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NCT00704730 · OUTCOME

Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined

Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer · Source last updated 2021-04-20

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
From time of first documentation of Objective Response (OR), confirmed at a later visit ≥28 days later as Progressive Disease (PD) as defined by mRECIST or death due to any cause, assessed up to 34 months.

What was measured

For those subjects with Independent Radiology Committee (IRC) determined Objective Response Rate (ORR), the amount of time from documentation of Objective Response (OR) until Progressive Disease (PD) by mRECIST or death due to any cause.

Analysis population: The primary analysis of Objective Response Rate (ORR) was performed among the subset of Intent To Treat (ITT) subjects with measurable disease at baseline and was based upon response as determined by the Independent Review Committee (IRC.) Subjects who did not have post-baseline adequate tumor assessments were counted as nonresponders.

Groups in this outcome

XL184 (Cabozantinib)

XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily

Placebo

Oral capsules once daily

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

Analysis denominator · Participants

GroupSource count
XL184 (Cabozantinib)58
Placebo0

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
XL184 (Cabozantinib)14.6Not reported11.117.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.1
        upper Limit
        17.5
        value
        14.6
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    2. group Id
      OG001
      value
      0
    units
    Participants
description
For those subjects with Independent Radiology Committee (IRC) determined Objective Response Rate (ORR), the amount of time from documentation of Objective Response (OR) until Progressive Disease (PD) by mRECIST or death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
    id
    OG000
    title
    XL184 (Cabozantinib)
  2. description
    Oral capsules once daily
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
The primary analysis of Objective Response Rate (ORR) was performed among the subset of Intent To Treat (ITT) subjects with measurable disease at baseline and was based upon response as determined by the Independent Review Committee (IRC.) Subjects who did not have post-baseline adequate tumor assessments were counted as nonresponders.
reporting Status
POSTED
time Frame
From time of first documentation of Objective Response (OR), confirmed at a later visit ≥28 days later as Progressive Disease (PD) as defined by mRECIST or death due to any cause, assessed up to 34 months.
title
Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice