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NCT01126749 · OUTCOME

Phase 2: Percentage of Participants With Progression-free Survival at Week 12

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Week 12

What was measured

PFS was defined as the time from the date of randomization until the earlier of the following two events: the date of PD or the date of death based on RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.

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. Due to the lack of a clear definition for PFS censoring rules and deviation from the statistical analysis plan relating to interim analyses, the PFS analysis was deemed unreliable and therefore data was not collected and reported.

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^20
Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^20

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
PFS was defined as the time from the date of randomization until the earlier of the following two events: the date of PD or the date of death based on RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.
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
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. Due to the lack of a clear definition for PFS censoring rules and deviation from the statistical analysis plan relating to interim analyses, the PFS analysis was deemed unreliable and therefore data was not collected and reported.
reporting Status
POSTED
time Frame
Week 12
title
Phase 2: Percentage of Participants With Progression-free Survival at Week 12
type
SECONDARY

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

Preserved source evidence · Not medical advice