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NCT03922100 · OUTCOME

Phase I - Number of Participants With Drug Related First-cycle Dose Limiting Toxicities (DLTs)

Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML · Source last updated 2026-03-18

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
From screening to end of first 28-days cycle (47 months)

What was measured

DLTs were classified according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Analysis population: Participants evaluable for determination of DLT: For each schedule and dose level tested, this population included all participants enrolled in the dose escalation part who received at least 70% of the study drug in the first cycle, unless the reason for non-compliance was drug-related toxicity, and for whom a DLT assessment was available within the DLT window. In case the participant did not fulfill 1 or more of the aforementioned criteria, he/she was to be replaced.

Groups in this outcome

Phase 1, Schedule A: 20 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 20 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.

Phase 1, Schedule A: 40 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 40 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.

Phase 1, Schedule A: 80 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 80 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.

Phase 1, Schedule A: 120 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.

Phase 1, Schedule A: 180 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle

Phase 1, Schedule A: 270 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 270 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle

Phase 1, Schedule A: 300 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 300 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle

Phase 1, Schedule A: 360 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 360 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle

Phase 1, Schedule B: 120 mg

All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 28 consecutive days, in a 28-day cycle

Phase 1, Schedule B: 180 mg

All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.

Phase 1, Schedule B: 250 mg

All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 250 mg administered orally once daily for 28 consecutive days, in a 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
Phase 1, Schedule A: 20 mg3
Phase 1, Schedule A: 40 mg3
Phase 1, Schedule A: 80 mg3
Phase 1, Schedule A: 120 mg3
Phase 1, Schedule A: 180 mg3
Phase 1, Schedule A: 270 mg3
Phase 1, Schedule A: 300 mg6
Phase 1, Schedule A: 360 mg3
Phase 1, Schedule B: 120 mg3
Phase 1, Schedule B: 180 mg6
Phase 1, Schedule B: 250 mg3

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1, Schedule A: 20 mg0Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule A: 40 mg0Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule A: 80 mg0Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule A: 120 mg0Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule A: 180 mg0Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule A: 270 mg0Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule A: 300 mg0Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule A: 360 mg1Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule B: 120 mg0Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule B: 180 mg1Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule B: 250 mg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      6
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      6
    11. group Id
      OG010
      value
      3
    units
    Participants
description
DLTs were classified according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
groups
  1. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 20 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
    id
    OG000
    title
    Phase 1, Schedule A: 20 mg
  2. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 40 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
    id
    OG001
    title
    Phase 1, Schedule A: 40 mg
  3. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 80 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
    id
    OG002
    title
    Phase 1, Schedule A: 80 mg
  4. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
    id
    OG003
    title
    Phase 1, Schedule A: 120 mg
  5. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
    id
    OG004
    title
    Phase 1, Schedule A: 180 mg
  6. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 270 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
    id
    OG005
    title
    Phase 1, Schedule A: 270 mg
  7. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 300 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
    id
    OG006
    title
    Phase 1, Schedule A: 300 mg
  8. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 360 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
    id
    OG007
    title
    Phase 1, Schedule A: 360 mg
  9. description
    All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
    id
    OG008
    title
    Phase 1, Schedule B: 120 mg
  10. description
    All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.
    id
    OG009
    title
    Phase 1, Schedule B: 180 mg
  11. description
    All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 250 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
    id
    OG010
    title
    Phase 1, Schedule B: 250 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants evaluable for determination of DLT: For each schedule and dose level tested, this population included all participants enrolled in the dose escalation part who received at least 70% of the study drug in the first cycle, unless the reason for non-compliance was drug-related toxicity, and for whom a DLT assessment was available within the DLT window. In case the participant did not fulfill 1 or more of the aforementioned criteria, he/she was to be replaced.
reporting Status
POSTED
time Frame
From screening to end of first 28-days cycle (47 months)
title
Phase I - Number of Participants With Drug Related First-cycle Dose Limiting Toxicities (DLTs)
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice