NCT02113878 · OUTCOME

P13K Status by Response

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Biopsies drawn up to 10 days from registration. Response measured at from baseline to cycle 9, up to 66 days.

What was measured

Phosphoinositide 3-kinase (PI3K) biomarker status, either positive or negative, analyzed using established methods from tumor biopsies. P13K status is reported by response, either responder (CR or PR) or non-responder (SD or PR).

Analysis population: Biomarker data was not collected for all patients. Data reported for all patients who were biopsied.

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

Group	Source count
Dose Level 1	15
Dose Level 2	4

Reported measurements

P13K Positive - Responder

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

P13K Positive - Non-Responder

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

P13K Negative - Responder

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose Level 1	9	Not reported	Not reported	Not reported	Not reported
Dose Level 2	1	Not reported	Not reported	Not reported	Not reported

P13K Negative - Non-Responder

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose Level 1	3	Not reported	Not reported	Not reported	Not reported
Dose Level 2	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
title
P13K Positive - Responder
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
P13K Positive - Non-Responder
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
1
title
P13K Negative - Responder
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
title
P13K Negative - Non-Responder

denoms

counts
group Id
OG000
value
15
group Id
OG001
value
4
units
Participants

description

groups

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
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

COUNT_OF_PARTICIPANTS

population Description

Biomarker data was not collected for all patients. Data reported for all patients who were biopsied.

reporting Status

POSTED

time Frame

Biopsies drawn up to 10 days from registration. Response measured at from baseline to cycle 9, up to 66 days.

title

P13K Status by Response

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice