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NCT02196168 · OUTCOME

Levels of Pharmacodynamic Biomarkers

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Pre-dose, at 4-8 hours on day 3 or 20-24 hours on day 4

What was measured

Predictors of clinical outcomes will be investigated using logistic regression, Cox proportional hazards regression and/or generalized estimating equations as appropriate. Descriptive statistics and plotting of data will be used to better understand potential relationships.

Analysis population: No data are available as decision was made by PI not to do the analysis due to small number of patients

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)0
Arm II (Placebo, Cisplatin)0

Reported measurements

Source class 1
Values in Not reported · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)0Not reportedNot reportedNot reportedNot reported
Arm II (Placebo, Cisplatin)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Predictors of clinical outcomes will be investigated using logistic regression, Cox proportional hazards regression and/or generalized estimating equations as appropriate. Descriptive statistics and plotting of data will be used to better understand potential relationships.
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)
population Description
No data are available as decision was made by PI not to do the analysis due to small number of patients
reporting Status
POSTED
time Frame
Pre-dose, at 4-8 hours on day 3 or 20-24 hours on day 4
title
Levels of Pharmacodynamic Biomarkers
type
SECONDARY

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

Preserved source evidence · Not medical advice