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NCT01761240 · OUTCOME

Maximum Tolerated Dose (MTD)

Dose Escalation Study MORAb-066 Targeting Tissue Factor (TF)-Expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC · Source last updated 2024-03-29

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

Measure
NUMBER
Unit
mg/kg
Interval / dispersion
Not reported
Time frame
Cycle 1 (Cycle length=28 days)

What was measured

The MTD was defined as the highest dose level at which no more than one out of six participants experienced DLT. DLT was defined using NCI CTCAE Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade.

Analysis population: The DLT evaluable set included all participants who were evaluable for the DLTs in first cycle and had taken at least 1 dose of study drug.

Groups in this outcome

MORAb-066: All Participants

Participants received, MORAb-066 0.1 or 0.3 or 1 or 2 or 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in a 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.

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

Analysis denominator · Participants

GroupSource count
MORAb-066: All Participants27

Reported measurements

Source class 1
Values in mg/kg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MORAb-066: All Participants2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    units
    Participants
description
The MTD was defined as the highest dose level at which no more than one out of six participants experienced DLT. DLT was defined using NCI CTCAE Version 4.03 as any grade 3 or 4 hematemesis, hemoptysis, hematochezia, bright red blood per rectum, epistaxis, gingival bleeding, hemarthrosis, haematuria, uncontrollable menses, or any other bleeding thought to be significant as per assessment of the investigator, regardless of grade.
groups
  1. description
    Participants received, MORAb-066 0.1 or 0.3 or 1 or 2 or 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in a 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
    id
    OG000
    title
    MORAb-066: All Participants
param Type
NUMBER
population Description
The DLT evaluable set included all participants who were evaluable for the DLTs in first cycle and had taken at least 1 dose of study drug.
reporting Status
POSTED
time Frame
Cycle 1 (Cycle length=28 days)
title
Maximum Tolerated Dose (MTD)
type
SECONDARY
unit Of Measure
mg/kg

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

Preserved source evidence · Not medical advice