NCT00095628 · STUDY IN CONTEXT

SB-715992 in Treating Patients With Recurrent 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.

exploratory · POSTED

Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.

Source null

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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 lesion

20 eligible patients were analyzed

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secondary · 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 lesion

Data were not collected because 0 participants showed a response.

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secondary · POSTED

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease.

Source null

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secondary · POSTED

Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.

Source null

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secondary · POSTED

Time to progression (TTP) is defined as the time from enrolment onto the study until progression or death. The Kaplan-Meier method was used to estimate TTP.

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: NCT00095628
trial label: SB-715992 in Treating Patients With Recurrent 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: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00095628
outcome key
om-0005
source section id
NCT00095628-om-0005
source outcome index
5
endpoint
1 Year Overall Survival
endpoint definition
Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.
time origin
12 months
analysis role
exploratory
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
NCT00095628
outcome key
om-0000
source section id
NCT00095628-om-0000
source outcome index
0
endpoint
Antitumor Activity of SB-715992 Using Objective Response Rates (Partial and Complete Responses)
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 lesion
time origin
Up to 18 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
20 eligible patients were analyzed
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
NCT00095628
outcome key
om-0001
source section id
NCT00095628-om-0001
source outcome index
1
endpoint
Duration of Objective Response
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 lesion
time origin
Up to 18 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Data were not collected because 0 participants showed a response.
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
NCT00095628
outcome key
om-0002
source section id
NCT00095628-om-0002
source outcome index
2
endpoint
Number of Participants With Clinical and Objective Stable Disease
endpoint definition
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease.
time origin
Up to 18 months
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
NCT00095628
outcome key
om-0003
source section id
NCT00095628-om-0003
source outcome index
3
endpoint
Median Overall Survival of SB-715992
endpoint definition
Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.
time origin
Up to 18 months
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
NCT00095628
outcome key
om-0004
source section id
NCT00095628-om-0004
source outcome index
4
endpoint
Median Time to Progression
endpoint definition
Time to progression (TTP) is defined as the time from enrolment onto the study until progression or death. The Kaplan-Meier method was used to estimate TTP.
time origin
Up to 18 months
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
NCT00095628
outcome key
om-0000
arm key
OG000
arm label
Treatment (Ispinesib)
regimen
Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00095628-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00095628
outcome key
om-0001
arm key
OG000
arm label
Treatment (Ispinesib)
regimen
Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00095628-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00095628
outcome key
om-0002
arm key
OG000
arm label
Treatment (Ispinesib)
regimen
Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00095628-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00095628
outcome key
om-0003
arm key
OG000
arm label
Treatment (Ispinesib)
regimen
Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00095628-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00095628
outcome key
om-0004
arm key
OG000
arm label
Treatment (Ispinesib)
regimen
Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00095628-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00095628
outcome key
om-0005
arm key
OG000
arm label
Treatment (Ispinesib)
regimen
Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00095628-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00095628
harm key
EG000
source section id
NCT00095628-ae
event group key
EG000
event group label
Treatment (Ispinesib)
serious affected
6
serious at risk
20
other affected
20
other at risk
20
frequency threshold
5
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

setting source links

Preserved source evidence · Not medical advice