NCT02859415 · OUTCOME

Number of Participants Whose Best Response is a Complete Response (CR) or Partial Response (PR)

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: every 8 weeks until at disease progression, approximately 3.5 months

What was measured

Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Analysis population: One participant in the first group only received one dose, thus was not evaluable.

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

Group	Source count
Phase I Dose Level 1 Mithramycin 60 mcg/kg	0
Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg	2

Reported measurements

Complete Response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG001
value
0
title
Complete Response
categories
measurements
group Id
OG001
value
0
title
Partial Response

denoms

counts
group Id
OG000
value
0
group Id
OG001
value
2
units
Participants

description

groups

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
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

param Type

COUNT_OF_PARTICIPANTS

population Description

One participant in the first group only received one dose, thus was not evaluable.

reporting Status

POSTED

time Frame

every 8 weeks until at disease progression, approximately 3.5 months

title

Number of Participants Whose Best Response is a Complete Response (CR) or Partial Response (PR)

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice