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NCT00704730 · OUTCOME

Progression-Free Survival (PFS)

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
Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months.

What was measured

The duration of Progression-Free Survival (PFS) using progression events as determined by Independent Review Committee (IRC) per mRECIST, or death due to any cause. The analysis was conducted after at least 315 subjects were randomized and at least 138 events were observed.

Analysis population: Intent to Treat (ITT) 330 subjects were randomized and were included in the analysis. A Kaplan-Meyer analysis was performed to estimate the median.

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)219
Placebo111

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
XL184 (Cabozantinib)11.2Not reported9.313.7Not reported
Placebo4.0Not reported3.05.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.3
        upper Limit
        13.7
        value
        11.2
      2. group Id
        OG001
        lower Limit
        3.0
        upper Limit
        5.4
        value
        4.0
denoms
  1. counts
    1. group Id
      OG000
      value
      219
    2. group Id
      OG001
      value
      111
    units
    Participants
description
The duration of Progression-Free Survival (PFS) using progression events as determined by Independent Review Committee (IRC) per mRECIST, or death due to any cause. The analysis was conducted after at least 315 subjects were randomized and at least 138 events were observed.
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
Intent to Treat (ITT) 330 subjects were randomized and were included in the analysis. A Kaplan-Meyer analysis was performed to estimate the median.
reporting Status
POSTED
time Frame
Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months.
title
Progression-Free Survival (PFS)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice