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NCT01126749 · OUTCOME

Phase 2: Percentage of Participants With Overall Response

Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer · Source last updated 2022-02-28

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
95% Confidence Interval
Time frame
From the date of randomization until CR or PR (Up to approximately 6 years 3 months)

What was measured

Overall response rate was defined as the percentage of participants with the best confirmed response of complete response (CR) or partial response (PR) based on RECIST v1.1. CR was defined as complete disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline summed longest diameters.

Analysis population: MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations.

Groups in this outcome

Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2

Participants received Eribulin Mesylate 1.0 mg/m\^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.

Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2

Participants received Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^240
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^239

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^252.5Not reported37.068.0Not reported
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^246.2Not reported30.561.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37.0
        upper Limit
        68.0
        value
        52.5
      2. group Id
        OG001
        lower Limit
        30.5
        upper Limit
        61.8
        value
        46.2
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      39
    units
    Participants
description
Overall response rate was defined as the percentage of participants with the best confirmed response of complete response (CR) or partial response (PR) based on RECIST v1.1. CR was defined as complete disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline summed longest diameters.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Eribulin Mesylate 1.0 mg/m\^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
    id
    OG000
    title
    Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
  2. description
    Participants received Gemcitabine 1000 mg/m\^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.
    id
    OG001
    title
    Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2
param Type
NUMBER
population Description
MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations.
reporting Status
POSTED
time Frame
From the date of randomization until CR or PR (Up to approximately 6 years 3 months)
title
Phase 2: Percentage of Participants With Overall Response
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice