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NCT00859937 · OUTCOME

Response Rate

Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors · Source last updated 2018-04-20

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 2 months

What was measured

Response rate is percentage of the best overall response which recoded from the start of the treatment until diseases progression/recurrence. Response criteria are defined using the international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee: Complete Response, Disappearance of all target lesions; Partial Response, \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.

Analysis population: There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.

Groups in this outcome

Adenoid Cystic Carcinoma

Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Non Adenoid Cystic Carcinoma

Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Adenoid Cystic Carcinoma40
Non Adenoid Cystic Carcinoma14

Reported measurements

Complete response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adenoid Cystic Carcinoma0Not reportedNot reportedNot reportedNot reported
Non Adenoid Cystic Carcinoma0Not reportedNot reportedNot reportedNot reported
Partial response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adenoid Cystic Carcinoma1Not reportedNot reportedNot reportedNot reported
Non Adenoid Cystic Carcinoma0Not reportedNot reportedNot reportedNot reported
Stable disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adenoid Cystic Carcinoma20Not reportedNot reportedNot reportedNot reported
Non Adenoid Cystic Carcinoma7Not reportedNot reportedNot reportedNot reported
Progressive disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adenoid Cystic Carcinoma12Not reportedNot reportedNot reportedNot reported
Non Adenoid Cystic Carcinoma4Not reportedNot reportedNot reportedNot reported
Other
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adenoid Cystic Carcinoma7Not reportedNot reportedNot reportedNot reported
Non Adenoid Cystic Carcinoma3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Partial response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        7
    title
    Stable disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        4
    title
    Progressive disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        3
    title
    Other
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      14
    units
    Participants
description
Response rate is percentage of the best overall response which recoded from the start of the treatment until diseases progression/recurrence. Response criteria are defined using the international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee: Complete Response, Disappearance of all target lesions; Partial Response, \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.
groups
  1. description
    Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Adenoid Cystic Carcinoma
  2. description
    Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Non Adenoid Cystic Carcinoma
param Type
NUMBER
population Description
There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.
reporting Status
POSTED
time Frame
Up to 2 months
title
Response Rate
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice