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NCT03345485 · OUTCOME

Maximum Duration of Response (DoR) Time for Phase 2 and 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
days
Interval / dispersion
Not reported
Time frame
From patient's first overall response of CR or PR, until disease progression/subsequent anti-cancer therapy/death from any cause, up to 24 months.

What was measured

The duration of objective response is measured from the date of the first tumor response assessment with an Investigator's Overall Response of CR or PR (whichever status is recorded first) until the date of progression or death. DoR is presented by subject.

Analysis population: Number of participants is zero in some of the arms as no participants achieved a response of CR or PR.

Groups in this outcome

Tinostamustine (EDO-S101) - Phase 2 STS Cohort

Duration of response for patients with soft tissue sarcoma cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour.

Tinostamustine (EDO-S101) - Phase 2 OC Cohort

Duration of response for patients with ovarian cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour.

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

Duration of response for patients with solid tumour who received 60 mg/m2 of EDO-S101 administered over 1 hour.

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 STS Cohort1
Tinostamustine (EDO-S101) - Phase 2 OC Cohort1
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)1

Reported measurements

Source class 1
Values in days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 STS Cohort51Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 OC Cohort52Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)734Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        52
      3. group Id
        OG002
        value
        734
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      1
    units
    Participants
description
The duration of objective response is measured from the date of the first tumor response assessment with an Investigator's Overall Response of CR or PR (whichever status is recorded first) until the date of progression or death. DoR is presented by subject.
groups
  1. description
    Duration of response for patients with soft tissue sarcoma cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour.
    id
    OG000
    title
    Tinostamustine (EDO-S101) - Phase 2 STS Cohort
  2. description
    Duration of response for patients with ovarian cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour.
    id
    OG001
    title
    Tinostamustine (EDO-S101) - Phase 2 OC Cohort
  3. description
    Duration of response for patients with solid tumour who received 60 mg/m2 of EDO-S101 administered over 1 hour.
    id
    OG002
    title
    Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
param Type
NUMBER
population Description
Number of participants is zero in some of the arms as no participants achieved a response of CR or PR.
reporting Status
POSTED
time Frame
From patient's first overall response of CR or PR, until disease progression/subsequent anti-cancer therapy/death from any cause, up to 24 months.
title
Maximum Duration of Response (DoR) Time for Phase 2 and Sub Studies
type
SECONDARY
unit Of Measure
days

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Preserved source evidence · Not medical advice