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NCT00940225 · OUTCOME

Duration of Objective Response (OR) - Responders From Lead-in Stage

Study of Cabozantinib (XL184) in Adults With Advanced Malignancies · Source last updated 2024-04-25

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 initial dose through final study visit up to 44 months

What was measured

Duration of objective response was defined as the time from the tumor assessment that first documented PR or CR that was subsequently confirmed at least 28 days later until the date of documented progression. There were either few or no responders in the Gastric/GEJ, SCLC, and pancreatic cohorts so these cohorts are excluded.

Groups in this outcome

CRPC

cabozantinib, 100 mg, po QD ongoing until progression

Melanoma

cabozantinib, 100 mg, po QD ongoing until progression

NSCLC

cabozantinib, 100 mg, po QD ongoing until progression

Hepatocellular Carcinoma

cabozantinib, 100 mg, po QD ongoing until progression

Ovarian Cancer

cabozantinib, 100 mg, po QD ongoing until progression

Metastatic Breast Cancer

cabozantinib, 100 mg, po QD ongoing until progression

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

Analysis denominator · Participants

GroupSource count
CRPC15
Melanoma6
NSCLC6
Hepatocellular Carcinoma3
Ovarian Cancer15
Metastatic Breast Cancer6

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CRPC5.59Not reported4.278.34Not reported
Melanoma5.55Not reported2.9913.86Not reported
NSCLC6.90Not reported5.2910.74Not reported
Hepatocellular Carcinoma4.21Not reported2.99NAUnable to estimate due to low numbers.
Ovarian Cancer11.24Not reported7.20NAUnable to estimate due to low numbers.
Metastatic Breast Cancer3.29Not reported2.794.21Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.27
        upper Limit
        8.34
        value
        5.59
      2. group Id
        OG001
        lower Limit
        2.99
        upper Limit
        13.86
        value
        5.55
      3. group Id
        OG002
        lower Limit
        5.29
        upper Limit
        10.74
        value
        6.90
      4. comment
        Unable to estimate due to low numbers.
        group Id
        OG003
        lower Limit
        2.99
        upper Limit
        NA
        value
        4.21
      5. comment
        Unable to estimate due to low numbers.
        group Id
        OG004
        lower Limit
        7.20
        upper Limit
        NA
        value
        11.24
      6. group Id
        OG005
        lower Limit
        2.79
        upper Limit
        4.21
        value
        3.29
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      15
    6. group Id
      OG005
      value
      6
    units
    Participants
description
Duration of objective response was defined as the time from the tumor assessment that first documented PR or CR that was subsequently confirmed at least 28 days later until the date of documented progression. There were either few or no responders in the Gastric/GEJ, SCLC, and pancreatic cohorts so these cohorts are excluded.
dispersion Type
95% Confidence Interval
groups
  1. description
    cabozantinib, 100 mg, po QD ongoing until progression
    id
    OG000
    title
    CRPC
  2. description
    cabozantinib, 100 mg, po QD ongoing until progression
    id
    OG001
    title
    Melanoma
  3. description
    cabozantinib, 100 mg, po QD ongoing until progression
    id
    OG002
    title
    NSCLC
  4. description
    cabozantinib, 100 mg, po QD ongoing until progression
    id
    OG003
    title
    Hepatocellular Carcinoma
  5. description
    cabozantinib, 100 mg, po QD ongoing until progression
    id
    OG004
    title
    Ovarian Cancer
  6. description
    cabozantinib, 100 mg, po QD ongoing until progression
    id
    OG005
    title
    Metastatic Breast Cancer
param Type
MEDIAN
reporting Status
POSTED
time Frame
From initial dose through final study visit up to 44 months
title
Duration of Objective Response (OR) - Responders From Lead-in Stage
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice