Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02113878 · OUTCOME

Maximum Tolerated Dose of Cisplatin

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
NUMBER
Unit
mg/m2
Interval / dispersion
Not reported
Time frame
While on treatment, up to 66 days

What was measured

The trial uses 3+3 design to determine maximum tolerated dose (MTD).

Analysis population: \*One additional patient enrolled in Dose Level 1 per physician discretion

Groups in this outcome

Dose Level 1 and Dose Level 2

* 40 mg BKM120 will be administered orally daily for 45 days. * Cisplatin: Starting Dose 30 mg/m2 (Dose Level 1) or 35 mg/m2 (Dose Level 2), 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 1 and Dose Level 223

Reported measurements

Source class 1
Values in mg/m2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 and Dose Level 230Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        30
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    units
    Participants
description
The trial uses 3+3 design to determine maximum tolerated dose (MTD).
groups
  1. description
    * 40 mg BKM120 will be administered orally daily for 45 days. * Cisplatin: Starting Dose 30 mg/m2 (Dose Level 1) or 35 mg/m2 (Dose Level 2), 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 and Dose Level 2
param Type
NUMBER
population Description
\*One additional patient enrolled in Dose Level 1 per physician discretion
reporting Status
POSTED
time Frame
While on treatment, up to 66 days
title
Maximum Tolerated Dose of Cisplatin
type
PRIMARY
unit Of Measure
mg/m2

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

Preserved source evidence · Not medical advice