TriangleNCT01816984 · STUDY IN CONTEXT
PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
Performed using snap frozen tissue samples using the well-established PamGene Kinase array platform available in the Salgia/Seiwert laboratories.
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
Measured by Terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay on Formalin-Fixed, Paraffin-Embedded (FFPE) sections in a descriptive manner.
Percentage of patients whose cancer shrinks or disappears after treatment.
Percentage of patients with prior EGFR failure assessed using RECIST whose cancer shrinks or disappears after treatment.
Tumor shrinkage will be visualized as a waterfall plot for graphical (qualitative) comparison.
Reported safety
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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT01816984
- trial label
- PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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