NCT00387335 · STUDY IN CONTEXT

Sunitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Source null

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primary · POSTED

Ability to remain on treatment without dose reduction

Source null

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secondary · POSTED

Time to disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Source null

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secondary · POSTED

Time from start of treatment until death from any cause.

Source null

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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-hypopharyngeal-cancer-recurrent-58d713f9
nct id: NCT00387335
trial label: Sunitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
applicability: unclear
applicability note: Attached because the study's own record describes recurrent 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: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00387335
outcome key
om-0000
source section id
NCT00387335-om-0000
source outcome index
0
endpoint
Objective Tumor Response Rate (Complete Response [CR] and Partial Response [PR]) Using RECIST Criteria
endpoint definition
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
time origin
While patient remains on treatment, up to 30 weeks
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-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00387335
outcome key
om-0001
source section id
NCT00387335-om-0001
source outcome index
1
endpoint
Feasibility of Treatment
endpoint definition
Ability to remain on treatment without dose reduction
time origin
While patient remains on treatment, up to 30 weeks
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-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00387335
outcome key
om-0002
source section id
NCT00387335-om-0002
source outcome index
2
endpoint
Progression-free Survival
endpoint definition
Time to disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
time origin
Up to 2 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-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00387335
outcome key
om-0003
source section id
NCT00387335-om-0003
source outcome index
3
endpoint
Overall Survival
endpoint definition
Time from start of treatment until death from any cause.
time origin
Up to two 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-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00387335
outcome key
om-0000
arm key
OG000
arm label
Sunitinib -- Cohort A
regimen
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387335-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00387335
outcome key
om-0000
arm key
OG001
arm label
Sunitinib -- Cohort B
regimen
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387335-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00387335
outcome key
om-0001
arm key
OG000
arm label
Sunitinib -- Cohort A
regimen
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387335-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00387335
outcome key
om-0001
arm key
OG001
arm label
Sunitinib -- Cohort B
regimen
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387335-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00387335
outcome key
om-0002
arm key
OG000
arm label
Sunitinib -- Cohort A
regimen
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387335-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00387335
outcome key
om-0002
arm key
OG001
arm label
Sunitinib -- Cohort B
regimen
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387335-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00387335
outcome key
om-0003
arm key
OG000
arm label
Sunitinib -- Cohort A
regimen
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387335-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00387335
outcome key
om-0003
arm key
OG001
arm label
Sunitinib -- Cohort B
regimen
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387335-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00387335
harm key
EG000
source section id
NCT00387335-ae
event group key
EG000
event group label
Sunitinib -- Cohort A
serious affected
3
serious at risk
15
other affected
14
other at risk
15
frequency threshold
5
collection period
Up to two years
event definition
Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
undenominated 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-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00387335
harm key
EG001
source section id
NCT00387335-ae
event group key
EG001
event group label
Sunitinib -- Cohort B
serious affected
1
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
Up to two years
event definition
Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
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