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NCT02113878 · OUTCOME

Median Depression Score Change

Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck · Source last updated 2024-11-05

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

Measure
MEDIAN
Unit
points
Interval / dispersion
Full Range
Time frame
From baseline to cycle 9, up to 66 days.

What was measured

The median change in score on the Patient Health Questionnaire - 9 (PHQ-8) from baseline to cycle 9. PHQ-9 has 9 questions and each question has score from 0 to 3. Sum score of all questions will be used as the final score. The final score ranges from 0 to 27. Higher score represents worse depression.

Groups in this outcome

Dose Level 1

* 40 mg BKM120 will be administered orally daily for 45 days. Starting dose 40 mg. * Cisplatin: Starting Dose 30 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells

Dose Level 2

* 40 mg BKM120 will be administered orally daily for 45 days. * Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells

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

Analysis denominator · Participants

GroupSource count
Dose Level 117
Dose Level 26

Reported measurements

Source class 1
Values in points · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose Level 11Not reported-49Not reported
Dose Level 20Not reported-80Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -4
        upper Limit
        9
        value
        1
      2. group Id
        OG001
        lower Limit
        -8
        upper Limit
        0
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      6
    units
    Participants
description
The median change in score on the Patient Health Questionnaire - 9 (PHQ-8) from baseline to cycle 9. PHQ-9 has 9 questions and each question has score from 0 to 3. Sum score of all questions will be used as the final score. The final score ranges from 0 to 27. Higher score represents worse depression.
dispersion Type
Full Range
groups
  1. description
    * 40 mg BKM120 will be administered orally daily for 45 days. Starting dose 40 mg. * Cisplatin: Starting Dose 30 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
    id
    OG000
    title
    Dose Level 1
  2. description
    * 40 mg BKM120 will be administered orally daily for 45 days. * Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43). * Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks. BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
    id
    OG001
    title
    Dose Level 2
param Type
MEDIAN
reporting Status
POSTED
time Frame
From baseline to cycle 9, up to 66 days.
title
Median Depression Score Change
type
SECONDARY
unit Of Measure
points

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

Preserved source evidence · Not medical advice