Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03345485 · OUTCOME

Overall Survival (OS) 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
MEDIAN
Unit
Days
Interval / dispersion
90% Confidence Interval
Time frame
From patient's first dose until first documented progression/start of subsequent anti-cancer therapy/death from any cause, whichever came first, up to 42 months.

What was measured

Overall survival is defined as the number days between the date of the first dose of treatment and the date of death. If no date of death is recorded the Overall Survival time is censored at the Last available visit date. Phase 2: To determine the overall survival (OS) time for subjects with solid tumours. SS1:To determine the overall survival (OS) time for subjects who received 60 mg/m2 of EDO-S101 during a 60-minute Infusion. SS2: To determine the overall survival (OS) time for subjects who received 80 mg/m2 of EDO-S101 during a 80-minute Infusion.

Analysis population: Full Analysis Set (FAS): All patients who received at least 1 dose of trial treatment and had at least 1 post-baseline response evaluation.

Groups in this outcome

Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort

Overall survival (OS) time for patients with small cell lung cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.

Tinostamustine (EDO-S101) - Phase 2 STS Cohort

Overall survival (OS) time for patients with soft tissue sarcoma who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.

Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort

Overall survival (OS) time for patients with triple-negative breast cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.

Tinostamustine (EDO-S101) - Phase 2 OC Cohort

Overall survival (OS) time for patients with ovarian cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.

Tinostamustine (EDO-S101) - Phase 2 EC Cohort

Overall survival (OS) time for patients with endometrial cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.

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

Overall survival (OS) time for patients with solid tumour who received 60 mg/m2 of EDO-S101 administered over 1 hour.

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

Overall survival (OS) time for patients with solid tumour who received 80 mg/m2 of EDO-S101 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) - Phase 2 SCLC Cohort4
Tinostamustine (EDO-S101) - Phase 2 STS Cohort10
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort4
Tinostamustine (EDO-S101) - Phase 2 OC Cohort12
Tinostamustine (EDO-S101) - Phase 2 EC Cohort6
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)6
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)7

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort114.5Not reported85.0NACould not be calculated due to insufficient number of participants with events
Tinostamustine (EDO-S101) - Phase 2 STS Cohort346.5Not reported76.0NACould not be calculated due to insufficient number of participants with events
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort218.5Not reported58.0NACould not be calculated due to insufficient number of participants with events
Tinostamustine (EDO-S101) - Phase 2 OC Cohort261.0Not reported121.0NACould not be calculated due to insufficient number of participants with events
Tinostamustine (EDO-S101) - Phase 2 EC Cohort127.0Not reported33.0NACould not be calculated due to insufficient number of participants with events
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)177.0Not reported62.0NACould not be calculated due to insufficient number of participants with events
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)139.0Not reported23.0NACould not be calculated due to insufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Could not be calculated due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        85.0
        upper Limit
        NA
        value
        114.5
      2. comment
        Could not be calculated due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        76.0
        upper Limit
        NA
        value
        346.5
      3. comment
        Could not be calculated due to insufficient number of participants with events
        group Id
        OG002
        lower Limit
        58.0
        upper Limit
        NA
        value
        218.5
      4. comment
        Could not be calculated due to insufficient number of participants with events
        group Id
        OG003
        lower Limit
        121.0
        upper Limit
        NA
        value
        261.0
      5. comment
        Could not be calculated due to insufficient number of participants with events
        group Id
        OG004
        lower Limit
        33.0
        upper Limit
        NA
        value
        127.0
      6. comment
        Could not be calculated due to insufficient number of participants with events
        group Id
        OG005
        lower Limit
        62.0
        upper Limit
        NA
        value
        177.0
      7. comment
        Could not be calculated due to insufficient number of participants with events
        group Id
        OG006
        lower Limit
        23.0
        upper Limit
        NA
        value
        139.0
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
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      7
    units
    Participants
description
Overall survival is defined as the number days between the date of the first dose of treatment and the date of death. If no date of death is recorded the Overall Survival time is censored at the Last available visit date. Phase 2: To determine the overall survival (OS) time for subjects with solid tumours. SS1:To determine the overall survival (OS) time for subjects who received 60 mg/m2 of EDO-S101 during a 60-minute Infusion. SS2: To determine the overall survival (OS) time for subjects who received 80 mg/m2 of EDO-S101 during a 80-minute Infusion.
dispersion Type
90% Confidence Interval
groups
  1. description
    Overall survival (OS) time for patients with small cell lung cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.
    id
    OG000
    title
    Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort
  2. description
    Overall survival (OS) time for patients with soft tissue sarcoma who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.
    id
    OG001
    title
    Tinostamustine (EDO-S101) - Phase 2 STS Cohort
  3. description
    Overall survival (OS) time for patients with triple-negative breast cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.
    id
    OG002
    title
    Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort
  4. description
    Overall survival (OS) time for patients with ovarian cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.
    id
    OG003
    title
    Tinostamustine (EDO-S101) - Phase 2 OC Cohort
  5. description
    Overall survival (OS) time for patients with endometrial cancer who received 80 mg/m2 of EDO-S101 administered over 1 hour on Day 1 and 15 of each 4-week treatment cycle.
    id
    OG004
    title
    Tinostamustine (EDO-S101) - Phase 2 EC Cohort
  6. description
    Overall survival (OS) time for patients with solid tumour who received 60 mg/m2 of EDO-S101 administered over 1 hour.
    id
    OG005
    title
    Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
  7. description
    Overall survival (OS) time for patients with solid tumour who received 80 mg/m2 of EDO-S101 administered over 80 minutes.
    id
    OG006
    title
    Tinostamustine (EDO-S101) - Sub Study 2 (SS2)
param Type
MEDIAN
population Description
Full Analysis Set (FAS): All patients who received at least 1 dose of trial treatment and had at least 1 post-baseline response evaluation.
reporting Status
POSTED
time Frame
From patient's first dose until first documented progression/start of subsequent anti-cancer therapy/death from any cause, whichever came first, up to 42 months.
title
Overall Survival (OS) Time for Phase 2 and Sub Studies
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice