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NCT00940225 · OUTCOME

Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort 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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From initial dose through final study visit up to 44 months

What was measured

Objective response rate (ORR) per modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.0 per investigator The analysis of ORR in the RDT Cohorts were defined as the proportion of subjects with a best overall response of confirmed complete response (CR) or partial response (PR) per mRECIST 1.0 during the 12-week Lead-In Stage. In the NRE Ovarian Cohort, mRECIST 1.1 was used. ORR for the NRE CRPC Cohorts was not a primary objective and is therefore not captured in the table below.

Groups in this outcome

Lead-in Stage - CRPC

cabozantinib, 100 mg, po QD for 12 weeks

Lead-in Stage - Melanoma

cabozantinib, 100 mg, po QD for 12 weeks

Lead-in Stage - NSCLC

cabozantinib, 100 mg, po QD for 12 weeks

Lead-in Stage - Pancreatic Cancer

cabozantinib, 100 mg, po QD for 12 weeks

Lead-in Stage - Gastric/GEJ

cabozantinib, 100 mg, po QD for 12 weeks

Lead-in Stage - Hepatocellular Carcinoma

cabozantinib, 100 mg, po QD for 12 weeks

Lead-in Stage - SCLC

cabozantinib, 100 mg, po QD for 12 weeks

Lead-in Stage - Ovarian Cancer

cabozantinib, 100 mg, po QD for 12 weeks

Lead-in Stage - Metastatic Breast Cancer

cabozantinib, 100 mg, po QD for 12 weeks

Lead-in Stage - NRE Ovarian Cancer

cabozantinib, 100 mg, po QD for 12 weeks

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

Analysis denominator · Participants

GroupSource count
Lead-in Stage - CRPC171
Lead-in Stage - Melanoma77
Lead-in Stage - NSCLC60
Lead-in Stage - Pancreatic Cancer20
Lead-in Stage - Gastric/GEJ21
Lead-in Stage - Hepatocellular Carcinoma41
Lead-in Stage - SCLC21
Lead-in Stage - Ovarian Cancer70
Lead-in Stage - Metastatic Breast Cancer45
Lead-in Stage - NRE Ovarian Cancer60

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lead-in Stage - CRPC4.7Not reported2.08.7Not reported
Lead-in Stage - Melanoma5.2Not reported1.812.4Not reported
Lead-in Stage - NSCLC10Not reported4.420.3Not reported
Lead-in Stage - Pancreatic Cancer0Not reported015.4Not reported
Lead-in Stage - Gastric/GEJ4.8Not reported0.221.8Not reported
Lead-in Stage - Hepatocellular Carcinoma4.9Not reported0.916.1Not reported
Lead-in Stage - SCLC4.8Not reported0.221.8Not reported
Lead-in Stage - Ovarian Cancer21.7Not reported13.132.4Not reported
Lead-in Stage - Metastatic Breast Cancer13.6Not reported6.025.7Not reported
Lead-in Stage - NRE Ovarian Cancer10.0Not reported3.321.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        8.7
        value
        4.7
      2. group Id
        OG001
        lower Limit
        1.8
        upper Limit
        12.4
        value
        5.2
      3. group Id
        OG002
        lower Limit
        4.4
        upper Limit
        20.3
        value
        10
      4. group Id
        OG003
        lower Limit
        0
        upper Limit
        15.4
        value
        0
      5. group Id
        OG004
        lower Limit
        0.2
        upper Limit
        21.8
        value
        4.8
      6. group Id
        OG005
        lower Limit
        0.9
        upper Limit
        16.1
        value
        4.9
      7. group Id
        OG006
        lower Limit
        0.2
        upper Limit
        21.8
        value
        4.8
      8. group Id
        OG007
        lower Limit
        13.1
        upper Limit
        32.4
        value
        21.7
      9. group Id
        OG008
        lower Limit
        6.0
        upper Limit
        25.7
        value
        13.6
      10. group Id
        OG009
        lower Limit
        3.3
        upper Limit
        21.8
        value
        10.0
denoms
  1. counts
    1. group Id
      OG000
      value
      171
    2. group Id
      OG001
      value
      77
    3. group Id
      OG002
      value
      60
    4. group Id
      OG003
      value
      20
    5. group Id
      OG004
      value
      21
    6. group Id
      OG005
      value
      41
    7. group Id
      OG006
      value
      21
    8. group Id
      OG007
      value
      70
    9. group Id
      OG008
      value
      45
    10. group Id
      OG009
      value
      60
    units
    Participants
description
Objective response rate (ORR) per modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.0 per investigator The analysis of ORR in the RDT Cohorts were defined as the proportion of subjects with a best overall response of confirmed complete response (CR) or partial response (PR) per mRECIST 1.0 during the 12-week Lead-In Stage. In the NRE Ovarian Cohort, mRECIST 1.1 was used. ORR for the NRE CRPC Cohorts was not a primary objective and is therefore not captured in the table below.
dispersion Type
95% Confidence Interval
groups
  1. description
    cabozantinib, 100 mg, po QD for 12 weeks
    id
    OG000
    title
    Lead-in Stage - CRPC
  2. description
    cabozantinib, 100 mg, po QD for 12 weeks
    id
    OG001
    title
    Lead-in Stage - Melanoma
  3. description
    cabozantinib, 100 mg, po QD for 12 weeks
    id
    OG002
    title
    Lead-in Stage - NSCLC
  4. description
    cabozantinib, 100 mg, po QD for 12 weeks
    id
    OG003
    title
    Lead-in Stage - Pancreatic Cancer
  5. description
    cabozantinib, 100 mg, po QD for 12 weeks
    id
    OG004
    title
    Lead-in Stage - Gastric/GEJ
  6. description
    cabozantinib, 100 mg, po QD for 12 weeks
    id
    OG005
    title
    Lead-in Stage - Hepatocellular Carcinoma
  7. description
    cabozantinib, 100 mg, po QD for 12 weeks
    id
    OG006
    title
    Lead-in Stage - SCLC
  8. description
    cabozantinib, 100 mg, po QD for 12 weeks
    id
    OG007
    title
    Lead-in Stage - Ovarian Cancer
  9. description
    cabozantinib, 100 mg, po QD for 12 weeks
    id
    OG008
    title
    Lead-in Stage - Metastatic Breast Cancer
  10. description
    cabozantinib, 100 mg, po QD for 12 weeks
    id
    OG009
    title
    Lead-in Stage - NRE Ovarian Cancer
param Type
NUMBER
reporting Status
POSTED
time Frame
From initial dose through final study visit up to 44 months
title
Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice