PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Performed using snap frozen tissue samples using the well-established PamGene Kinase array platform available in the Salgia/Seiwert laboratories.

Data not collected

→

primary · POSTED

Maximum tolerated dose (MTD) is defined as the dose level preceding the dose in which greater than or equal to 2 out of 3-6 patients experience a dose limiting toxicity (DLT) assessed using CTCAE v4

0 patients out of 3 from the BKM 80mg/day cohort had DLT (dose limiting toxicities). 0 patients out of 9 from the BKM 100mg/day cohort had DLT.

→

secondary · POSTED

Measured by Terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay on Formalin-Fixed, Paraffin-Embedded (FFPE) sections in a descriptive manner.

Data not collected.

→

secondary · POSTED

Percentage of patients whose cancer shrinks or disappears after treatment.

Source null

→

secondary · POSTED

Percentage of patients with prior EGFR failure assessed using RECIST whose cancer shrinks or disappears after treatment.

Source null

→

secondary · POSTED

Tumor shrinkage will be visualized as a waterfall plot for graphical (qualitative) comparison.

Data not collected.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id: NCT01816984
trial label: PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01816984
outcome key
om-0000
source section id
NCT01816984-om-0000
source outcome index
0
endpoint
Compensatory Signaling/Feedback Loop Signaling Evaluated by Measurement of Phosphorylated (p)-EGFR
endpoint definition
Performed using snap frozen tissue samples using the well-established PamGene Kinase array platform available in the Salgia/Seiwert laboratories.
time origin
1 week
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Data not collected
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01816984
outcome key
om-0001
source section id
NCT01816984-om-0001
source outcome index
1
endpoint
Maximum Tolerated Dose (MTD)
endpoint definition
Maximum tolerated dose (MTD) is defined as the dose level preceding the dose in which greater than or equal to 2 out of 3-6 patients experience a dose limiting toxicity (DLT) assessed using CTCAE v4
time origin
28 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
0 patients out of 3 from the BKM 80mg/day cohort had DLT (dose limiting toxicities). 0 patients out of 9 from the BKM 100mg/day cohort had DLT.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01816984
outcome key
om-0002
source section id
NCT01816984-om-0002
source outcome index
2
endpoint
Apoptosis Induction
endpoint definition
Measured by Terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay on Formalin-Fixed, Paraffin-Embedded (FFPE) sections in a descriptive manner.
time origin
Up to 28 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Data not collected.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01816984
outcome key
om-0003
source section id
NCT01816984-om-0003
source outcome index
3
endpoint
Response Rate Assessed Using RECIST
endpoint definition
Percentage of patients whose cancer shrinks or disappears after treatment.
time origin
Up to 28 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01816984
outcome key
om-0004
source section id
NCT01816984-om-0004
source outcome index
4
endpoint
Response Rate in Patients With Prior EGFR Failure Assessed Using RECIST
endpoint definition
Percentage of patients with prior EGFR failure assessed using RECIST whose cancer shrinks or disappears after treatment.
time origin
Up to 28 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01816984
outcome key
om-0005
source section id
NCT01816984-om-0005
source outcome index
5
endpoint
Tumor Shrinkage
endpoint definition
Tumor shrinkage will be visualized as a waterfall plot for graphical (qualitative) comparison.
time origin
Up to 28 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Data not collected.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01816984
outcome key
om-0000
arm key
OG000
arm label
Arm I (BKM120 PO and Cetuximab 500 mg IV 14 Days)
regimen
Patients receive PI3K inhibitor BKM120 PO QD 100 mg/day on days -7 to 0. Patients complete 1 week washout. After dose escalation phase, 3 patients receive BKM120 PO 80mg / day and cetuximab 500 mg IV /14 days and 9 patients receive BKM120 PO 100mg / day and cetuximab 500 mg IV /14 days thereafter. All patients receive PI3K inhibitor BKM120 PO QD day on days 1-28 and cetuximab IV over 60-120 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K inhibitor BKM120: Given PO cetuximab: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01816984-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01816984
outcome key
om-0001
arm key
OG000
arm label
Arm I (BKM120 PO and Cetuximab 500 mg IV 14 Days)
regimen
Patients receive PI3K inhibitor BKM120 PO QD 100 mg/day on days -7 to 0. Patients complete 1 week washout. After dose escalation phase, 3 patients receive BKM120 PO 80mg / day and cetuximab 500 mg IV /14 days and 9 patients receive BKM120 PO 100mg / day and cetuximab 500 mg IV /14 days thereafter. All patients receive PI3K inhibitor BKM120 PO QD day on days 1-28 and cetuximab IV over 60-120 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K inhibitor BKM120: Given PO cetuximab: Given IV
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01816984-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01816984
outcome key
om-0002
arm key
OG000
arm label
Arm I (BKM120 PO and Cetuximab 500 mg IV 14 Days)
regimen
Patients receive PI3K inhibitor BKM120 PO QD 100 mg/day on days -7 to 0. Patients complete 1 week washout. After dose escalation phase, 3 patients receive BKM120 PO 80mg / day and cetuximab 500 mg IV /14 days and 9 patients receive BKM120 PO 100mg / day and cetuximab 500 mg IV /14 days thereafter. All patients receive PI3K inhibitor BKM120 PO QD day on days 1-28 and cetuximab IV over 60-120 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K inhibitor BKM120: Given PO cetuximab: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01816984-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01816984
outcome key
om-0003
arm key
OG000
arm label
Arm I (BKM120 PO and Cetuximab 500 mg IV 14 Days)
regimen
Patients receive PI3K inhibitor BKM120 PO QD 100 mg/day on days -7 to 0. Patients complete 1 week washout. After dose escalation phase, 3 patients receive BKM120 PO 80mg / day and cetuximab 500 mg IV /14 days and 9 patients receive BKM120 PO 100mg / day and cetuximab 500 mg IV /14 days thereafter. All patients receive PI3K inhibitor BKM120 PO QD day on days 1-28 and cetuximab IV over 60-120 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K inhibitor BKM120: Given PO cetuximab: Given IV
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01816984-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01816984
outcome key
om-0004
arm key
OG000
arm label
Arm I (BKM120 PO and Cetuximab 500 mg IV 14 Days)
regimen
Patients receive PI3K inhibitor BKM120 PO QD 100 mg/day on days -7 to 0. Patients complete 1 week washout. After dose escalation phase, 3 patients receive BKM120 PO 80mg / day and cetuximab 500 mg IV /14 days and 9 patients receive BKM120 PO 100mg / day and cetuximab 500 mg IV /14 days thereafter. All patients receive PI3K inhibitor BKM120 PO QD day on days 1-28 and cetuximab IV over 60-120 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K inhibitor BKM120: Given PO cetuximab: Given IV
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01816984-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01816984
outcome key
om-0005
arm key
OG000
arm label
Arm I (BKM120 PO and Cetuximab 500 mg IV 14 Days)
regimen
Patients receive PI3K inhibitor BKM120 PO QD 100 mg/day on days -7 to 0. Patients complete 1 week washout. After dose escalation phase, 3 patients receive BKM120 PO 80mg / day and cetuximab 500 mg IV /14 days and 9 patients receive BKM120 PO 100mg / day and cetuximab 500 mg IV /14 days thereafter. All patients receive PI3K inhibitor BKM120 PO QD day on days 1-28 and cetuximab IV over 60-120 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K inhibitor BKM120: Given PO cetuximab: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01816984-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01816984
harm key
EG000
source section id
NCT01816984-ae
event group key
EG000
event group label
Arm I (BKM120 PO and Cetuximab 500 mg IV 14 Days)
serious affected
4
serious at risk
12
other affected
12
other at risk
12
frequency threshold
5
collection period
4 years and 3 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice