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NCT02103478 · OUTCOME

Number of Participants With Adverse Events

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 5 years

What was measured

Number of participants with any treatment-emergent adverse event (AE) and any AE graded ≥3 using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Analysis population: The safety population includes all participants in Phase 1 and Phase 2 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).

Phase 2 Dose Confirmation

Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.

Phase 2 Fixed-Dose Combination

Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.

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
Phase 2 Dose Confirmation50
Phase 2 Fixed-Dose Combination30

Reported measurements

Any Adverse Event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 Dose Escalation Cohort 16Not reportedNot reportedNot reportedNot reported
Phase 1 Dose Escalation Cohort 26Not reportedNot reportedNot reportedNot reported
Phase 1 Dose Escalation Cohort 36Not reportedNot reportedNot reportedNot reported
Phase 1 Dose Escalation Cohort 46Not reportedNot reportedNot reportedNot reported
Phase 1 Dose Escalation Cohort 519Not reportedNot reportedNot reportedNot reported
Phase 2 Dose Confirmation50Not reportedNot reportedNot reportedNot reported
Phase 2 Fixed-Dose Combination30Not reportedNot reportedNot reportedNot reported
Any Grade ≥3 Adverse Event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 Dose Escalation Cohort 15Not reportedNot reportedNot reportedNot reported
Phase 1 Dose Escalation Cohort 26Not reportedNot reportedNot reportedNot reported
Phase 1 Dose Escalation Cohort 35Not reportedNot reportedNot reportedNot reported
Phase 1 Dose Escalation Cohort 46Not reportedNot reportedNot reportedNot reported
Phase 1 Dose Escalation Cohort 518Not reportedNot reportedNot reportedNot reported
Phase 2 Dose Confirmation48Not reportedNot reportedNot reportedNot reported
Phase 2 Fixed-Dose Combination28Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        19
      6. group Id
        OG005
        value
        50
      7. group Id
        OG006
        value
        30
    title
    Any Adverse Event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        18
      6. group Id
        OG005
        value
        48
      7. group Id
        OG006
        value
        28
    title
    Any Grade ≥3 Adverse Event
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
    6. group Id
      OG005
      value
      50
    7. group Id
      OG006
      value
      30
    units
    Participants
description
Number of participants with any treatment-emergent adverse event (AE) and any AE graded ≥3 using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
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
  6. description
    Participants were randomized in a 1:1 ratio to receive either oral cedazuridine (100 mg) + decitabine (35 mg) capsules Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received cedazuridine and decitabine capsules Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
    id
    OG005
    title
    Phase 2 Dose Confirmation
  7. description
    Participants were randomized in a 1:1 ratio to receive either the fixed-dose combination (FDC) tablet (100 mg cedazuridine/35 mg decitabine) Dailyx5 in Course 1 followed by IV decitabine (20 mg/m\^2) Dailyx5 in Course 2 (28 days per course) or the converse. In Courses ≥ 3, all participants received the FDC tablet Dailyx5 in 28-day courses until disease progression, unacceptable toxicity, withdrawal of consent or withdrawal from the study.
    id
    OG006
    title
    Phase 2 Fixed-Dose Combination
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety population includes all participants in Phase 1 and Phase 2 who received at least one dose of investigational product.
reporting Status
POSTED
time Frame
Up to 5 years
title
Number of Participants With Adverse Events
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice