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NCT01282463 · OUTCOME

Duration of Response

Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma · Source last updated 2019-09-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
First Criteria Met for CR or PR to Measured PD or Death From Any Cause (Up to 40 Months)

What was measured

The duration of response was measured from the time measurement criteria were first met for a CR or PR (whichever was first recorded) until the first date of objectively documented progressive disease (taking as a reference for progressive disease the smallest measurement recorded since randomization) or the date of death, whichever occurred first. Data for participants who did not relapse or die were censored at the day of their last adequate tumor assessment. Duration of response was estimated by the Kaplan-Meier method.

Analysis population: All randomized participants received one dose of study drug and had CR or PR.

Groups in this outcome

Docetaxel

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Docetaxel + Ramucirumab DP

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Docetaxel + Icrucumab

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

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

Analysis denominator · Participants

GroupSource count
Docetaxel4
Docetaxel + Ramucirumab DP11
Docetaxel + Icrucumab6

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Docetaxel4.6Not reported2.65.6Not reported
Docetaxel + Ramucirumab DP4.6Not reported0.77.0Not reported
Docetaxel + IcrucumabNANot reported2.9NAThe median and the upper limit was not estimable due to a small sample size and 2 participants had PD or Death.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.6
        upper Limit
        5.6
        value
        4.6
      2. group Id
        OG001
        lower Limit
        0.7
        upper Limit
        7.0
        value
        4.6
      3. comment
        The median and the upper limit was not estimable due to a small sample size and 2 participants had PD or Death.
        group Id
        OG002
        lower Limit
        2.9
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      6
    units
    Participants
description
The duration of response was measured from the time measurement criteria were first met for a CR or PR (whichever was first recorded) until the first date of objectively documented progressive disease (taking as a reference for progressive disease the smallest measurement recorded since randomization) or the date of death, whichever occurred first. Data for participants who did not relapse or die were censored at the day of their last adequate tumor assessment. Duration of response was estimated by the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
    id
    OG000
    title
    Docetaxel
  2. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
    id
    OG001
    title
    Docetaxel + Ramucirumab DP
  3. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
    id
    OG002
    title
    Docetaxel + Icrucumab
param Type
MEDIAN
population Description
All randomized participants received one dose of study drug and had CR or PR.
reporting Status
POSTED
time Frame
First Criteria Met for CR or PR to Measured PD or Death From Any Cause (Up to 40 Months)
title
Duration of Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice