NCT02113878 · OUTCOME

Maximum Tolerated Dose of BKM120

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
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

Group	Source count
Dose Level 1 and Dose Level 2	23

Reported measurements

Source class 1

Values in mg · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose Level 1 and Dose Level 2	40	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
40

denoms

counts
group Id
OG000
value
23
units
Participants

description

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

groups

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 BKM120

type

PRIMARY

unit Of Measure

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

Preserved source evidence · Not medical advice