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NCT01282463 · OUTCOME

Percentage of Participants Achieving Objective Response Rate (ORR)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Randomization to Measured PD (Up to 40 Months)

What was measured

Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels \[if tumor markers were initially above the upper limit of normal (ULN)\]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)\*100.

Analysis population: All randomized participants who received one dose of study drug.

Groups in this outcome

Docetaxel

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 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
Docetaxel45
Docetaxel + Ramucirumab DP46
Docetaxel + Icrucumab49

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Docetaxel8.9Not reported2.521.2Not reported
Docetaxel + Ramucirumab DP23.9Not reported12.638.8Not reported
Docetaxel + Icrucumab12.2Not reported4.624.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.5
        upper Limit
        21.2
        value
        8.9
      2. group Id
        OG001
        lower Limit
        12.6
        upper Limit
        38.8
        value
        23.9
      3. group Id
        OG002
        lower Limit
        4.6
        upper Limit
        24.8
        value
        12.2
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    2. group Id
      OG001
      value
      46
    3. group Id
      OG002
      value
      49
    units
    Participants
description
Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels \[if tumor markers were initially above the upper limit of normal (ULN)\]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)\*100.
dispersion Type
95% Confidence Interval
groups
  1. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 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
NUMBER
population Description
All randomized participants who received one dose of study drug.
reporting Status
POSTED
time Frame
Randomization to Measured PD (Up to 40 Months)
title
Percentage of Participants Achieving Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice