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NCT05038800 · OUTCOME

Percentage of Participants Who Experienced a Dose-Limiting Toxicity (DLT)

A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) (MK-0482-002) · Source last updated 2025-05-21

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

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
80% Confidence Interval
Time frame
Cycle 1 (up to 21 days)

What was measured

DLTs were defined as any of the following assessed as treatment-related by investigator (with pre-specified exceptions): Grade (Gr) 4 non-hematologic toxicity; Gr 3 non-hematologic toxicity; Gr 3 or Gr 4 non-hematologic laboratory value if: clinically significant medical intervention was required to treat the participant, the abnormality led to hospitalization, the abnormality persisted for \>1 week, electrolyte imbalances that lasted \>48 hours despite optimal therapy, or the abnormality resulted in a drug-induced liver injury; Gr 4 neutropenia and/or thrombocytopenia lasting \>14 days; \>2 week-delay in starting Cycle 2 due to treatment-related toxicity; treatment-related toxicity resulting in treatment discontinuation during DLT evaluation period; missing \>25% of MK-0482 dose during DLT evaluation period resulting from treatment-related adverse event (AE); or Gr 5 toxicity. The percentage of participants that experienced a DLT was reported for each arm.

Analysis population: The DLT evaluable population included all allocated participants in Part 1 (dose escalation) who received at least 1 dose of study intervention and met the criteria for DLT evaluability (i.e finished Cycle 1 without a DLT, or experienced a DLT in Cycle 1).

Groups in this outcome

MK-0482 7.5 mg Q3W

Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for up to 35 cycles (approximately 24 months).

MK-0482 25 mg Q3W

Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).

MK-0482 75 mg Q3W

Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).

MK-0482 225 mg Q3W

Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).

MK-0482 750 mg Q3W

Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
MK-0482 7.5 mg Q3W1
MK-0482 25 mg Q3W1
MK-0482 75 mg Q3W5
MK-0482 225 mg Q3W3
MK-0482 750 mg Q3W2

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 80% Confidence Interval
GroupValueSpreadLowerUpperComment
MK-0482 7.5 mg Q3W0.0Not reported0.055.3Not reported
MK-0482 25 mg Q3W0.0Not reported0.055.3Not reported
MK-0482 75 mg Q3W0.0Not reported0.023.5Not reported
MK-0482 225 mg Q3W0.0Not reported0.033.1Not reported
MK-0482 750 mg Q3W0.0Not reported0.041.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        55.3
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        55.3
        value
        0.0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        23.5
        value
        0.0
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        33.1
        value
        0.0
      5. group Id
        OG004
        lower Limit
        0.0
        upper Limit
        41.5
        value
        0.0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      2
    units
    Participants
description
DLTs were defined as any of the following assessed as treatment-related by investigator (with pre-specified exceptions): Grade (Gr) 4 non-hematologic toxicity; Gr 3 non-hematologic toxicity; Gr 3 or Gr 4 non-hematologic laboratory value if: clinically significant medical intervention was required to treat the participant, the abnormality led to hospitalization, the abnormality persisted for \>1 week, electrolyte imbalances that lasted \>48 hours despite optimal therapy, or the abnormality resulted in a drug-induced liver injury; Gr 4 neutropenia and/or thrombocytopenia lasting \>14 days; \>2 week-delay in starting Cycle 2 due to treatment-related toxicity; treatment-related toxicity resulting in treatment discontinuation during DLT evaluation period; missing \>25% of MK-0482 dose during DLT evaluation period resulting from treatment-related adverse event (AE); or Gr 5 toxicity. The percentage of participants that experienced a DLT was reported for each arm.
dispersion Type
80% Confidence Interval
groups
  1. description
    Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for up to 35 cycles (approximately 24 months).
    id
    OG000
    title
    MK-0482 7.5 mg Q3W
  2. description
    Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
    id
    OG001
    title
    MK-0482 25 mg Q3W
  3. description
    Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
    id
    OG002
    title
    MK-0482 75 mg Q3W
  4. description
    Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
    id
    OG003
    title
    MK-0482 225 mg Q3W
  5. description
    Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
    id
    OG004
    title
    MK-0482 750 mg Q3W
param Type
NUMBER
population Description
The DLT evaluable population included all allocated participants in Part 1 (dose escalation) who received at least 1 dose of study intervention and met the criteria for DLT evaluability (i.e finished Cycle 1 without a DLT, or experienced a DLT in Cycle 1).
reporting Status
POSTED
time Frame
Cycle 1 (up to 21 days)
title
Percentage of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
type
PRIMARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice