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NCT03345485 · OUTCOME

Clinical Benefit Response Rate in Selected Solid Tumor Cohorts on Phase 2

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 patients
Interval / dispersion
90% Confidence Interval
Time frame
From start treatment and assessed after every 2 cycles until determination of stable disease and follow up for up to 84 days.

What was measured

The Clinical Benefit Response Rate is calculated as the number of patients with Clinical Benefit Response divided by number of patients in the FAS (in the respective cohort). Clinical Benefit Response is defined as patients achieving stable disease with a duration of at least 12 weeks (84 days). Summary subjects analysed were 36.

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) - Phase 2 SCLC

A dose of study treatment at 80 mg/m2 administered over 1 hour in patients with relapsed/refractory small cell lung cancer.

Tinostamustine (EDO-S101) - Phase 2 STS

A dose of study treatment at 80 mg/m2 administered over 1 hour in in patients with relapsed/refractory soft tissue sarcoma.

Tinostamustine (EDO-S101) - Phase 2 TNBC

A dose of study treatment at 80 mg/m2 administered over 1 hour in patients with relapsed/refractory Triple-negative breast cancer.

Tinostamustine (EDO-S101) - Phase 2 OC

A dose of study treatment at 80 mg/m2 administered over 1 hour in patients with relapsed/refractory Ovarian Cancer.

Tinostamustine (EDO-S101) - Phase 2 EC

A dose of study treatment at 80 mg/m2 administered over 1 hour in patients with relapsed/refractory Endometrial Cancer.

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) - Phase 2 SCLC4
Tinostamustine (EDO-S101) - Phase 2 STS10
Tinostamustine (EDO-S101) - Phase 2 TNBC4
Tinostamustine (EDO-S101) - Phase 2 OC12
Tinostamustine (EDO-S101) - Phase 2 EC6

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 SCLC0Not reported052.7Not reported
Tinostamustine (EDO-S101) - Phase 2 STS40.0Not reported15.069.6Not reported
Tinostamustine (EDO-S101) - Phase 2 TNBC50.0Not reported9.890.2Not reported
Tinostamustine (EDO-S101) - Phase 2 OC50.0Not reported24.575.5Not reported
Tinostamustine (EDO-S101) - Phase 2 EC50.0Not reported15.384.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        52.7
        value
        0
      2. group Id
        OG001
        lower Limit
        15.0
        upper Limit
        69.6
        value
        40.0
      3. group Id
        OG002
        lower Limit
        9.8
        upper Limit
        90.2
        value
        50.0
      4. group Id
        OG003
        lower Limit
        24.5
        upper Limit
        75.5
        value
        50.0
      5. group Id
        OG004
        lower Limit
        15.3
        upper Limit
        84.7
        value
        50.0
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      12
    5. group Id
      OG004
      value
      6
    units
    Participants
description
The Clinical Benefit Response Rate is calculated as the number of patients with Clinical Benefit Response divided by number of patients in the FAS (in the respective cohort). Clinical Benefit Response is defined as patients achieving stable disease with a duration of at least 12 weeks (84 days). Summary subjects analysed were 36.
dispersion Type
90% Confidence Interval
groups
  1. description
    A dose of study treatment at 80 mg/m2 administered over 1 hour in patients with relapsed/refractory small cell lung cancer.
    id
    OG000
    title
    Tinostamustine (EDO-S101) - Phase 2 SCLC
  2. description
    A dose of study treatment at 80 mg/m2 administered over 1 hour in in patients with relapsed/refractory soft tissue sarcoma.
    id
    OG001
    title
    Tinostamustine (EDO-S101) - Phase 2 STS
  3. description
    A dose of study treatment at 80 mg/m2 administered over 1 hour in patients with relapsed/refractory Triple-negative breast cancer.
    id
    OG002
    title
    Tinostamustine (EDO-S101) - Phase 2 TNBC
  4. description
    A dose of study treatment at 80 mg/m2 administered over 1 hour in patients with relapsed/refractory Ovarian Cancer.
    id
    OG003
    title
    Tinostamustine (EDO-S101) - Phase 2 OC
  5. description
    A dose of study treatment at 80 mg/m2 administered over 1 hour in patients with relapsed/refractory Endometrial Cancer.
    id
    OG004
    title
    Tinostamustine (EDO-S101) - Phase 2 EC
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 treatment and assessed after every 2 cycles until determination of stable disease and follow up for up to 84 days.
title
Clinical Benefit Response Rate in Selected Solid Tumor Cohorts on Phase 2
type
PRIMARY
unit Of Measure
percentage of patients

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Preserved source evidence · Not medical advice