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NCT01831726 · OUTCOME

Clinical Benefit Rate (CBR)

Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib · Source last updated 2017-03-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
number of participants
Interval / dispersion
Not reported
Time frame
Week 16

What was measured

CBR determined by investigator assessment for each tumor assessment \& defined as responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) ≥ 16 wks. Confirmed CR/PR or SD prior to 16 wks,but discontinued prior to 16 wks for reasons other than progressive disease,will have their clinical benefit defined non-evaluable; confirmed CR/PR or SD prior to 16 wks,but progressed prior to 16 wks,will be considered not achieving clinical benefit;if CR/PR/SD occurred prior to 16 wks,but progressed at or after 16 wks without evidence of CR/PR/SD at or after 16 wks,will also be considered not achieving clinical benefit. CBR will be analyzed by comparing achieved CBR with a historical control rate of each tumor type,\& if there is at least 90% probability that the response rate in a tumor type exceeds the historical rate,then the tumor type will be considered a success. CBR: CR+PR+SD the assessment criteria was RECIST 1.1

Analysis population: Full Analysis Set (FAS) included all patients who received at least one dose of study drug. FAS was used for the analysis of efficacy endpoints.

Groups in this outcome

TKI258

Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.

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

Analysis denominator · Participants

GroupSource count
TKI25880

Reported measurements

Complete response (CR)
Values in number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TKI2580Not reportedNot reportedNot reportedNot reported
Partial response (PR)
Values in number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TKI2581Not reportedNot reportedNot reportedNot reported
Stable disease (SD)
Values in number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TKI25810Not reportedNot reportedNot reportedNot reported
Clinical benefit rate (CBR)
Values in number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TKI25811Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Partial response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Stable disease (SD)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Clinical benefit rate (CBR)
denoms
  1. counts
    1. group Id
      OG000
      value
      80
    units
    Participants
description
CBR determined by investigator assessment for each tumor assessment \& defined as responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) ≥ 16 wks. Confirmed CR/PR or SD prior to 16 wks,but discontinued prior to 16 wks for reasons other than progressive disease,will have their clinical benefit defined non-evaluable; confirmed CR/PR or SD prior to 16 wks,but progressed prior to 16 wks,will be considered not achieving clinical benefit;if CR/PR/SD occurred prior to 16 wks,but progressed at or after 16 wks without evidence of CR/PR/SD at or after 16 wks,will also be considered not achieving clinical benefit. CBR will be analyzed by comparing achieved CBR with a historical control rate of each tumor type,\& if there is at least 90% probability that the response rate in a tumor type exceeds the historical rate,then the tumor type will be considered a success. CBR: CR+PR+SD the assessment criteria was RECIST 1.1
groups
  1. description
    Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
    id
    OG000
    title
    TKI258
param Type
NUMBER
population Description
Full Analysis Set (FAS) included all patients who received at least one dose of study drug. FAS was used for the analysis of efficacy endpoints.
reporting Status
POSTED
time Frame
Week 16
title
Clinical Benefit Rate (CBR)
type
PRIMARY
unit Of Measure
number of participants

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

Preserved source evidence · Not medical advice