Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02859415 · OUTCOME

Maximum Tolerated Dose (MTD)

Continuous 24h Intravenous Infusion of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in People With Primary Thoracic Malignancies or Carcinomas, Sarcomas or Germ Cell Neoplasms With Pleuropulmonary Metastases · Source last updated 2022-04-05

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

Measure
NUMBER
Unit
mcg/kg
Interval / dispersion
Not reported
Time frame
At the end of first 14 day cycle at each dose level

What was measured

MTD is defined as the number of participants experiencing a dose-limiting toxicity (DLT). A DLT is defined as Grade 4 or greater anemia or neutropenia exceeding 5 days duration, thrombocytopenia requiring transfusion, or Grade 3 or greater nonhematologic toxicity possibly, probably, or definitely related to the investigational therapy excluding alopecia during Cycle 1 of therapy.

Groups in this outcome

All Participants

All participants in phase I dose level 1 and dose level -1.

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

Analysis denominator · Participants

GroupSource count
All Participants3

Reported measurements

Source class 1
Values in mcg/kg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All ParticipantsNANot reportedNot reportedNot reportedThe MTD was not found because we did not have enough participant participation.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The MTD was not found because we did not have enough participant participation.
        group Id
        OG000
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    units
    Participants
description
MTD is defined as the number of participants experiencing a dose-limiting toxicity (DLT). A DLT is defined as Grade 4 or greater anemia or neutropenia exceeding 5 days duration, thrombocytopenia requiring transfusion, or Grade 3 or greater nonhematologic toxicity possibly, probably, or definitely related to the investigational therapy excluding alopecia during Cycle 1 of therapy.
groups
  1. description
    All participants in phase I dose level 1 and dose level -1.
    id
    OG000
    title
    All Participants
param Type
NUMBER
reporting Status
POSTED
time Frame
At the end of first 14 day cycle at each dose level
title
Maximum Tolerated Dose (MTD)
type
PRIMARY
unit Of Measure
mcg/kg

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

Preserved source evidence · Not medical advice