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NCT03345485 · OUTCOME

Objective Response Rate (ORR) and the Clinical Benefit Rate (CBR) That Persists for at Least Four (4) Months in Selected Solid Tumor Cohorts on 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
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
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

To determine the objective response rate (ORR) and the clinical benefit rate (CBR \[Complete Response (CR), Partial Response (PR) plus durable Stable Disease (SD)\]) in Sub Studies. 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.

Analysis population: All subjects who received at least 1 dose of study treatment were included in the Full Analysis (FA) Population. Efficacy analyses were performed on data from all subjects in the FA Population

Groups in this outcome

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

To determine the objective response rate (ORR) (complete response \[CR\] plus partial response \[PR\]) of any duration, plus the rate of subjects with stable disease (SD) of at least 12-week duration at a dose of 60 mg/m2 administered over 1 hour.

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

To determine the objective response rate (ORR) (complete response \[CR\] plus partial response \[PR\]) of any duration, plus the rate of subjects with stable disease (SD) of at least 12-week duration at a dose of 80 mg/m2 administered over 80 minutes.

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)6
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)7

Reported measurements

Objective Response Rate (CR+PR) (%)
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)16.7Not reported0.958.2Not reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)0Not reported034.8Not reported
Clinical Benefit Response Rate (CR+PR+durable SD) %
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)50.0Not reported15.384.7Not reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)14.3Not reported0.752.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        upper Limit
        58.2
        value
        16.7
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        34.8
        value
        0
    title
    Objective Response Rate (CR+PR) (%)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.3
        upper Limit
        84.7
        value
        50.0
      2. group Id
        OG001
        lower Limit
        0.7
        upper Limit
        52.1
        value
        14.3
    title
    Clinical Benefit Response Rate (CR+PR+durable SD) %
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      7
    units
    Participants
description
To determine the objective response rate (ORR) and the clinical benefit rate (CBR \[Complete Response (CR), Partial Response (PR) plus durable Stable Disease (SD)\]) in Sub Studies. 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.
dispersion Type
90% Confidence Interval
groups
  1. description
    To determine the objective response rate (ORR) (complete response \[CR\] plus partial response \[PR\]) of any duration, plus the rate of subjects with stable disease (SD) of at least 12-week duration at a dose of 60 mg/m2 administered over 1 hour.
    id
    OG000
    title
    Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
  2. description
    To determine the objective response rate (ORR) (complete response \[CR\] plus partial response \[PR\]) of any duration, plus the rate of subjects with stable disease (SD) of at least 12-week duration at a dose of 80 mg/m2 administered over 80 minutes.
    id
    OG001
    title
    Tinostamustine (EDO-S101) - Sub Study 2 (SS2)
param Type
NUMBER
population Description
All subjects who received at least 1 dose of study treatment were included in the Full Analysis (FA) Population. Efficacy analyses were performed on data from all subjects in the FA Population
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
Objective Response Rate (ORR) and the Clinical Benefit Rate (CBR) That Persists for at Least Four (4) Months in Selected Solid Tumor Cohorts on Sub Studies
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice