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NCT00387335 · OUTCOME

Objective Tumor Response Rate (Complete Response [CR] and Partial Response [PR]) Using RECIST Criteria

Sunitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer · Source last updated 2014-07-25

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
While patient remains on treatment, up to 30 weeks

What was measured

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Groups in this outcome

Sunitinib -- Cohort A

Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Sunitinib -- Cohort B

Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Sunitinib -- Cohort A15
Sunitinib -- Cohort B7

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sunitinib -- Cohort A6.7Not reported0.231.9Not reported
Sunitinib -- Cohort B0Not reported041.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.2
        upper Limit
        31.9
        value
        6.7
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        41.0
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Sunitinib -- Cohort A
  2. description
    Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Sunitinib -- Cohort B
param Type
NUMBER
reporting Status
POSTED
time Frame
While patient remains on treatment, up to 30 weeks
title
Objective Tumor Response Rate (Complete Response [CR] and Partial Response [PR]) Using RECIST Criteria
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice