SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes

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

best response of PR or CR observed within 6 months of enrollment

Source null

→

secondary · POSTED

Number of Participants With Treatment-related Adverse Events

Source null

→

secondary · POSTED

To Assess the Effect of SF1126 on Time to Progression.

Source null

→

secondary · POSTED

To Assess the Effect of SF1126 on Overall Survival.

Source null

→

secondary · POSTED

To Assess Disease-related Patient-reported Outcomes Using the EORTC-QLQ-

Source null

→

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

EORTC QLQ · To Assess Disease-related Patient-reported Outcomes Using the EORTC-QLQ-

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-9dfacc13
nct id: NCT02644122
qol key: qol-0004
source section id: NCT02644122-om-0004
source outcome index: 4
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: To Assess Disease-related Patient-reported Outcomes Using the EORTC-QLQ-
measure definition: Source null
time frame: 4 years
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Source null
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

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-9dfacc13
nct id: NCT02644122
trial label: SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes
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: 5
harms Count: 1
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-9dfacc13
nct id
NCT02644122
outcome key
om-0000
source section id
NCT02644122-om-0000
source outcome index
0
endpoint
To Determine ORR
endpoint definition
best response of PR or CR observed within 6 months of enrollment
time origin
6 months
analysis role
primary
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-9dfacc13
nct id
NCT02644122
outcome key
om-0001
source section id
NCT02644122-om-0001
source outcome index
1
endpoint
Number of Participants With Treatment-related Adverse Events
endpoint definition
Number of Participants With Treatment-related Adverse Events
time origin
4 years
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-9dfacc13
nct id
NCT02644122
outcome key
om-0002
source section id
NCT02644122-om-0002
source outcome index
2
endpoint
To Assess the Effect of SF1126 on Time to Progression.
endpoint definition
To Assess the Effect of SF1126 on Time to Progression.
time origin
4 years
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-9dfacc13
nct id
NCT02644122
outcome key
om-0003
source section id
NCT02644122-om-0003
source outcome index
3
endpoint
To Assess the Effect of SF1126 on Overall Survival.
endpoint definition
To Assess the Effect of SF1126 on Overall Survival.
time origin
4 years
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-9dfacc13
nct id
NCT02644122
outcome key
om-0004
source section id
NCT02644122-om-0004
source outcome index
4
endpoint
To Assess Disease-related Patient-reported Outcomes Using the EORTC-QLQ-
endpoint definition
To Assess Disease-related Patient-reported Outcomes Using the EORTC-QLQ-
time origin
4 years
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

arms

release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-9dfacc13
nct id
NCT02644122
outcome key
om-0000
arm key
OG000
arm label
SF1126
regimen
SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02644122-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-9dfacc13
nct id
NCT02644122
outcome key
om-0001
arm key
OG000
arm label
SF1126
regimen
SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles. SF1126
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02644122-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-9dfacc13
nct id
NCT02644122
outcome key
om-0002
arm key
OG000
arm label
SF1126
regimen
SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02644122-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-9dfacc13
nct id
NCT02644122
outcome key
om-0003
arm key
OG000
arm label
SF1126
regimen
SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02644122-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-9dfacc13
nct id
NCT02644122
outcome key
om-0004
arm key
OG000
arm label
SF1126
regimen
SF1126 1110 mg/m2 administered intravenously (IV) twice per week (separated by at least three days) for the first four treatment cycles (28 days) and then once weekly for subsequent cycles.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02644122-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-9dfacc13
nct id
NCT02644122
harm key
EG000
source section id
NCT02644122-ae
event group key
EG000
event group label
SF1126
serious affected
1
serious at risk
1
other affected
1
other at risk
1
frequency threshold
0
collection period
Source null
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

release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-9dfacc13
nct id
NCT02644122
qol key
qol-0004
source section id
NCT02644122-om-0004
source outcome index
4
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
To Assess Disease-related Patient-reported Outcomes Using the EORTC-QLQ-
measure definition
Source null
time frame
4 years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice