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NCT00940225 · OUTCOME

Progression-Free Survival (PFS) - Randomized Stage, RDT Cohorts Only

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

Progression Free Survival during the Randomized Stage (Randomized Population)

Groups in this outcome

Randomized Phase - CRPC, Cabozantinib Arm

cabozantinib, 100 mg, po QD, ongoing until progression

Randomized Phase - CRPC, Placebo Arm

placebo 100mg, po QD, ongoing until progression

Randomized Phase - Melanoma, Cabozantinib Arm

cabozantinib, 100 mg, po QD, ongoing until progression

Randomized Phase - Melanoma, Placebo Arm

Placebo, 100mg, po QD, ongoing until progression

Randomized Phase - NSCLC, Cabozantinib Arm

cabozantinib, 100 mg, po QD, ongoing until progression

Randomized Phase - NSCLC, Placebo Arm

placebo, 100mg, po QD, ongoing until progression

Randomized Phase - Pancreatic Cancer, Cabozantinib Arm

cabozantinib, 100 mg, po QD, ongoing until progression

Randomized Phase - Pancreatic Cancer, Placebo Arm

placebo, 100mg, po QD, ongoing until progression

Randomized Phase - Gastric/GEJ, Cabozantinib Arm

cabozantinib, 100 mg, po QD, ongoing until progression

Randomized Phase - Gastric/GEJ , Placebo Arm

placebo, 100mg, po QD, ongoing until progression

Randomized Phase - HCC, Cabozantinib Arm

cabozantinib, 100 mg, po QD, ongoing until progression

Randomized Phase - HCC, Placebo Arm

placebo, 100 mg, po QD, ongoing until progression

Randomized Phase - SCLC, Cabozantinib Arm

cabozantinib, 100 mg, po QD, ongoing until progression

Randomized Phase - SCLC, Placebo Arm

placebo, 100 mg, po QD, ongoing until progression

Randomized Phase - Ovarian Cancer, Cabozantinib Arm

cabozantinib, 100 mg, po QD, ongoing until progression

Randomized Phase - Ovarian Cancer, Placebo Arm

placebo, 100 mg, po QD, ongoing until progression

Randomized Phase - MBC, Cabozantinib Arm

cabozantinib, 100 mg, po QD, ongoing until progression

Randomized Phase - MBC, Placebo Arm

placebo, 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
Randomized Phase - CRPC, Cabozantinib Arm14
Randomized Phase - CRPC, Placebo Arm17
Randomized Phase - Melanoma, Cabozantinib Arm13
Randomized Phase - Melanoma, Placebo Arm13
Randomized Phase - NSCLC, Cabozantinib Arm8
Randomized Phase - NSCLC, Placebo Arm8
Randomized Phase - Pancreatic Cancer, Cabozantinib Arm3
Randomized Phase - Pancreatic Cancer, Placebo Arm3
Randomized Phase - Gastric/GEJ, Cabozantinib Arm3
Randomized Phase - Gastric/GEJ , Placebo Arm2
Randomized Phase - HCC, Cabozantinib Arm10
Randomized Phase - HCC, Placebo Arm12
Randomized Phase - SCLC, Cabozantinib Arm8
Randomized Phase - SCLC, Placebo Arm2
Randomized Phase - Ovarian Cancer, Cabozantinib Arm7
Randomized Phase - Ovarian Cancer, Placebo Arm6
Randomized Phase - MBC, Cabozantinib Arm5
Randomized Phase - MBC, Placebo Arm5

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized Phase - CRPC, Cabozantinib Arm5.5Not reported4.08.5Not reported
Randomized Phase - CRPC, Placebo Arm1.4Not reported1.252.73Not reported
Randomized Phase - Melanoma, Cabozantinib Arm4.5Not reported1.815.4Not reported
Randomized Phase - Melanoma, Placebo Arm2.8Not reported1.455.45Not reported
Randomized Phase - NSCLC, Cabozantinib Arm2.4Not reported1.32.9Not reported
Randomized Phase - NSCLC, Placebo Arm2.4Not reported1.42.7Not reported
Randomized Phase - Pancreatic Cancer, Cabozantinib Arm2.8Not reported1.52.8Not reported
Randomized Phase - Pancreatic Cancer, Placebo Arm.07Not reported.07.07Not reported
Randomized Phase - Gastric/GEJ, Cabozantinib ArmNANot reported2.3NAThere was only one out of three subjects evaluated; unable to estimate due to insufficient number of patients within cohort.
Randomized Phase - Gastric/GEJ , Placebo Arm1.0Not reported.721.38Not reported
Randomized Phase - HCC, Cabozantinib Arm2.5Not reported1.36.8Not reported
Randomized Phase - HCC, Placebo Arm1.4Not reported1.34.2Not reported
Randomized Phase - SCLC, Cabozantinib Arm5.5Not reported1.96.9Not reported
Randomized Phase - SCLC, Placebo Arm1.5Not reported.852.23Not reported
Randomized Phase - Ovarian Cancer, Cabozantinib Arm4.9Not reported3.913.6Not reported
Randomized Phase - Ovarian Cancer, Placebo Arm1.4Not reported1.31.6Not reported
Randomized Phase - MBC, Cabozantinib Arm6.9Not reported5.113.5Not reported
Randomized Phase - MBC, Placebo Arm1.1Not reported.71.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.0
        upper Limit
        8.5
        value
        5.5
      2. group Id
        OG001
        lower Limit
        1.25
        upper Limit
        2.73
        value
        1.4
      3. group Id
        OG002
        lower Limit
        1.8
        upper Limit
        15.4
        value
        4.5
      4. group Id
        OG003
        lower Limit
        1.45
        upper Limit
        5.45
        value
        2.8
      5. group Id
        OG004
        lower Limit
        1.3
        upper Limit
        2.9
        value
        2.4
      6. group Id
        OG005
        lower Limit
        1.4
        upper Limit
        2.7
        value
        2.4
      7. group Id
        OG006
        lower Limit
        1.5
        upper Limit
        2.8
        value
        2.8
      8. group Id
        OG007
        lower Limit
        .07
        upper Limit
        .07
        value
        .07
      9. comment
        There was only one out of three subjects evaluated; unable to estimate due to insufficient number of patients within cohort.
        group Id
        OG008
        lower Limit
        2.3
        upper Limit
        NA
        value
        NA
      10. group Id
        OG009
        lower Limit
        .72
        upper Limit
        1.38
        value
        1.0
      11. group Id
        OG010
        lower Limit
        1.3
        upper Limit
        6.8
        value
        2.5
      12. group Id
        OG011
        lower Limit
        1.3
        upper Limit
        4.2
        value
        1.4
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      17
    3. group Id
      OG002
      value
      13
    4. group Id
      OG003
      value
      13
    5. group Id
      OG004
      value
      8
    6. group Id
      OG005
      value
      8
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      2
    11. group Id
      OG010
      value
      10
    12. group Id
      OG011
      value
      12
    units
    Participants
description
Progression Free Survival during the Randomized Stage (Randomized Population)
dispersion Type
95% Confidence Interval
groups
  1. description
    cabozantinib, 100 mg, po QD, ongoing until progression
    id
    OG000
    title
    Randomized Phase - CRPC, Cabozantinib Arm
  2. description
    placebo 100mg, po QD, ongoing until progression
    id
    OG001
    title
    Randomized Phase - CRPC, Placebo Arm
  3. description
    cabozantinib, 100 mg, po QD, ongoing until progression
    id
    OG002
    title
    Randomized Phase - Melanoma, Cabozantinib Arm
  4. description
    Placebo, 100mg, po QD, ongoing until progression
    id
    OG003
    title
    Randomized Phase - Melanoma, Placebo Arm
  5. description
    cabozantinib, 100 mg, po QD, ongoing until progression
    id
    OG004
    title
    Randomized Phase - NSCLC, Cabozantinib Arm
  6. description
    placebo, 100mg, po QD, ongoing until progression
    id
    OG005
    title
    Randomized Phase - NSCLC, Placebo Arm
  7. description
    cabozantinib, 100 mg, po QD, ongoing until progression
    id
    OG006
    title
    Randomized Phase - Pancreatic Cancer, Cabozantinib Arm
  8. description
    placebo, 100mg, po QD, ongoing until progression
    id
    OG007
    title
    Randomized Phase - Pancreatic Cancer, Placebo Arm
  9. description
    cabozantinib, 100 mg, po QD, ongoing until progression
    id
    OG008
    title
    Randomized Phase - Gastric/GEJ, Cabozantinib Arm
  10. description
    placebo, 100mg, po QD, ongoing until progression
    id
    OG009
    title
    Randomized Phase - Gastric/GEJ , Placebo Arm
  11. description
    cabozantinib, 100 mg, po QD, ongoing until progression
    id
    OG010
    title
    Randomized Phase - HCC, Cabozantinib Arm
  12. description
    placebo, 100 mg, po QD, ongoing until progression
    id
    OG011
    title
    Randomized Phase - HCC, Placebo Arm
param Type
MEDIAN
reporting Status
POSTED
time Frame
From initial dose through final study visit up to 44 months
title
Progression-Free Survival (PFS) - Randomized Stage, RDT Cohorts Only
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice