Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03345485 · OUTCOME

Number of Participants With Duration of Stable Disease (SD) That Persists for at Least 4 Months in Selected Solid Tumor Cohorts in Sub Studies.

Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors. · Source last updated 2024-10-21

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
From start of treatment, assessed every 2 cycles, until first documented complete CR, PR or SD, up to 6 months. If SD, assessment continued every 2 cycles until CR/PR/death (up to 6 months).

What was measured

Duration of SD, was defined as the number of days between the date of the first dose of treatment and the first date of disease progression or death. SD was regarded as durable if, after observing SD, the first observation of progression disease was at least 84 days after the start of study treatment.

Analysis population: Analysis population includes only those subjects who achieved stable disease (SD). The Duration of SD (was regarded as durable if, after observing SD, the first observation of PD was at least 84 days after the start of study treatment) was based of number of patients with Best Overall Stable Disease Response.

Groups in this outcome

Tinostamustine (EDO-S101) - Sub Study 1 (SS1)

A dose of 60 mg/m2 administered over 60 minutes on D1 and D15 of 4-week cycles

Tinostamustine (EDO-S101) - Sub Study 2 (SS2)

A dose of 80 mg/m2 administered over 80 minutes on D1 and D15 of 4-week cycles.

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

Analysis denominator · Participants

GroupSource count
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)2
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)1

Reported measurements

<84 days
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)0Not reportedNot reportedNot reportedNot reported
≥84 days
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)2Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    <84 days
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    ≥84 days
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Duration of SD, was defined as the number of days between the date of the first dose of treatment and the first date of disease progression or death. SD was regarded as durable if, after observing SD, the first observation of progression disease was at least 84 days after the start of study treatment.
groups
  1. description
    A dose of 60 mg/m2 administered over 60 minutes on D1 and D15 of 4-week cycles
    id
    OG000
    title
    Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
  2. description
    A dose of 80 mg/m2 administered over 80 minutes on D1 and D15 of 4-week cycles.
    id
    OG001
    title
    Tinostamustine (EDO-S101) - Sub Study 2 (SS2)
param Type
COUNT_OF_PARTICIPANTS
population Description
Analysis population includes only those subjects who achieved stable disease (SD). The Duration of SD (was regarded as durable if, after observing SD, the first observation of PD was at least 84 days after the start of study treatment) was based of number of patients with Best Overall Stable Disease Response.
reporting Status
POSTED
time Frame
From start of treatment, assessed every 2 cycles, until first documented complete CR, PR or SD, up to 6 months. If SD, assessment continued every 2 cycles until CR/PR/death (up to 6 months).
title
Number of Participants With Duration of Stable Disease (SD) That Persists for at Least 4 Months in Selected Solid Tumor Cohorts in Sub Studies.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice