Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00704730 · OUTCOME

Biochemical Response Carcinoembryonic Antigen (CEA) %

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
NUMBER
Unit
% of participants
Interval / dispersion
Not reported
Time frame
Serum tumor markers CEA evaluated from blood samples collected at screening and every 12 weeks (± 5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.

What was measured

For each on-treatment tumor marker assessment from each subject, the biochemical response of CEA was determined based on percent increase or decrease from baseline. Best biochemical response over the course of treatment was determined from evaluation of each subject's time point response data. Biochemical response: Complete Response (CR)- Decrease in tumor marker into normal range from baseline value; Partial Response (PR)- Decrease of \>50% from baseline value when baseline value is above normal range; Stable Disease (SD)- No more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD)- Increase of \>50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE)- Missing baseline value / or baseline value is not elevated and response is not Progressive Disease (PD) / or response can not be determined due to change in assay format.

Analysis population: For the CEA measure the analysis population differs from the Intent To Treat (ITT) population of 219 XL184 and 111 Placebo. One subject did not provide samples for CEA. The biomarker analysis was based on available samples, not on ITT.

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)218
Placebo111

Reported measurements

Source class 1
Values in % of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
XL184 (Cabozantinib)21.658.21Not reportedNot reportedNot reported
Placebo0.9182.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        58.21
        value
        21.6
      2. group Id
        OG001
        spread
        182.6
        value
        0.9
denoms
  1. counts
    1. group Id
      OG000
      value
      218
    2. group Id
      OG001
      value
      111
    units
    Participants
description
For each on-treatment tumor marker assessment from each subject, the biochemical response of CEA was determined based on percent increase or decrease from baseline. Best biochemical response over the course of treatment was determined from evaluation of each subject's time point response data. Biochemical response: Complete Response (CR)- Decrease in tumor marker into normal range from baseline value; Partial Response (PR)- Decrease of \>50% from baseline value when baseline value is above normal range; Stable Disease (SD)- No more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD)- Increase of \>50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE)- Missing baseline value / or baseline value is not elevated and response is not Progressive Disease (PD) / or response can not be determined due to change in assay format.
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
NUMBER
population Description
For the CEA measure the analysis population differs from the Intent To Treat (ITT) population of 219 XL184 and 111 Placebo. One subject did not provide samples for CEA. The biomarker analysis was based on available samples, not on ITT.
reporting Status
POSTED
time Frame
Serum tumor markers CEA evaluated from blood samples collected at screening and every 12 weeks (± 5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.
title
Biochemical Response Carcinoembryonic Antigen (CEA) %
type
SECONDARY
unit Of Measure
% of participants

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

Preserved source evidence · Not medical advice