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NCT02859415 · OUTCOME

To Evaluate Gene Expression, Deoxyribonucleic Acid (DNA) Methylation and Micro-ribonucleic Acid (RNA) Profiles in Pre- and Post-treatment Tumor Biopsies

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1

What was measured

Studies on tumor tissue obtained during baseline /previous biopsy (if available), Cycle 1 Day 4(+/- 3 days), and possible treatment evaluation following Course 1.

Analysis population: No data was collected thus this outcome measure was not done.

Groups in this outcome

Phase I Dose Level 1 Mithramycin 60 mcg/kg

Phase I Dose Level 1 Mithramycin 60 mcg/kg Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses..

Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg

Phase I Dose Level -1 Mithramycin 60 mcg/kg followed by Mithramycin 30 mcg/kg Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses.

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 I Dose Level 1 Mithramycin 60 mcg/kg0
Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Studies on tumor tissue obtained during baseline /previous biopsy (if available), Cycle 1 Day 4(+/- 3 days), and possible treatment evaluation following Course 1.
groups
  1. description
    Phase I Dose Level 1 Mithramycin 60 mcg/kg Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses..
    id
    OG000
    title
    Phase I Dose Level 1 Mithramycin 60 mcg/kg
  2. description
    Phase I Dose Level -1 Mithramycin 60 mcg/kg followed by Mithramycin 30 mcg/kg Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses.
    id
    OG001
    title
    Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg
population Description
No data was collected thus this outcome measure was not done.
reporting Status
POSTED
time Frame
baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1
title
To Evaluate Gene Expression, Deoxyribonucleic Acid (DNA) Methylation and Micro-ribonucleic Acid (RNA) Profiles in Pre- and Post-treatment Tumor Biopsies
type
SECONDARY

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

Preserved source evidence · Not medical advice