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NCT00509002 · OUTCOME

Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy

Iressa Study in Patients With Salivary Gland Cancer · Source last updated 2017-11-24

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Every 4 weeks until progressive disease, unacceptable toxicity or patient withdrawal

What was measured

The modified Response Evaluation Criteria in Solid tumors (RECIST) criteria was used for objective tumor response assessment. Complete Response (CR): Disappearance all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): \>20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or \> new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Response rate estimated by Gehan's Phase II clinical trial design.

Groups in this outcome

Gefitinib

Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.

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

Analysis denominator · Participants

GroupSource count
Gefitinib37

Reported measurements

Source class 1

Complete Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gefitinib0Not reportedNot reportedNot reportedNot reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gefitinib0Not reportedNot reportedNot reportedNot reported

Stable Disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gefitinib18Not reportedNot reportedNot reportedNot reported

Progressive Disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gefitinib13Not reportedNot reportedNot reportedNot reported

Inevaluable

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gefitinib6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      title
      Complete Response
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Partial Response
    3. measurements
      1. group Id
        OG000
        value
        18
      title
      Stable Disease
    4. measurements
      1. group Id
        OG000
        value
        13
      title
      Progressive Disease
    5. measurements
      1. group Id
        OG000
        value
        6
      title
      Inevaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    units
    Participants
description
The modified Response Evaluation Criteria in Solid tumors (RECIST) criteria was used for objective tumor response assessment. Complete Response (CR): Disappearance all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): \>20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or \> new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Response rate estimated by Gehan's Phase II clinical trial design.
groups
  1. description
    Gefitinib 250 mg daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.
    id
    OG000
    title
    Gefitinib
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Every 4 weeks until progressive disease, unacceptable toxicity or patient withdrawal
title
Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice