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NCT02196168 · OUTCOME

Progression Free Survival

Cisplatin With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer · Source last updated 2017-05-03

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months

What was measured

Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression (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) or death, whichever occurs first.

Groups in this outcome

Arm I (WEE1 Inhibitor MK-1775, Cisplatin)

Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies WEE1 Inhibitor AZD1775: Given PO

Arm II (Placebo, Cisplatin)

Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO

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

Analysis denominator · Participants

GroupSource count
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)6
Arm II (Placebo, Cisplatin)0

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)2.88Not reported0.99NAThe upper limit for Measure of Dispersion was 'not reached' for this study
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit for Measure of Dispersion was 'not reached' for this study
        group Id
        OG000
        lower Limit
        0.99
        upper Limit
        NA
        value
        2.88
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression (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) or death, whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies WEE1 Inhibitor AZD1775: Given PO
    id
    OG000
    title
    Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
  2. description
    Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO
    id
    OG001
    title
    Arm II (Placebo, Cisplatin)
param Type
MEDIAN
reporting Status
POSTED
time Frame
Time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months
title
Progression Free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice