG001
        lower Limit
        56.0
        upper Limit
        672.0
        value
        364.00
      3. group Id
        OG002
        lower Limit
        470.0
        upper Limit
        470.0
        value
        470.00
      4. group Id
        OG003
        lower Limit
        29.0
        upper Limit
        29.0
        value
        29.00
      5. group Id
        OG004
        lower Limit
        202.0
        upper Limit
        420.0
        value
        399.0
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      19
    units
    Participants
description
Duration of response (in number of days) was calculated from the first time the response was observed to time of relapse or last time point in the study.
dispersion Type
Full Range
groups
  1. description
    Cohort 1 was administered 40 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
    id
    OG000
    title
    Phase 1 Dose Escalation Cohort 1
  2. description
    Cohort 2 was administered 60 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
    id
    OG001
    title
    Phase 1 Dose Escalation Cohort 2
  3. description
    Cohort 3 was administered 100 mg oral cedazuridine and 20 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
    id
    OG002
    title
    Phase 1 Dose Escalation Cohort 3
  4. description
    Cohort 4 was administered 100 mg oral cedazuridine and 40 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
    id
    OG003
    title
    Phase 1 Dose Escalation Cohort 4
  5. description
    Cohort 5 was administered 100 mg oral cedazuridine and 30 mg oral decitabine. Participants were enrolled into successive cohorts in which either the cedazuridine or decitabine oral dose was varied in Course 1 Day 2 through Course 1 Day 5 for comparison with a single dose of IV decitabine at 20 mg/m\^2 administered on Day 1 by continuous IV infusion over 1 hour (28 days per course).
    id
    OG004
    title
    Phase 1 Dose Escalation Cohort 5
param Type
MEDIAN
population Description
The efficacy population includes all participants in Phase 1 who received at least one dose of investigational product.
reporting Status
POSTED
time Frame
Up to 32 Months
title
Duration of Complete Response in Phase 1
type
SECONDARY
unit Of Measure
days

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Preserved source evidence · Not medical advice